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Background and Aims: Serrated polyps (SPs) are precursors to 15% to 20% of colorectal cancers (CRCs). However, there are uncertainties regarding which SPs require surveillance and at what intervals, with recommendations adapted from those for adenomas in the absence of solid evidence. Our aim was to assess which SP risk characteristics relate to a higher risk of metachronous CRC or advanced polyps., Methods: We systematically searched PubMed, Embase, and Cochrane for cohort studies, case-control studies, and clinical trials from inception to December 31, 2023, of CRC or advanced polyps (advanced adenoma [AA] or advanced SP) incidence at surveillance stratified by baseline SP size, dysplasia, location, and multiplicity. We defined advanced SPs as those ≥10 mm or with dysplasia. CRC and advanced polyp incidence per 1000 person-years were estimated. We performed a meta-analysis by calculating pooled relative risks (RRs) using a random-effects model., Results: A total of 5903 studies were reviewed, and 14 were included with 493,949 patients (mean age, 59.5 years; 55% men). The mean follow-up was 4.9 years. CRC incidence per 1000 person-years was 2.09 (95% confidence interval [CI], 1.29-2.90) for advanced SPs, 1.52 (95% CI, 0.78-2.25) for SPs of ≥10 mm, 5.86 (95% CI, 2.16-9.56) for SPs with dysplasia, 1.18 (95% CI, 0.77-1.60) for proximal SPs, 0.52 (95% CI, 0.08-1.12) for ≥3 SPs, 0.50 (95% CI, 0.35-0.66) for nonadvanced SPs, and 0.44 (95% CI, 0.41-0.46) for normal colonoscopy findings. Metachronous CRC risk was higher in advanced SPs versus nonadvanced SPs (RR, 1.84; 95% CI, 1.11-3.04) and versus normal colonoscopy findings (RR, 2.92; 95% CI, 2.26-3.77), in SPs of ≥10 mm versus <10 mm (RR, 2.61; 95% CI, 1.43-4.77) and versus normal colonoscopy findings (RR: 3.52; 95% CI, 2.17-5.69); and in SPs with dysplasia versus normal colonoscopy findings (RR: 2.71; 95% CI, 2.00-3.67). No increase in CRC or advanced polyp risk was found in patients with proximal versus distal SPs, nor in ≥3 SPs versus 1 or 2 SPs., Conclusions: CRC risk is significantly higher in patients with baseline advanced SPs after 4.9 years of follow-up, with risk magnitudes similar to those described for AA, supporting the current recommendation for 3-year surveillance in patients with advanced SPs., Competing Interests: Disclosure The following authors disclosed financial relationships: U. Ladabaum: Advisor for UniversalDx, Lean Medical, Vivante, and Kohler Ventures; consultant for Medtronic, Clinical Genomics, Guardant Health, Freenome and CheckCap. C. Hassan: Consultant for ERBE, Fujifilm, Odin, and Olympus; R. Jover: Advisor for MSD, Norgine, Alpha.Sigma, and GI Supply. All other authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Resection of colorectal polyps has been shown to decrease the incidence and mortality of colorectal cancer. Large nonpedunculated colorectal polyps are often referred to expert centers for endoscopic resection, which requires relevant information to be conveyed to the therapeutic endoscopist to allow for triage and planning of resection technique. The primary objective of this study was to establish minimum expected standards for the referral of large nonpedunculated colonic polyps for potential endoscopic resection., Methods: A Delphi method was used to establish consensus on minimum expected standards for the referral of large colorectal polyps among a panel of international endoscopy experts. The expert panel was recruited through purposive sampling, and 3 rounds of surveys were conducted to achieve consensus. Quantitative and qualitative data were analyzed for each round., Results: A total of 24 international experts from diverse continents participated in the Delphi study, resulting in consensus on 19 statements related to the referral of large colorectal polyps. The identified factors, including patient demographic characteristics, relevant medications, lesion factors, photodocumentation, and the presence of a tattoo, were deemed important for conveying the necessary information to therapeutic endoscopists. The mean scores for the statements, which were scored on a scale of 1 to 10, ranged from 7.04 to 9.29, with high percentages of experts considering most statements as a very high priority. Subgroup analysis according to continent revealed some variations in consensus rates among experts from different regions., Conclusions: The identified consensus statements can aid in improving the triage and planning of resection techniques for large colorectal polyps, ultimately contributing to the reduction of colorectal cancer incidence and mortality., Competing Interests: Disclosure The following authors disclosed financial relationships: A. Sethi: consultant for Boston Scientific, Interscope, Medtronic, and Olympus; research support from Boston Scientific and Fujifilm; advisory board member for Endosound. K. Mönkemüller: consultant for Ovesco USA and Ovesco Germany. T. Pavic: speaker for Olympus and Boston Scientific. M. J. Bourke: research support for ethics-approved studies from Cook Medical, Olympus Medical, and Boston Scientific. P. Saxena: consultant for Boston Scientific, Ambu, and Erbe. D. K. Rex: Consultant for Olympus Corporation, Boston Scientific, Braintree Laboratories, Norgine, Medtronic, and Acacia Pharmaceuticals; research support from Olympus Corporation, Medivators, Erbe USA Inc, and Braintree Laboratories; shareholder with Satisfai Health. U. D. Siddiqui: research, consultant, and speaker for Olympus and Boston Scientific; and consultant and speaker for CONMED, Cook, and Medtronic. M. Pellisé: clinical advisory boards for Fujifilm Europe and Olympus; clinical advisory board and share options in MiWEndo; speaker fees from Casen Recordati, Norgine Iberia, Fujifilm, Mayoli, Medtronic, and Olympus; and research funding from Fujifilm, Casen Recordati, Ziuz, and 3-D Matrix. J. D. Mosko: Consulting: Boston Scientific, Fuji, Medtronic, Pendopharm, and Steris; research funding from Boston Scientific and Vantage/ERBE. C. W. Teshima: speaker for Medtronic and Boston Scientific; and consultant for Boston Scientific. G. R. May: consultant for Olympus; and speaker for Pentax, Fuji, and Medtronic. S. C. Grover: research grants and personal fees from AbbVie and Ferring Pharmaceuticals; personal fees from Takeda, Sanofi, and BioJAMP; education grants from Janssen; and equity shares in Volo Healthcare. C. Hassan: consultant for Fujifilm and Medtronic; and research grants from Fujifilm and NEC. A. Repici: consultant for Fujifilm, Olympus Corp, and Medtronic; and research grants from Fujifilm and NEC. P. Sharma: consultant for Olympus Corporation, Boston Scientific, Salix Pharmaceuticals, Cipla, Medtronic, Takeda, Samsung Bioepis, and CDx; and grant support from ERBE and Fujifilm. R. Bechara: consultant for Olympus, Pentax, Vantage, Medtronic, and Pendopharm. A. Shaukat: Consultant for Itertive Health, Freenome, UniversalDx, and Motus GI. All other authors disclosed no relevant financial disclosures or conflicts of interest to declare. The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The American Society for Gastrointestinal Endoscopy (ASGE) AI Task Force along with experts in endoscopy, technology space, regulatory authorities, and other medical subspecialties initiated a consensus process that analyzed the current literature, highlighted potential areas, and outlined the necessary research in artificial intelligence (AI) to allow a clearer understanding of AI as it pertains to endoscopy currently., Methods: A modified Delphi process was used to develop these consensus statements., Results: Statement 1: Current advances in AI allow for the development of AI-based algorithms that can be applied to endoscopy to augment endoscopist performance in detection and characterization of endoscopic lesions. Statement 2: Computer vision-based algorithms provide opportunities to redefine quality metrics in endoscopy using AI, which can be standardized and can reduce subjectivity in reporting quality metrics. Natural language processing-based algorithms can help with the data abstraction needed for reporting current quality metrics in GI endoscopy effortlessly. Statement 3: AI technologies can support smart endoscopy suites, which may help optimize workflows in the endoscopy suite, including automated documentation. Statement 4: Using AI and machine learning helps in predictive modeling, diagnosis, and prognostication. High-quality data with multidimensionality are needed for risk prediction, prognostication of specific clinical conditions, and their outcomes when using machine learning methods. Statement 5: Big data and cloud-based tools can help advance clinical research in gastroenterology. Multimodal data are key to understanding the maximal extent of the disease state and unlocking treatment options. Statement 6: Understanding how to evaluate AI algorithms in the gastroenterology literature and clinical trials is important for gastroenterologists, trainees, and researchers, and hence education efforts by GI societies are needed. Statement 7: Several challenges regarding integrating AI solutions into the clinical practice of endoscopy exist, including understanding the role of human-AI interaction. Transparency, interpretability, and explainability of AI algorithms play a key role in their clinical adoption in GI endoscopy. Developing appropriate AI governance, data procurement, and tools needed for the AI lifecycle are critical for the successful implementation of AI into clinical practice. Statement 8: For payment of AI in endoscopy, a thorough evaluation of the potential value proposition for AI systems may help guide purchasing decisions in endoscopy. Reliable cost-effectiveness studies to guide reimbursement are needed. Statement 9: Relevant clinical outcomes and performance metrics for AI in gastroenterology are currently not well defined. To improve the quality and interpretability of research in the field, steps need to be taken to define these evidence standards. Statement 10: A balanced view of AI technologies and active collaboration between the medical technology industry, computer scientists, gastroenterologists, and researchers are critical for the meaningful advancement of AI in gastroenterology., Conclusions: The consensus process led by the ASGE AI Task Force and experts from various disciplines has shed light on the potential of AI in endoscopy and gastroenterology. AI-based algorithms have shown promise in augmenting endoscopist performance, redefining quality metrics, optimizing workflows, and aiding in predictive modeling and diagnosis. However, challenges remain in evaluating AI algorithms, ensuring transparency and interpretability, addressing governance and data procurement, determining payment models, defining relevant clinical outcomes, and fostering collaboration between stakeholders. Addressing these challenges while maintaining a balanced perspective is crucial for the meaningful advancement of AI in gastroenterology., Competing Interests: Disclosure The following authors disclosed financial relationships: S. Parasa: Consultant for Medtronic and Microsoft Research; advisory board for the Allen Institute for Artificial Intelligence and Fujifilm; research support from Fujifilm. T. Berzin: Consultant for Medtronic, Wision AI, Magentiq Eye, RSIP Vision, and Docbot AI. C. Leggett: Consultant for Verily Life Sciences. S. Gross: Consultant for Medtronic and Iterative Scopes. A. Repici: Research support from Fujifilm, Boston Scientific Corporation, and Norgine; speaker for Boston Scientific Corporation and Norgine. O. F. Ahmad: Speaker for Olympus Corporation and Medtronic. A. Chiang: Employee at Medtronic. N. Coelho-Prabhu: Scientific advisory board for Iterative Health. J. Cohen: Consultant for Olympus and Micro-Tech; stock in GI Windows, Virtual Health Partners, and Rom-Tech; owner of MD Medical Navigators. E. Dekker: Research support from Fujifilm; consultant for Fujifilm, Olympus, Ambu, and InterVenn; speaker for Olympus, Fujifilm, GI Supply, IPSEN, PAION, and Norgine. R. N. Keswani: Consultant for Boston Scientific Corporation and Medtronic. C. E. Kahn: Travel compensation from Sectra USA; advisory council for Epic Corporation. C. Hassan: Consultant for Odin, Fujifilm, Olympus, and NEC. P. Mountney: Employment relationship with Odin Medical Limited and Olympus Medical. J. Ng: Chief executive officer and founder of Iterative Health. Y. Mori: Consultant for Olympus; speaker for Olympus; device loan from Olympus; royalties from Cybernet System. S. Thakkar: Consultant for Boston Scientific Corporation and Medtronic; advisor for Iterative Scopes. I. Waxman: Consultant for Medtronic, BSCI, and Cook Medical; advisory board for Magentiq Eye. M. B. Wallace: Consultant for Boston Scientific Corporation, Cosmo/Aries Pharmaceuticals, Verily, Endiatix, Intervenn, AlphaMed UAE, Fujifilm, and ClearNote; research support from Cosmo/Aries Pharmaceuticals and Boston Scientific Corporation; independent contractor for Olympus, Medtronic, and Ninepoint Medical; stock in Virgo Inc. P. Sharma: Consultant for Bausch, Boston Scientific Corporation, CDx Labs, Covidien LP, Exact Sciences, Fujifilm Medical Systems USA, Inc, Lucid, Lumendi, Medtronic, Olympus America, Inc, and Salix; research support from Cosmo Pharmaceuticals, Covidien, Docbot, Erbe USA Inc, Fujifilm Holdings America Corporation, Ironwood Pharmaceuticals, Inc, Medtronic USA, Inc, Olympus, Salix, and US Endoscopy. All other authors disclosed no financial relationships., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Despite advances in EMR techniques, a high polyp recurrence rate remains a challenge. Due to the scarcity of direct comparisons, we performed an indirect comparison of conventional EMR (EMR alone), underwater EMR (U-EMR), and EMR + adjuvant thermal ablation of polypectomy margins to assess polyp recurrence rates., Methods: Electronic databases were searched from inception to January 12, 2023, for studies reporting polyp recurrence rates after EMR for large nonpedunculated polyps (>15 mm) with or without adjuvant techniques (snare tip soft coagulation [STSC]/argon plasma coagulation [APC]). An indirect comparison was performed by using the frequentist method. The p-score was calculated to identify preferred intervention. Publication bias was assessed by using a comparison-adjusted funnel plot., Results: A total of 9 full articles were identified. On direct comparisons, EMR + STSC had 82% reduced odds (odds ratio, .18; 95% confidence interval, .13-.26; P < .001), whereas U-EMR alone had 77% reduced odds (odds ratio, .23; 95% confidence interval, .08-.67; P = .007) of polyp recurrence compared with EMR alone. On indirect comparison, all interventions had significantly lower odds of polyp recurrence compared with EMR alone. The p-score ranking showed that EMR + STSC seems a potential first method in reducing the odds of polyp recurrence, followed by U-EMR, EMR + APC, and EMR alone., Conclusions: EMR + STSC seems to provide favorable odds for reducing polyp recurrence postresection for large nonpedunculated polyps. Standardization of methods to detect residual polyp and prevent polyp recurrence at the time of EMR are required., Competing Interests: Disclosure The following authors disclosed financial relationships: C. Hassan and A. Repici: consultants for Fujifilm and Olympus; D. Rex: consultant for Olympus Corporation, Boston Scientific, Braintree Laboratories, Norgine, Medtronic, Acacia Pharmaceuticals; received research support from Olympus Corporation, Medivators, Erbe USA Inc, and Braintree Laboratories. D. Radadiya: consultant for Castle Biosciences. P. Sharma: consultant for Boston Scientific and Olympus Inc; grant support from US Endoscopy, Medtronic, Fujifilm, Ironwood, Cosmo Pharmaceuticals, and Erbe. All other authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The optimal endoscopic resection method of challenging colorectal lesions (ie, adenomatous recurrences, nongranular laterally spreading tumors [LST-NGs], lesions without lifting sign <30 mm) is still under debate. The aim of this study was to directly compare endoscopic submucosal dissection (ESD) and endoscopic full-thickness resection (EFTR) for the resection of challenging colorectal lesions in a randomized trial., Methods: A multicenter, prospective, randomized study was performed in 4 Italian referral centers. Consecutive patients referred for endoscopic resection of challenging lesions were randomly assigned to undergo EFTR or ESD. Primary outcomes were complete (R0) resection and en bloc resection of lesions. Technical success, procedure time, procedure speed, area of the resected specimen, adverse event rate, and local recurrence rate at 6 months were also compared., Results: Overall, 90 patients were included in the study, equally representing the 3 challenging lesion types. Age and sex were comparable in the 2 groups. En bloc resection was obtained in 95.5% of the EFTR group and in 93.3% of the ESD group. R0 resection rate was comparable in the 2 groups (EFTR vs ESD, 42 [93.3%] vs 36 [80%]; P = .06). The EFTR group exhibited a significantly shorter total procedure time (25.6 ± 10.6 minutes vs 76.7 ± 26.4 minutes, P ≤ .01), as well as overall procedure speed (16.8 ± 11.8 mm 2 /min vs 11.9 ± 9.2 mm 2 /min, P = .03). The EFTR group had a significantly smaller mean lesion size (21.6 ± 8.3 mm vs 28.7 ± 7.7 mm, P ≤ .01). Adverse events were reported less frequently in patients in the EFTR group (4.44% vs 15.5%, P = .04)., Conclusions: EFTR is comparable to ESD in the treatment of challenging colorectal lesions in terms of safety and efficacy. EFTR is considerably faster than ESD in the treatment of nonlifting lesions and adenoma recurrences. (Clinical trial registration number: NCT05502276.)., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The role of the newer EUS fine-needle biopsy needles in lymphadenopathies (LAs) is still under evaluation. We aimed to evaluate the diagnostic accuracy and adverse event rate of EUS-guided fine-needle biopsy sampling (EUS-FNB) in diagnosing LAs., Methods: From June 2015 to June 2022, all patients referred to 4 institutions for EUS-FNB of mediastinal and abdominal LAs were enrolled. Twenty-two-gauge Franseen tip or 25-gauge fork-tip needles were used. The criterion standard for positive results was surgery or imaging and clinical evolution over a follow-up of at least 1 year., Results: One hundred consecutive patients were enrolled, consisting of those with a new diagnosis of LA (40%), presence of LA with a previous history of neoplasia (51%), or suspected lymphoproliferative disease (9%). EUS-FNB was technically feasible in all LA patients with 2 to 3 passes (mean, 2.62 ± .93). The overall sensitivity, positive predictive value, specificity, negative predictive value, and accuracy for EUS-FNB were 96.20%, 100%, 100%, 87.50%, and 97.00%, respectively. Histologic analysis was feasible in 89% of cases. Cytologic evaluation was performed in 67% of specimens. A statistical difference between the accuracy of the 22-gauge or 25-gauge needle (P = .63) was not found. A subanalysis on lymphoproliferative disease revealed a sensitivity and accuracy of 89.29% and 90.0%, respectively. No adverse events were recorded., Conclusions: EUS-FNB with new end-cutting needles is a valuable and safe method to diagnose LAs. The high quality of histologic cores and the good amount of tissue allowed a complete immunohistochemical analysis of metastatic LAs and precise subtyping of the lymphomas. (Clinical trial registration number: NCT02855151.)., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Real-world data on the adverse events and the survival benefit of Barrett's endoscopic therapy (BET) are limited. The aim of this study was to examine the safety and effectiveness (survival benefit) of BET in patients with neoplastic Barrett's esophagus (BE)., Methods: An electronic health record-based database (TriNetX) was used to select patients with BE with dysplasia and esophageal adenocarcinoma (EAC) from 2016 to 2020. Primary outcome was 3-year mortality among patients with high-grade dysplasia (HGD) or EAC who underwent BET versus 2 comparison cohorts: patients with HGD or EAC who had not undergone BET and patients with GERD but no BE/EAC. Secondary outcome was adverse events (esophageal perforation, upper GI bleeding, chest pain, and esophageal stricture) after BET. To control for confounding variables, 1:1 propensity score matching was performed., Results: We identified 27,556 patients with BE and dysplasia, of whom 5295 underwent BET. After propensity score matching, patients with HGD and EAC who underwent BET had significantly lower 3-year mortality (HGD risk ratio [RR], .59; 95% CI, .49-.71; EAC RR, .53; 95% CI, .44-.65) compared with corresponding cohorts who did not undergo BET (P < .001). There was no difference in median 3-year mortality between control subjects (GERD without BE/EAC) compared with patients with HGD (RR, 1.04; 95% CI, .84-1.27) who underwent BET. Finally, there was no difference in median 3-year mortality between patients who underwent BET compared with patients who underwent esophagectomy among both HGD (RR, .67; 95% CI, .39-1.14; P =.14) and EAC (RR, .73; 95% CI, .47-1.13; P = .14). Esophageal stricture was the most common adverse event (6.5%) after BET., Conclusions: Real-world, population-based evidence from this large database shows that endoscopic therapy is safe and effective for patients with BE. Endoscopic therapy is associated with a significantly lower 3-year mortality; however, it leads to esophageal strictures in 6.5% of treated patients., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Evidence is limited on the comparative diagnostic performance of tissue sampling techniques for EUS-guided fine-needle biopsy sampling of pancreatic masses. We performed a systematic review with network meta-analysis to compare these techniques., Methods: Rates of sample adequacy, blood contamination, and tissue integrity using fine-needle biopsy sampling needles were evaluated. Direct and indirect comparisons were performed among the slow-pull, dry-suction, modified wet-suction, or no-suction techniques. Results are expressed as risk ratio (RR) and 95% confidence interval (CI)., Results: Overall, 9 randomized controlled trials (756 patients) were identified. On network meta-analysis, the no-suction technique was significantly inferior to the other techniques (RR, .85 [95% CI, .78-.92] vs slow pull; RR, .85 [95% CI, .78-.92] vs dry suction; RR, .83 [95% CI, .76-.90] vs modified wet suction) in terms of sample adequacy. Consequently, modified wet suction was shown to be the best technique (surface under the cumulative ranking curve score, .90), with the no-suction technique showing poorer performance in terms of sample adequacy (surface under the cumulative ranking curve score, .14). Dry suction was associated with significantly higher rates of blood contamination as compared with the slow-pull technique (RR, 1.44; 95% CI, 1.15-1.80), whereas no suction led to less blood contamination of samples in comparison with other techniques (RR, .71 [95% CI, .52-.97] vs slow pull; RR, .49 [95% CI, .36-.66] vs dry suction; RR, .57 [95% CI, .40-.81] vs modified wet suction). The modified wet-suction technique significantly outperformed dry suction in terms of tissue integrity of the sample (RR, 1.36; 95% CI, 1.06-1.75)., Conclusions: Modified wet suction seemed to provide high rates of integrity and adequate samples, albeit with high blood contamination. The no-suction technique performed significantly worse than other sampling strategies., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The introduction of motorized spiral enteroscopy (mSE) into clinical practice holds diagnostic and therapeutic potential for small-bowel investigations. This systematic review and meta-analysis aims to evaluate the performance of this modality in diagnosing and treating small-bowel lesions., Methods: A systematic search of MEDLINE, Cochrane, and ClinicalTrials.gov databases were performed through September 2022. The primary outcome was diagnostic success, defined as the identification of a lesion relative to the indication. Secondary outcomes were successful therapeutic manipulation, total enteroscopy rate (examination from the duodenojejunal flexion to the cecum), technical success (passage from the ligament of Treitz or ileocecal valve for anterograde and retrograde approach, respectively), and adverse event rates. We performed meta-analyses using a random-effects model, and the results are reported as percentages with 95% confidence intervals (CIs)., Results: From 2016 to 2022, 9 studies (959 patients; 42% women; mean age >45 years; 474 patients [49.4%] investigated for mid-GI bleeding/anemia) were considered eligible and included in analysis. The diagnostic success rate of mSE was 78% (95% CI, 72-84; I 2  = 78.3%). Considering secondary outcomes, total enteroscopy was attempted in 460 cases and completed with a rate of 51% (95% CI, 30-72; I 2  = 96.2%), whereas therapeutic interventions were successful in 98% of cases (95% CI, 96-100; I 2  = 79.8%) where attempted. Technical success rates were 96% (95% CI, 94-97; I 2  = 1.5%) for anterograde and 97% (95% CI, 94-100; I 2  = 38.6%) for retrograde approaches, respectively. Finally, the incidence of adverse events was 17% (95% CI, 13-21; I 2  = 65.1%), albeit most were minor adverse events (16%; 95% CI, 11-20; I 2  = 67.2%) versus major adverse events (1%; 95% CI, 0-1; I 2  = 0%)., Conclusions: mSE provides high rates of diagnostic and therapeutic success with a low prevalence of severe adverse events., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Adenoma detection rate (ADR) is still the main surrogate outcome parameter of screening colonoscopy, but most studies include mixed indications, and basic ADR is quite variable. We therefore looked at the control groups in randomized ADR trials using advanced imaging or mechanical methods to find out whether indications or other factors influence ADR levels., Methods: Patients in the control groups of randomized controlled trials (RCTs) on ADR increase using various methods were collected based on a systematic review; this control group had to use high-definition white-light endoscopy performed between 2008 and 2021. Random-effects meta-analysis was used to pool ADR in control groups and its 95% confidence interval (CI) according to clinical (indication and demographic), study setting (tandem/parallel, number of centers, sample size), and technical (type of intervention, withdrawal time) parameters. Interstudy heterogeneity was reported with the I 2 statistic. Multivariable mixed-effects meta-regression was performed for potentially relevant variables., Results: From 80 studies, 25,304 patients in the respective control groups were included. ADR in control arms varied between 8.2% and 68.1% with a high degree of heterogeneity (I 2  = 95.1%; random-effect pooled value, 37.5%; 95% CI, 34.6‒40.5). There was no difference in ADR levels between primary colonoscopy screening (12 RCTs, 15%) and mixed indications including screening/surveillance and diagnostic colonoscopy; however, fecal immunochemical testing as an indication for colonoscopy was an independent predictor of ADR (odds ratio [OR], 1.6; 95% CI, 1.1-2.4). Other well-known parameters were confirmed by our analysis such as age (OR, 1.038; 95% CI, 1.004-1.074), sex (male sex: OR, 1.02; 95% CI, 1.01-1.03), and withdrawal time (OR, 1.1; 95% CI, 1.0-1.1). The type of intervention (imaging vs mechanical) had no influence, but methodologic factors did: More recent year of publication and smaller sample size were associated with higher ADR., Conclusions: A high level of variability was found in the level of ADR in the control groups of RCTs. With regards to indications, only fecal immunochemical test-based colonoscopy studies influenced basic ADR, and primary colonoscopy screening appeared to be similar to other indications. Standardization for variables related to clinical, methodologic, and technical parameters is required to achieve generalizability and reproducibility., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Dye-based chromoendoscopy (DBC) could be effective in increasing the adenoma detection rate (ADR) in patients undergoing colonoscopy, but the technique is time-consuming and its uptake is limited. We aimed to assess the effect of DBC on ADR based on available randomized controlled trials (RCTs)., Methods: Four databases were searched up to April 2022 for RCTs comparing DBC with conventional colonoscopy (CC) in terms of ADR, advanced ADR, and sessile serrated adenoma detection rate as well as the mean adenomas per patient and non-neoplastic lesions. Relative risk (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes were calculated using random-effect models. The I 2 test was used for quantifying heterogeneity. Risk of bias was evaluated with the Cochrane tool., Results: Overall, 10 RCTs (5334 patients) were included. Indication for colonoscopy was screening or surveillance (3 studies) and mixed (7 studies). Pooled ADR was higher in the DBC group versus the CC group (95% CI, 48.1% [41.4%-54.8%] vs 39.3% [33.5%-46.4%]; RR, 1.20 [1.11-1.29]), with low heterogeneity (I 2  = 29%). This effect was consistent for advanced ADR (RR, 1.21 [1.03-1.42]; I 2  = .0%), sessile serrated adenomas (6.1% vs 3.5%; RR, 1.68 [1.15-2.47]; I 2  = 9.8%), and mean adenomas per patient (MD, .24 [.17-.31]) overall and in the right-sided colon (MD, .28 [.14-.43]). A subgroup analysis considering only trials using high-definition white-light endoscopy reduced the heterogeneity while still showing a significant increase in adenoma detection with DBC: 51.6% (95% confidence interval [CI], 47.1%-56.1%) and 59.1% (95% CI, 54.7-63.3%), RR = 1.14 (95% CI, 1.06-1.23), P = .0004, I 2 = .0%, P = .50., Conclusions: Meta-analysis of RCTs showed that DBC increases key quality parameters in colonoscopy, supporting its use in everyday clinical practice., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Evidence is limited on the comparative diagnostic performance of newer end-cutting fine-needle biopsy (FNB) needles for tissue sampling of pancreatic masses. We performed a systematic review with network meta-analysis to compare the diagnostic accuracy of available FNB needles for sampling of solid pancreatic lesions., Methods: A systematic literature review (Medline and Cochrane Database) was conducted for studies evaluating the accuracy of newer FNB needles in adults undergoing EUS-guided sampling of solid pancreatic masses. The primary outcome was diagnostic accuracy. Secondary outcomes were sample adequacy, diagnostic sensitivity, specificity, and adverse event rate. We performed pairwise and network meta-analyses and appraised the quality of evidence using Grading of Recommendations Assessment, Development and Evaluation methodology., Results: Overall, 16 RCTs (1934 patients) were identified. On network meta-analysis, Franseen needles (Acquire; Boston Scientific, Marlborough, Mass, USA) significantly outperformed reverse-bevel needles (risk ratio [RR], 1.21 [95% confidence interval {CI}, 1.05-1.40] for accuracy and 1.31 [95% CI, 1.05-1.22] for adequacy) and FNA needles (RR, 1.21 [95% CI, 1.01-1.25] for accuracy and 1.07 [95% CI, 1.02-1.13] for adequacy). Likewise, the Fork-tip needle (SharkCore; Medtronic, Dublin, Ireland) was significantly superior to the reverse-bevel needle (RR, 1.17 [95% CI, 1.03-1.33] for accuracy and 1.09 [95% CI, 1.02-1.16] for adequacy) and to the FNA needle (RR, 1.09 [95% CI, 1.01-1.19] for accuracy and 1.03 [95% CI, 1.01-1.07] for adequacy). Other comparisons did not achieve statistical significance. As a consequence, Franseen (surface under the cumulative ranking score, .89 for accuracy and .94 for adequacy) and Fork-tip needles (surface under the cumulative ranking score, .76 for accuracy and .73 for adequacy) ranked as the 2 highest-performing FNB needles. When considering different needle sizes, 25-gauge Franseen and 25-gauge Fork-tip needles were not superior to 22-gauge reverse-bevel needles (RR, 1.18 [95% CI, .96-1.46] and 1.04 [95% CI, .62-1.52]). None of the tested needles was significantly superior to the other FNB devices or to FNA needles when rapid onsite cytologic evaluation was available., Conclusions: Franseen and Fork-tip needles, particularly 22-gauge size, showed the highest performance for tissue sampling of pancreatic masses, with low confidence in estimates., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Artificial intelligence has been shown to be effective in polyp detection, and multiple computer-aided detection (CADe) systems have been developed. False-positive (FP) activation emerged as a possible way to benchmark CADe performance in clinical practice. The aim of this study was to validate a previously developed classification of FPs comparing the performances of different brands of approved CADe systems., Methods: We compared 2 different consecutive video libraries (40 video per arm) collected at Humanitas Research Hospital with 2 different CADe system brands (CADe A and CADe B). For each video, the number of CADe false activations, cause, and time spent by the endoscopist to examine the area erroneously highlighted were reported. The FP activations were classified according to the previously developed classification of FPs (the NOISE classification) according to their cause and relevance., Results: In CADe A 1021 FP activations were registered across the 40 videos (25.5 ± 12.2 FPs per colonoscopy), whereas in CADe B 1028 were identified (25.7 ± 13.2 FPs per colonoscopy; P = .53). Among them, 22.9 ± 9.9 (89.8% in CADe A) and 22.1 ± 10.0 (86.0% in CADe B) were because of artifacts from the bowel wall. Conversely, 2.6 ± 1.9 (10.2% in CADe A) and 3.5 ± 2.1 (14% in CADe B) were caused by bowel content (P = .45). Within CADe A each false activation required .2 ± .9 seconds, with 1.6 ± 1.0 FPs (6.3%) requiring additional time for endoscopic assessment. Comparable results were reported within CADe B with .2 ± .8 seconds spent per false activation and 1.8 ± 1.2 FPs per colonoscopy requiring additional inspection., Conclusions: The use of a standardized nomenclature provided comparable results with either of the 2 recently approved CADe systems. (Clinical trial registration number: NCT04399590.)., (Copyright © 2022. Published by Elsevier Inc.)

Background and Aims: Patients undergoing colonoscopy are often in the workforce. Therefore, colonoscopy may affect patients' work productivity in terms of missed working days and/or reduced working efficiency. We aimed to investigate the impact of colonoscopy on work productivity and factors influencing this impact., Methods: We conducted a prospective, observational, multicenter study in 10 Italian hospitals between 2016 and 2017. We collected information on individual characteristics, work productivity, symptoms, and conditions before, during, and after the procedure from patients undergoing colonoscopy for several indications using validated tools. Outcomes were interference of preparation with work, absenteeism, and impaired work performance after the procedure. We fitted multivariate logistic regression models to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for potential predictors of the outcomes., Results: Among 1137 subjects in the study, 30.5% reported at least 1 outcome. Impaired work performance was associated with bowel preparation regimen (full dose on the day of colonoscopy vs split dose: OR, 4.04; 95% CI, 1.43-11.5), symptoms during bowel preparation (high symptom score: OR, 3.21; 95% CI, 1.15-8.95), and pain during the procedure (OR, 2.47; 95% CI, 1.40-4.35). Increasing number of working hours and less comfortable jobs were associated with absenteeism (P for trend = .06) and impairment of working performance (P for trend = .01) and GI symptoms both before and after colonoscopy., Conclusions: Occupational and individual characteristics of patients should be considered when scheduling colonoscopy because this procedure may impair work productivity in up to one-third of patients. Split-dose bowel preparation, performing a painless colonoscopy, and preventing the occurrence of GI symptoms may minimize the impact of colonoscopy on work productivity., (Copyright © 2022. Published by Elsevier Inc.)

Background and Aims: Peroral endoscopic myotomy (POEM) has been recommended for achalasia treatment. To prevent the potential of infective risk, antibiotic prophylaxis is usually administered, whereas the additional need of antibiotic therapy after POEM is uncertain. The primary endpoint was to determine whether prophylaxis versus prophylaxis plus short therapy was needed after POEM., Methods: Consecutive patients scheduled for POEM were randomly assigned (1:1) to group A (prophylactic cefazolin 2 g IV) or group B (prophylaxis + cefazolin 2 g IV × 3 followed by oral amoxicillin/clavulanate 3 g/day). Infective risk was assessed by means of host response, namely body temperature and serum levels of white blood cells and C-reactive protein; immune response (the cytokines interleukin [IL]-6, IL-1β, and tumor necrosis factor-α and microbial translocation mediators lipopolysaccharide binding protein and soluble CD14); and blood cultures at time points before (t0) and after (t1, t2) POEM., Results: After POEM, none of the 124 enrolled patients (54.6 ± 12.6 years old; 64 men) developed any fever (body temperature: t0, 36.56± .49°C; t1, 36.53± .52°C; t2, 36.48± .41°C), without any differences between groups at any time point. Regarding systemic inflammation, no difference was reported between groups in serum levels of C-reactive protein and white blood cells. Considering microbial translocation mediated response, lipopolysaccharide binding protein (group A: t0, 1539 ± 168.6 pg/mL; t1, 1321 ± 149.1 pg/mL; t2, 2492 ± 283.2 pg/mL; group B: t0, 1318 ± 115.9 pg/mL; t1, 1492 ± 163.8 pg/mL; t2, 2600 ± 328.2 pg/mL) and soluble CD14 (group A: t0, 2.16 ± .15 μg/mL; t1, 1.89 ± .15 μg/mL; t2, 2.2 ± .15 μg/mL; group B: t0, 2.1 ± .13 μg/mL; t1, 2 ± .13 μg/mL; t2, 2.5 ± .2 μg/mL) were similar between the 2 groups; the immune response cytokines IL-6, IL-1β, and tumor necrosis factor-α also were similar in the 2 groups. In relation to blood cultures, at t1 the group B bacteremia rate was 3.2% (2/62) and group A was 1.6% (1/62) with no difference (P = .6). All subsequent blood cultures were negative at t2., Conclusions: According to our study, postprophylactic short-term antimicrobial therapy after POEM is not required because of a very low residual infective risk. (Clinical trial registration number: NCT03587337.)., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Adequate bowel cleansing is critical to ensure quality and safety of a colonoscopy. A novel 1-L polyethylene glycol plus ascorbate (1L-PEG+ASC) regimen was previously validated against low-volume regimens but was never compared with high-volume regimens., Methods: In a phase IV study, patients undergoing colonoscopy were randomized 1:1 to receive split-dose 1L PEG+ASC or a split-dose 4-L PEG-based regimen (4L-PEG) in 5 Italian centers. Preparation was assessed with the Boston Bowel Preparation Scale (BBPS) by local endoscopists and centralized reading, both blinded to the randomization arm. The primary endpoint was noninferiority of 1L-PEG+ASC in colon cleansing. Secondary endpoints were superiority of 1L-PEG+ASC, patient compliance, segmental colon cleansing, adenoma detection rate, tolerability, and safety., Results: Three hundred eighty-eight patients (median age, 59.8 years) were randomized between January 2019 and October 2019: 195 to 1L-PEG+ASC and 193 to 4L-PEG. Noninferiority of 1L-PEG+ASC was demonstrated for cleansing in both the entire colon (BBPS ≥ 6: 97.9% vs 93%; relative risk [RR], 1.03; 95% confidence interval [CI], 1.001-1.04; P superiority = .027) and in the right-sided colon segment (98.4% vs 96.0%; RR, 1.02; 95% CI, .99-1.02; P noninferiority = .013). Compliance was higher with 1L-PEG+ASC than with 4L-PEG (178/192 [92.7%] vs 154/190 patients [81.1%]; RR, 1.10; 95% CI, 1.05-1.12), whereas no difference was found regarding safety (moderate/severe side effects: 20.8% vs 25.8%; P = .253). No difference in adenoma detection rate (38.8% vs 43.0%) was found., Conclusions: One-liter PEG+ASC showed noninferiority compared with 4L-PEG in achieving adequate colon cleansing and provided a higher patient compliance. No differences in tolerability and safety were detected. (Clinical trial registration number: NCT03742232.)., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: EUS fine-needle biopsy (EUS-FNB) sampling is the standard procedure for diagnosis of pancreatic lesions. Fluorescence confocal microscopy (FCM) allows imaging of tissues in the fresh state, requiring minimal preparation without damage or loss of tissue. Until now, no data exist on FCM in the field of microhistologic specimens. We aimed to assess the diagnostic performance of FCM in predicting histologic adequacy of EUS-FNB samples in pancreatic solid lesions and to assess the agreement between FCM evaluation and final histology., Methods: In this single-center prospective study on consecutive patients with pancreatic lesions receiving EUS-FNB, the obtained samples have been evaluated at FCM and classified as "inadequate" or "adequate" (benign, suspicious, or malignant). The kappa test was used to quantify agreement. The diagnostic accuracy of FCM was assessed. A P < .05 was considered to be statistically significant., Results: From April 2020 to September 2020, 81 patients were enrolled. In all cases FCM showed the macro image of the sample and created a digital image. Of the samples, 92.6% was defined as adequate at the FCM evaluation and confirmed at histopathology. Histologic diagnoses were 8% benign, 17.3% atypical/suspicious, and 74.7% malignant with satisfactory agreement with the FCM evaluation (Cohen's κ coefficient, .95; 95% confidence interval [CI], .89-1.01; P = .001). The sensitivity of the FCM evaluation was 100% (95% CI, 95%-100%), specificity 66.7% (95% CI, 22.3%-95.7%), accuracy 97% (95% CI, 90.7%-99.7%), positive predictive value 97% (95% CI, 91.8%-99%), and negative predictive value 100%., Conclusions: FCM represents a new technique successfully applicable to microhistologic specimens. It provides fast information about sample adequacy in small specimens with good agreement in the final histology., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Since 2008, a plethora of research studies has compared the efficacy of water-assisted (aided) colonoscopy (WAC) and underwater resection (UWR) of colorectal lesions with standard colonoscopy. We reviewed and graded the research evidence with potential clinical application. We conducted a modified Delphi consensus among experienced colonoscopists on definitions and practice of water immersion (WI), water exchange (WE), and UWR., Methods: Major databases were searched to obtain research reports that could potentially shape clinical practice related to WAC and UWR. Pertinent references were graded (Grading of Recommendations, Assessment, Development and Evaluation). Extracted data supporting evidence-based statements were tabulated and provided to respondents. We received responses from 55 (85% surveyed) experienced colonoscopists (37 experts and 18 nonexperts in WAC) from 16 countries in 3 rounds. Voting was conducted anonymously in the second and third round, with ≥80% agreement defined as consensus. We aimed to obtain consensus in all statements., Results: In the first and the second modified Delphi rounds, 20 proposed statements were decreased to 14 and then 11 statements. After the third round, the combined responses from all respondents depicted the consensus in 11 statements (S): definitions of WI (S1) and WE (S2), procedural features (S3-S5), impact on bowel cleanliness (S6), adenoma detection (S7), pain score (S8), and UWR (S9-S11)., Conclusions: The most important consensus statements are that WI and WE are not the same in implementation and outcomes. Because studies that could potentially shape clinical practice of WAC and UWR were chosen for review, this modified Delphi consensus supports recommendations for the use of WAC in clinical practice., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. All rights reserved.)

Background and Aims: One-fourth of colorectal neoplasia are missed at screening colonoscopy, representing the main cause of interval colorectal cancer. Deep learning systems with real-time computer-aided polyp detection (CADe) showed high accuracy in artificial settings, and preliminary randomized controlled trials (RCTs) reported favorable outcomes in the clinical setting. The aim of this meta-analysis was to summarize available RCTs on the performance of CADe systems in colorectal neoplasia detection., Methods: We searched MEDLINE, EMBASE, and Cochrane Central databases until March 2020 for RCTs reporting diagnostic accuracy of CADe systems in the detection of colorectal neoplasia. The primary outcome was pooled adenoma detection rate (ADR), and secondary outcomes were adenoma per colonoscopy (APC) according to size, morphology, and location; advanced APC; polyp detection rate; polyps per colonoscopy; and sessile serrated lesions per colonoscopy. We calculated risk ratios (RRs), performed subgroup and sensitivity analyses, and assessed heterogeneity and publication bias., Results: Overall, 5 randomized controlled trials (4354 patients) were included in the final analysis. Pooled ADR was significantly higher in the CADe group than in the control group (791/2163 [36.6%] vs 558/2191 [25.2%]; RR, 1.44; 95% confidence interval [CI], 1.27-1.62; P < .01; I 2  = 42%). APC was also higher in the CADe group compared with control (1249/2163 [.58] vs 779/2191 [.36]; RR, 1.70; 95% CI, 1.53-1.89; P < .01; I 2  = 33%). APC was higher for ≤5-mm (RR, 1.69; 95% CI, 1.48-1.84), 6- to 9-mm (RR, 1.44; 95% CI, 1.19-1.75), and ≥10-mm adenomas (RR, 1.46; 95% CI, 1.04-2.06) and for proximal (RR, 1.59; 95% CI, 1.34-1.88), distal (RR, 1.68; 95% CI, 1.50-1.88), flat (RR, 1.78; 95% CI, 1.47-2.15), and polypoid morphology (RR, 1.54; 95% CI, 1.40-1.68). Regarding histology, CADe resulted in a higher sessile serrated lesion per colonoscopy (RR, 1.52; 95% CI, 1.14-2.02), whereas a nonsignificant trend for advanced ADR was found (RR, 1.35; 95% CI, .74-2.47; P = .33; I 2  = 69%). Level of evidence for RCTs was graded as moderate., Conclusions: According to available evidence, the incorporation of artificial intelligence as aid for detection of colorectal neoplasia results in a significant increase in the detection of colorectal neoplasia, and such effect is independent from main adenoma characteristics., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Many endoscopic technological innovations have claimed to increase the adenoma detection rate (ADR), but their role in population-based organized screening programs is debated., Methods: We searched PubMed, EMBASE, and Cochrane Library databases through January 2020 for randomized controlled trials (RCTs) evaluating the role of technological innovations in fecal immunochemical test (FIT)/fecal occult blood test+ subjects. The primary outcome was ADR, and secondary outcomes were advanced ADR, proximal colon ADR, mean adenoma per procedure (MAP), and cancer detection rate. We calculated pooled proportion rates (%) or risk ratio with 95% confidence interval (CI) and degree of heterogeneity (I 2 )., Results: Overall, 8 high quality RCTs met inclusion criteria with 3645 patients, 1813 (49.7%) in the intervention arm (advanced imaging, 3 studies; mechanical, 5 studies) and 1832 (50.3%) in the standard colonoscopy arm (mean age, 63.6 years). Pooled ADR was 56.5% (95% CI, 49.9%-62.9%) in the intervention arm and 55.9% (95% CI, 48.6%-63%) in the standard colonoscopy arm (relative risk [RR], 1.01; 95% CI, .93-1.10; I 2  = 50.4%). Similarly, no difference was observed for advanced imaging studies (RR, .95; 95% CI, .85-1.07; I 2  = 50.4%) or those with mechanical innovations (RR, 1.04; 95% CI, .92-1.17; I 2  = 69.49%). The pooled MAP was 1.5 in the intervention arm (95% CI, 1.2-1.8) and 1.5 in the standard colonoscopy (95% CI, 1.1-1.8), with no significant difference (unstandardized mean difference, .04; 95% CI, -.13 to .20; I 2  = 53.6%). No difference in advanced ADR, proximal colon ADR, or cancer detection was found. No significant publication bias was found., Conclusions: In our systematic review and meta-analysis, no technological improvement significantly increased detection rate of colorectal neoplasia in FIT+ subjects undergoing high-quality colonoscopy by high detectors, arguing against their implementation in organized programs., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: False positive (FP) results by computer-aided detection (CADe) hamper the efficiency of colonoscopy by extending examination time. Our aim was to develop a classification of the causes and clinical relevance of CADe FPs, and to assess the relative distribution of FPs in a real-life setting., Methods: In a post-hoc analysis of a randomized trial comparing colonoscopy with and without CADe (NCT: 04079478), we extracted 40 CADe colonoscopy videos. Using a modified Delphi process, 4 expert endoscopists identified the main domains for the reasons and clinical relevance of FPs. Then, 2 expert endoscopists manually examined each FP and classified it according to the proposed domains. The analysis was limited to the withdrawal phase., Results: The 2 main domains for the causes of CADe FPs were identified as artifacts due to either the mucosal wall or bowel content, and clinical relevance was defined as the time spent on FPs and the FP rate per minute. The mean number of FPs per colonoscopy was 27.3 ± 13.1, of which 24 ± 12 (88%) and 3.2 ± 2.6 (12%) were due to artifacts in the bowel wall and bowel content, respectively. Of the 27.3 FPs per colonoscopy, 1.6 (5.7%) required additional exploration time of 4.8 ± 6.2 seconds per FP (ie, 0.7% of the mean withdrawal time). In detail, 15 (24.2%), 33 (53.2%), and 14 (22.6%) FPs were classified as being of mild, moderate, or severe clinical relevance. The rate of FPs per minute of withdrawal time was 2.4 ± 1.2, and was higher for FPs due to artifacts from the bowel wall than for those from bowel content (2.4 ± 0.6 vs 0.3 ± 0.2, P < .001)., Conclusions: FPs by CADe are primarily due to artifacts from the bowel wall. Despite a high frequency, FPs result in a negligible 1% increase in the total withdrawal time because most of them are immediately discarded by the endoscopist., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Linked-color imaging (LCI), a new image-enhancing technology emphasizing contrast in mucosal color, has been demonstrated to substantially reduce polyp miss rate as compared with standard white-light imaging (WLI) in tandem colonoscopy studies. Whether LCI increases adenoma detection rate (ADR) remains unclear., Methods: Consecutive subjects undergoing screening colonoscopy after fecal immunochemical test (FIT) positivity were 1:1 randomized to undergo colonoscopy with LCI or WLI, both in high-definition systems. Insertion and withdrawal phases of each colonoscopy were carried out using the same assigned light. Experienced endoscopists from 7 Italian centers participated in the study. Randomization was stratified by gender, age, and screening round. The primary outcome measure was represented by ADR., Results: Of 704 eligible subjects, 649 were included (48.9% men, mean age ± standard deviation, 60.8 ± 7.3 years) and randomized to LCI (n = 326) or WLI (n = 323) colonoscopy. The ADR was higher in the LCI group (51.8%) than in the WLI group (43.7%) (relative risk, 1.19; 95% confidence interval, 1.01-1.40). The proportions of patients with advanced adenomas and sessile serrated lesions were, respectively, 21.2% and 8.6% in the LCI arm and 18.9% and 5.9% in the WLI arm (not significant for both comparisons). At multivariate analysis, LCI was independently associated with ADR, along with male gender, increasing age, and adequate (Boston Bowel Preparation Scale score ≥6) bowel preparation. At per-polyp analysis, the mean ± standard deviation number of adenomas per colonoscopy was comparable in the LCI and WLI arms, whereas the corresponding figures for proximal adenomas was significantly higher in the LCI group (.72 ± 1.2 vs .55 ± 1.07, P = .05) CONCLUSIONS: In FIT-positive patients undergoing screening colonoscopy, the routine use of LCI significantly increased the ADR. (Clinical trial registration number: NCT03690297.)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Previous meta-analysis showed marginal benefit of high-definition white-light endoscopy (HD-WLE) over standard-definition colonoscopy (SDC) for adenoma detection, but with residual uncertainty due to inclusion of nonrandomized studies. We aimed to further assess the effect of HD-WLE on adenoma detection by including only randomized controlled trials (RCTs)., Methods: A literature search was performed for RCTs evaluating HD-WLE versus SDC in terms of adenoma, advanced adenoma, and serrated sessile adenoma detection rates as well as the mean number of adenomas per colonoscopy (MAC), the mean number of advanced adenomas per colonoscopy (MAAC), and the mean number of sessile serrated adenomas per colonoscopy (MSSAC). The effect size on study outcomes is presented as the risk ratio (RR; 95% confidence interval [CI]) or mean difference (MD; 95% CI). We assessed the strength of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach., Results: Six RCTs involving 4594 individuals (HD-WLE, 2323; SDC, 2271) were included. Clinical indications were screening (1 study), positive result for fecal occult blood test, personal/family history of colorectal cancer (1 study), and mixed indications (4 studies). Withdrawal time was similar between the 2 arms (MD, -0.06; 95% CI, -0.25 to 0.12; P = .50). The adenoma detection rate was significantly higher in the HD-WLE arm compared with the SDC arm (40% vs 35%; RR, 1.13; 95% CI, 1.05-1.22; P = .001; I 2  = 0%; GRADE, low). This effect was consistent for advanced and sessile serrated adenoma detection rates (RR, 1.33; 95% CI, 1.03-1.72; P = .03; I 2  = 0%; GRADE, low; and RR, 1.55; 95% CI, 1.05-2.28; P = .03; I 2  = 0%; GRADE, low, respectively). In contrast, the difference was not significant for MAC, MAAC, and MSSAC., Conclusions: Meta-analyses of RCT data support the use of HD-WLE in clinical practice, although the additional benefit is limited., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Gastroparesis (GP) is a chronic debilitating condition. Prior pyloric-targeted procedures are either invasive or have questionable efficacy. Gastric peroral pyloromyotomy (G-POEM) has been proposed as a minimally invasive approach. We performed a pooled analysis to evaluate the efficacy and safety of G-POEM for GP., Methods: Electronic databases (Medline, Scopus, EMBASE) were searched up to January 2019. Studies including patients who underwent G-POEM for GP were eligible. Procedural, clinical, and safety outcomes were assessed by pooling data with a random- or fixed-effect model according to the degree of heterogeneity to obtain a proportion with a 95% confidence interval., Results: Ten studies were eligible for inclusion (292 patients), and 2 of the 10 studies were prospective. Seven studies were performed in the United States, 2 in France, and 1 in China. Endoscopic pyloromyotomy was feasible in all patients. Significant symptomatic improvement was achieved after 83.9% of procedures (mean follow-up, 7.8 ± 5.5 months). When comparing the mean values of pre- and postprocedural scintigraphic evolution, there was a significant decrease of the residual percentage at 2 and 4 hours. The overall adverse events rate was 6.8%., Conclusions: G-POEM appears to be a promising approach for GP in terms of safety and efficacy outcomes in the short term., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Second-generation colon capsule endoscopy (CCE-2) has shown promising accuracy for the diagnosis of overall neoplasia. Advanced neoplasia (AN) represents the main target of colorectal cancer screening programs. Our aim was to assess the diagnostic accuracy of CCE-2 for the detection of AN in patients with a positive result for the fecal immunochemical test (FIT) who are undergoing screening., Methods: Patients aged 50 to 69 years with a positive result for the FIT in 4 population screening programs in Italy and Spain were enrolled. Screenees were asked to undergo CCE-2, followed by traditional colonoscopy (TC). TC was performed the same day or the following morning. Bowel preparation included a split-dose polyethylene glycol-based regimen, with sodium phosphate (NaP) with gastrografin as boosters. The CCE-2 video was read by an endoscopist blinded to the results of TC. The main outcomes were CCE-2 accuracy in terms of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for AN when using 2 different size thresholds for TC referral (ie, polyps ≥6 mm and ≥10 mm)., Results: Two hundred twenty-two patients were enrolled, and 178 patients completed both CCE-2 and TC (87.7%). Overall, 59 cases of AN were detected at TC. CCE-2 sensitivity was 90%, specificity was 66.1%, PPV was 57.4%, and NPV was 92.9% for AN when using a 6-mm cut-off (TC referral rate, 52.8%) and 76.7%, 90.7%, 80.7%, and 88.4% when using a 10-mm cut-off (TC referral rate, 32%), respectively. CCE-2 detected that 8 of 9 already developed colorectal cancers. Among the 41 false positives at the 6-mm cut-off, 34 (82.9%) presented with a nonadvanced adenoma at TC. Mean transit time was 4 hours and 4 minutes, and ≥70% of patients excreted the capsule within 5 hours., Conclusions: In an enriched disease setting, we showed the high sensitivity of CCE-2 for the diagnosis of AN at a 6-mm cut-off. The apparently low CCE-2 specificity is related to the choice of AN as the main outcome. (Clinical trial registration number: ISRCTN 62158762.)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Underwater EMR is an alternative way to have nonpedunculated colorectal lesions lifted before being resected. The endoscopist takes advantage of the behavior of mucosal lesions floating away from the muscular layer, once immersed in liquid. We performed a systematic review with meta-analysis to evaluate the efficacy and safety of this technique., Methods: Electronic databases (Medline, Scopus, EMBASE) were searched up to May 2018. Full articles including patients with colorectal lesions resected by the underwater EMR technique were eligible. The complete resection (primary outcome), en bloc resection, recurrence, and adverse event rates were pooled by means of a random or fixed-effect model., Results: Ten studies were eligible, providing data on 508 lesions removed from 433 patients (male/female = 239/194; mean age range 62.2-75.0 years). Six studies were performed in the United States and the other in Europe; 7 studies were prospective. The specific indications for performing underwater EMR varied widely across studies. The complete resection rate was 96.36% (95% confidence interval [CI], 91.77-98.44), with a rate of en bloc resection of 57.07% (95% CI, 43.20%-69.91%). The recurrence rate was 8.82% (95% CI, 5.78-13.25) in a mean endoscopy surveillance period of 7.7 months (range 4-15 months). The postprocedural bleeding rate was 2.85% (95% CI, 1.64-4.90). Bleeding during the procedure was always mild and was considered as part of the procedure in all series. The overall adverse event rate was 3.31% (95% CI, 1.97%-5.52%). No cases of perforation were reported., Conclusion: According to the results of this systematic review, underwater EMR appears to be an effective and extremely safe technique for resecting nonpolypoid colorectal lesions., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Hot snare polypectomy and EMR are the standard of care in resecting colorectal polyps ≥10 mm. To avoid the risk of electrocautery-induced damage, there is recent evidence about using cold snare polypectomy and cold EMR for such lesions. The aim of this pooled analysis is to report outcomes of cold snare resection for polyps ≥10 mm., Methods: PubMed/Medline, Embase, Google Scholar, and Cochrane databases were searched up to July 2018 to identify studies that performed cold snare resection for colorectal polyps ≥10 mm. Primary outcomes were adverse events (bleeding, perforation, and postpolypectomy abdominal pain), and secondary outcomes were the rates of complete resection, overall residual polyp rates, and rates for adenomas versus sessile serrated polyps (SSPs). Subgroup analysis was performed focusing on lesion size, location, and resection technique., Results: Eight studies were included in the final analysis that included 522 colorectal polyps with a mean polyp size of 17.5 mm (range, 10-60). The overall adverse event rate was 1.1% (95% confidence interval, CI, 0.2%-2.0%; I 2  = 0%). Intra- and postprocedural bleeding rates were .7% (95% CI, 0%-1.4%) and .5% (95% CI, .1%-1.2%), respectively, with abdominal pain rate being .6% (95% CI, .1%-1.3%). Polyps ≥20 mm had a higher intraprocedural bleeding rate of 1.3% (95% CI, .7%-3.3%) and abdominal pain rate of 1.2% (95% CI, .7%-3.0%) but no delayed bleedings. No perforations were reported. The complete resection rate was 99.3% (95% CI, 98.6%-100%). Overall pooled residual rates of polyps of any histology, adenomas, and SSPs were 4.1% (95% CI, .2%-8.4%), 11.1% (95% CI, 4.1%-18.1%), and 1.0% (95% CI, .4%-2.4%), respectively, during a follow-up period ranging from 154 to 258 days., Conclusions: The results of this systematic review and pooled analysis were excellent with cold snare resection of colorectal polyps >10 mm in terms of postpolypectomy bleeding, complete resection, and residual polyp rates. Randomized controlled trials comparing cold snare resection with hot snare resections of polyps ≥10 mm are required for further investigation., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The EndoRings add-on has been claimed to improve adenoma detection at colonoscopy, but available data are inconsistent. When testing a new technology, parallel and crossover methodologies measure different outcomes, leaving uncertainty about their correspondence. The aims of this study were to compare the diagnostic yield and miss rate of the EndoRings for colorectal neoplasia., Methods: Consecutive patients undergoing colonoscopy after a positive fecal immunochemical test (FIT) within an organized screening program in 7 Italian centers were randomized between a parallel (EndoRings or standard) or a crossover (EndoRings/standard or standard/EndoRings) methodology. Outcomes measures were the adenoma detection rate (ADR) and advanced adenoma detection rate (AADR) in the parallel arms and the miss rate of adenomas in the crossover arms., Results: Of 958 eligible patients, 927 (317 EndoRings; 317 standard; 142 EndoRings/standard; 151 standard/Endo-Rings) were included in the final analysis. In the parallel arms (mean ADR, 51.3%; mean AADR, 25.4%), no difference between standard and EndoRings was found for both ADR (relative risk [RR], 1.10; 95% confidence interval [CI], 0.95-1.28) and AADR (RR, 1.16; 95% CI, 0.88-1.51), as well as for the mean number of adenomas and advanced adenomas per patient (EndoRings, 1.9 ± 1.3 and 1.0 ± 1.2; standard, 2.1 ± 1.5 and 1.0 ± 1.2; P = not significant for both comparisons). In the crossover arms, no difference in the miss rate for adenomas between EndoRings and standard was found at per polyp (RR, 1.43; 95% CI, 0.97-2.10) or per-patient analysis (24% vs 26%; P = .76)., Conclusions: No statistically significant difference in diagnostic yield and miss rate between EndoRings and standard colonoscopy was detected in patients with a positive FIT result. A clinically relevant correspondence between miss and detection rates was shown, supporting a cause-effect relationship. (ISRCTN registry: ISRCTN10357435.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Right-sided lesions are often missed during standard colonoscopy (SC). A second forward-view examination or retroflexion in the right side of the colon have both been proposed as techniques to improve adenoma detection rate (ADR) in the right side of the colon. Comparative data on examining the right side of the colon with a second forward view or retroflexion is not known in a pooled analysis. We performed a systematic review of the literature to assess the yield of a second forward view compared with retroflexion examination for the detection of right-sided adenomas., Methods: A systematic literature search was performed using the following databases: PubMed, Embase, Web of Science, and Cochrane. Only full-length published articles that provided information on adenoma detection and miss rates during either a second forward view or retroflexed view of the right side of the colon after the initial standard forward withdrawal (SC) were included. The following outcomes were assessed: comparison of adenoma miss rate (AMR) for second forward view versus retroflexion after SC, AMR of SC compared with second forward view, AMR of SC compared with retroflexion, and right-sided adenoma detection with second forward view and retroflexion. Pooled rates were reported as risk difference or odds ratios (OR) with 95% confidence intervals (CI) with a P value <.05 indicating statistical significance. Statistical analysis was performed with Review Manager v5.3., Results: We identified 4 studies with 1882 patients who underwent a second forward view of the right side of the colon after an initial SC. The average age of the patients was 58.3 years. Data on right-sided ADR were available from all 4 studies for the second forward view; however, only 2 of the studies provided information on right-sided ADR with retroflexion. The pooled estimate of AMR of a single SC was 13.3% (95% CI, 6.6%-20%) compared with a second forward-view examination (n = 4), whereas it was 8.1% (3.7%-12.5%) compared with a retroflexion examination (n = 3). However, when the second forward view was compared with retroflexion in terms of AMR from an analysis of 3 eligible studies, there was no statistically significant difference (7.3% vs 6.3%; pooled OR, 1.2; 95% CI, 0.9-1.61; P = .21). Second forward view of the right side of the colon increased the right-sided ADR by 10% (n = 4; second forward view vs SC, 33.6% vs 26.7%) with a pooled risk difference of 0.09 (95% CI, 0.03-0.15; P < .01). Retroflexion increased the right-sided ADR by 6% (n = 3; retroflexion vs SC, 28.4% vs 22.7%) with a pooled risk difference of 0.06 (95% CI, 0.03-0.09; P < 01)., Conclusion: After SC withdrawal, a second forward view and retroflexed view of the right side of the colon are both associated with improvement in ADR. One of these techniques should be considered during SC to increase ADR and to improve the quality of colonoscopy., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Separate randomized controlled trials (RCTs) showed water exchange (WE) colonoscopy outperformed other techniques in minimizing insertion pain and optimizing adenoma detection rate. Longer insertion time required for removal of infused water, residual air, and feces might have hampered its wider adoption. We evaluate the impact of WE compared with air or carbon dioxide insufflation (GAS) on room turnaround efficiency measured by cecal intubation, withdrawal, and total procedure times., Methods: With a systematic search in PubMed, Embase, and Cochrane Library, we identified RCTs (published before March 18, 2018) that compared WE with GAS. We focused on parameters of turnaround efficiency and patient-centered outcomes., Results: We analyzed 8371 subjects from 17 studies. Demographics and indications were comparable. Mean cecal intubation time (± standard deviation) was WE 12.5 ± 6.1 minutes versus GAS 11.1 ± 7.0 minutes, with a mean difference of 1.4 ± 3.4 minutes. Six studies showed significant differences in insertion time, with mean cecal intubation times of 11.6 ± 5.1 minutes for WE versus 7.7 ± 5.2 minutes for GAS, with a mean difference of 3.9 ± 1.1 minutes. Mean withdrawal time was similar. Mean total procedure time was WE 26.0 ± 9.7 versus GAS 24.2 ± 9.6, with a mean difference of 1.8 ± 6.2 minutes. All mean procedure times were significantly different. Patient-centered outcomes revealed that patients examined with WE had significantly lower real-time insertion pain score, less need for sedation, and higher willingness to repeat the procedure., Conclusions: Based on parameters of procedural time, the impact of WE colonoscopy on endoscopy room turnaround yields an increase in total procedure time of about 2 minutes and is associated with significant improvement in specific patient-centered outcomes., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. All rights reserved.)

Background and Aims: Water-aided colonoscopy techniques, such as water immersion (WI) and water exchange (WE), have shown different results regarding adenoma detection rate (ADR). We determined the impact of WI and WE on ADR and other procedural outcomes versus gas (air, AI; CO 2 ) insufflation colonoscopy., Methods: A systematic search of multiple databases for randomized controlled trials comparing WI and/or WE with AI and/or CO 2 and reporting ADR was conducted. A network meta-analysis with mixed comparisons was performed. Primary outcome was ADR (overall, in the right side of the colon and by colonoscopy indication)., Results: Seventeen randomized controlled trials (10,350 patients) were included. WE showed a significantly higher overall ADR versus WI (odds ratio [OR], 1.31; 95% credible interval [CrI], 1.12-1.55) versus AI (OR, 1.40; CrI, 1.22-1.62) versus CO 2 (OR, 1.48; 95% CrI, 1.15-1.86). WE achieved the highest ADR also in the right side of the colon and in colorectal cancer screening cases (both significant vs AI and WI) as well as in patients taking a split-dose preparation (significant vs all the other techniques). The Boston Bowel Preparation Scale cleanliness score (vs AI and WI) was significantly higher for WE. Both WI and WE showed increased proportion of unsedated examinations and decreased real-time insertion pain, with WE being the least-painful insertion technique. Withdrawal time was comparable across techniques, but WE showed the longest insertion time (3-5 additional minutes)., Conclusions: WE significantly increases overall ADR, ADR in screening cases, and in the right side of the colon; it also improves colon cleanliness but requires a longer insertion time., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: SIC-8000 (Eleview) is a new U.S. Food and Drug Administration (FDA)-approved solution for submucosal injection developed to provide a long-lasting cushion to facilitate endoscopic resection maneuvers. Our aim was to compare the efficacy and safety of SIC-8000 with those of saline solution, when performing EMR of large colorectal lesions., Methods: In a randomized double-blind trial, patients undergoing EMR for colorectal non-pedunculated lesions ≥20 mm were randomized in a 1:1 ratio between SIC-8000 and saline solution as control solution in 5 tertiary centers. Endoscopists and patients were blinded to the type of submucosal solution used. Total volume to complete EMR and per lesion size and time of resection were primary endpoints; the Sydney Resection Quotient (SRQ), as well as other EMR outcomes, and the rate of adverse events were secondary endpoints. A 30-day telephone follow-up was performed. An alpha level <0.05 was considered as statistically significant., Results: Of the 327 patients screened, 226 (mean age, 66 ± 10 years; males, 56%) were enrolled in the study and randomized between the 2 submucosal agents. Of these, 211 patients (mean size of the lesions 33 ± 13 mm; Paris class Is, 36%; proximal colon, 74%) were entered in the final analysis (SIC-8000, 102; saline solution, 109). EMR was complete in all cases. The total volume needed for EMR was significantly less in the SIC-8000 arm compared with saline group (16.1 ± 9.8 mL vs 31.6 ± 32.0 mL; P < .001). This corresponded to an average volume per lesion size of 0.5 ± 0.3 mL/mm and 0.9 ± 0.6 mL/mm with SIC-8000 and saline solution, respectively (P < .001). The mean time to completely resect the lesion tended to be lower with SIC-8000 than with saline solution (19.1 ± 16.8 minutes vs 29.7 ± 68.9 minutes; P = .1). The SRQ was significantly higher with SIC-8000 compared with saline solution (10.3 ± 8.1 vs 8.0 ± 5.7; P = .04) with a trend for a lower number of resected pieces (5.7 ± 6.0 vs 6.5 ± 5.04; P = .052) and a higher rate of en bloc resections (19/102, 18.6% vs 12/111, 11.0%; P = .1). The rate of adverse events was similar between the 2 arms (SIC-8000, 18.6%; saline solution, 17%), and none of the serious adverse events (SIC-8000, 8.8%; saline solution, 10.7%) were related to the study treatment., Conclusions: In a double-blind, randomized clinical trial, a new FDA-approved agent for sub-mucosal injection appeared to be a more effective and equally safe submucosal agent for EMR injection than saline solution. (Clinical trial registration number: NCT02654418.)., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Devices used to improve polyp detection during colonoscopy have seldom been compared with each other., Methods: We performed a 3-center prospective randomized trial comparing high-definition (HD) forward-viewing colonoscopy alone to HD with Endocuff to HD with EndoRings to the full spectrum endoscopy (FUSE) system. Patients were age ≥50 years and had routine indications and intact colons. The study colonoscopists were all proven high-level detectors. The primary endpoint was adenomas per colonoscopy (APC)., Results: Among 1188 patients who completed the study, APC with Endocuff (APC mean ± standard deviation: 1.82 ± 2.58), EndoRings (1.55 ± 2.42), and standard HD colonoscopy (1.53 ± 2.33) were all higher than FUSE (1.30 ± 1.96; P < .001 for APC). The APC for Endocuff was higher than standard HD colonoscopy (P = .014). Mean cecal insertion times with FUSE (468 ± 311 seconds) and EndoRings (403 ± 263 seconds) were both longer than with Endocuff (354 ± 216 seconds; P = .006 and .018, respectively)., Conclusions: For high-level detectors at colonoscopy, forward-viewing HD instruments dominate the FUSE system, indicating that for these examiners image resolution trumps angle of view. Further, Endocuff is a dominant strategy over EndoRings and no mucosal exposure device on a forward-viewing HD colonoscope. (Clinical trial registration number: NCT02345889.)., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: EUS elastography is useful in characterizing solid pancreatic lesions (SPLs), and fractal analysis-based technology has been used to evaluate geometric complexity in oncology. The aim of this study was to evaluate EUS elastography (strain ratio) and fractal analysis for the characterization of SPLs., Methods: Consecutive patients with SPLs were prospectively enrolled between December 2015 and February 2017. Elastographic evaluation included parenchymal strain ratio (pSR) and wall strain ratio (wSR) and was performed with a new compact US processor. Elastographic images were analyzed using a computer program to determine the 3-dimensional histogram fractal dimension. A composite cytology/histology/clinical reference standard was used to assess sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating curve., Results: Overall, 102 SPLs from 100 patients were studied. At final diagnosis, 69 (68%) were malignant and 33 benign. At elastography, both pSR and wSR appeared to be significantly higher in malignant as compared with benign SPLs (pSR, 24.5 vs 6.4 [P < .001]; wSR, 56.6 vs 15.3 [P < .001]). When the best cut-off levels of pSR and wSR at 9.10 and 16.2, respectively, were used, sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating curve were 88.4%, 78.8%, 89.7%, 76.9%, and 86.7% and 91.3%, 69.7%, 86.5%, 80%, and 85.7%, respectively. Fractal analysis showed a significant statistical difference (P = .0087) between the mean surface fractal dimension of malignant lesions (D = 2.66 ± .01) versus neuroendocrine tumor (D = 2.73 ± .03) and a statistical difference for all 3 channels red, green, and blue (P < .0001)., Conclusions: EUS elastography with pSR and fractal-based analysis are useful in characterizing SPLs. (Clinical trial registration number: NCT02855151.)., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Per-oral endoscopic myotomy (POEM) represents a less invasive alternative to conventional laparoscopic Heller's myotomy (LHM) for patients with achalasia. It cannot be excluded, however, that the lack of fundoplication after POEM may result in a higher incidence of reflux disease, as compared with LHM. The aim of our study was to conduct a systematic review of prospective studies reporting the incidence of reflux disease developed after POEM and LHM., Methods: A literature search with electronic databases was performed (up to February 2017) to identify full articles on the incidence of gastroesophageal reflux symptoms and endoscopic monitoring and pH monitoring findings after POEM and LHM (with fundoplication). Proportions and rates were pooled by means of random or fixed-effects models, according to the level of heterogeneity between studies., Results: After we applied the selection criteria, 17 and 28 studies, including 1542 and 2581 participants who underwent POEM and LHM, respectively, were included. The pooled rate of postprocedural symptoms was 19.0% (95% confidence interval [CI], 15.7%-22.8%) after POEM and 8.8% (95% CI, 5.3%-14.1%) after LHM, respectively. The pooled rate estimate of abnormal acid exposure at pH monitoring was 39.0% (95% CI, 24.5%-55.8%) after POEM and 16.8% (95% CI, 10.2%-26.4%) after LHM, respectively. The rate of esophagitis after POEM was 29.4% (95% CI, 18.5%-43.3%) after POEM and 7.6% (95% CI, 4.1%-13.7%) after LHM. At meta-regression, heterogeneity was explained partly by the POEM approach and study population., Conclusion: The incidence of reflux disease appears to be significantly more frequent after POEM than after LHM with fundoplication. Monitoring pH and ensuring appropriate treatment after POEM should be considered in order to prevent long-term reflux-related adverse events., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Colon capsule endoscopy (CCE) has been recognized as an alternative for colorectal cancer (CRC) screening in average-risk people. Our aim was to prospectively assess the accuracy of CCE as a screening tool in first-degree relatives (FDRs) of people with CRC by using optical colonoscopy (OC) with segmental unblinding as the reference standard., Methods: Consecutive patients admitted with a CRC diagnosis (index cases) were prospectively evaluated and invited to contact their FDRs. Available FDRs were invited to undergo CCE and OC on the following day, with segmental unblinding of CCE results. Sensitivity, specificity, and predictive values/negative predictive values (PPV/NPV) of CCE were assessed for detecting patients with any polyp ≥6 mm and ≥10 mm., Results: A total of 177 FDRs (median age 57.0 years, 54.8% female) identified from 211 index cases were included. Both CCE and OC were completed in all the included FDRs. Overall, CCE identified 51 of 56 FDRs with polyps ≥6 mm (sensitivity 91%; 95% CI, 81-96) and correctly classified as negative 107 of 121 participants without lesions ≥6 mm (specificity 88%; 95% CI, 81-93). Per-patient positive and negative predictive values for ≥6 mm lesions were 78% (95% CI, 67-87) and 95% (95% CI, 90-98), respectively. CCE detected 24 of 27 patients with polyps ≥10 mm and correctly classified as negative 142 of 150 patients, corresponding to 89% sensitivity and 95% specificity. Post-CCE referral rates to colonoscopy were 37% and 18%, respectively., Conclusions: CCE is an accurate method to screen FDRs of patients with CRC and could be offered as an alternative to those who decline or are unfit for colonoscopy screening. (Clinical trial registration number: NCT01184781.)., (Copyright © 2018. Published by Elsevier Inc.)

Background and Aims: Submucosal injection is currently used in GI endoscopy to reduce resection risks and to perform submucosal dissection; it is usually performed via an injection needle or a needleless device. The aim of the study was to compare 2 submucosal injection modalities (needle-assisted vs needleless) by using substances with different viscosities., Methods: Needle and needleless injections were compared by assessing the efficacy of tissue elevation with 5 different substances in an ex vivo porcine model. The height of the submucosal elevation was measured 0(t0), 10(t1), and 30 minutes after injection (t2). Viscosity of the solution was also measured., Results: For both stomach and rectum, at t0, t1, and t2 no difference in the height of the elevation was found between the needle and needleless technique, irrespective of the substance. Tissue elevation in the stomach was similar between the 2 techniques at t0 (9.9 ± 1.58 vs 9.4 ± 1.3 mm, P = .3), t1 (7.2 ± 1.56 vs 6.9 ± 1.4 mm, P =. 26), and t2 (6 ± 1.6 vs 5.5 ± 1.3 mm, P = .18). No difference was found in the rectum at t1 and t2, whereas a slightly higher elevation with the needle-assisted technique was observed at t0 (t0: 12.4 ± 1.3 vs 11.2 ± 1.6 mm, P = .003; t1: 8.7 ± 1.3 vs 8.3 ± 1.5 mm; P = .32; t2: 7.0 ± 1.4 vs 7.2 ± .76 mm; P = .75). When comparing the substances with normal saline solution, more viscous solutions showed a significantly higher elevation at t0, t1, and t2 irrespective of the injection modalities and the location., Conclusions: No differences were found in the height of submucosal injection or in the persistence of such elevation when comparing needleless with needle-assisted injection, with the only minor exception of the initial elevation in the rectum, which does not appear to be clinically relevant. Viscous solutions resulted in higher and more persistent elevations as compared with normal saline solution., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)