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The peroral endoscopic myotomy (POEM) procedure, as described over 10 years ago, is a submucosal endoscopy procedure that allows access to the muscle layers throughout the gastrointestinal (GI) tract. With this access, and ability to cut the muscle fibers, POEM can be performed not only for motility disorders but for structural pathology as well, such as Zenker diverticulum. Regardless of the location, there are 4 steps to the procedure: mucosotomy, submucosal tunneling, myotomy, and mucostomy closure. This review outlines these key components as well as variations in techniques for POEM throughout the GI tract.

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 I2 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 (I2 = 29%). This effect was consistent for advanced ADR (RR, 1.21 [1.03-1.42]; I2 = .0%), sessile serrated adenomas (6.1% vs 3.5%; RR, 1.68 [1.15-2.47]; I2 = 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, I2 = .0%, P = .50. Conclusions: Meta-analysis of RCTs showed that DBC increases key quality parameters in colonoscopy, supporting its use in everyday clinical practice.

Introduction In this study, we review long-term outcomes of gastric endoscopic submucosal dissection [ESD] in western setting in light of the latest Japanese indication criteria, and examine predictors of outcomes and complications. Methods Data was collected on consecutive patients referred for gastric ESD in four participating centres from 2009 to 2021. Retrospective analysis of data with logistic regression and survival analysis was performed. Results A total of 415 patients were included. Mean age was 71.7 years, 56.4% were males. Absolute indication criteria [2018 guidelines] were fulfilled in 75.3% of patients. Median follow-up was 52 months. Post-resection histology was adenocarcinoma, HGD and LGD in 49.9%, 22.7% and 17.1% respectively. Perforation, early bleeding and delayed bleeding occurred in 2.4%, 4.3% and 3.4% respectively. En-bloc, R0 and recurrence on first endoscopic follow-up were 94.7%, 83.4% and 2.7% respectively. Relative indication [2018 Guidelines] for ESD was associated with R1 outcome [P-value 0.002]. Distal location [P-value 0.002] and increased procedure time [P-value 0.04] were significantly associated with bleeding risk, whereas scarring [P-value 0.009] and increased procedure duration [P-value 0.003] were associated with perforation. Recurrence-free survival at 2 years and 5 years was 94% and 83% respectively. Conclusion This is the largest multicenter western cohort suggesting gastric ESD is safe and effective in the western setting. A quarter of our patients fell outside of the new absolute indications for ESD, suggesting that western practice involves more advanced lesions. We identified the predictors of adverse outcomes in western practice. This should inform future practice and research.

Background Optical diagnosis of colonic polyps is poorly reproducible outside of high volume referral centers. The present study aimed to assess whether real-time artificial intelligence (AI)-assisted optical diagnosis is accurate enough to implement the leave-in-situ strategy for diminutive (≤ 5 mm) rectosigmoid polyps (DRSPs). Methods Consecutive colonoscopy outpatients with ≥ 1 DRSP were included. DRSPs were categorized as adenomas or nonadenomas by the endoscopists, who had differing expertise in optical diagnosis, with the assistance of a real-time AI system (CAD-EYE). The primary end point was ≥ 90 % negative predictive value (NPV) for adenomatous histology in high confidence AI-assisted optical diagnosis of DRSPs (Preservation and Incorporation of Valuable endoscopic Innovations [PIVI-1] threshold), with histopathology as the reference standard. The agreement between optical- and histology-based post-polypectomy surveillance intervals (≥ 90 %; PIVI-2 threshold) was also calculated according to European Society of Gastrointestinal Endoscopy (ESGE) and United States Multi-Society Task Force (USMSTF) guidelines. Results Overall 596 DRSPs were retrieved for histology in 389 patients; an AI-assisted high confidence optical diagnosis was made in 92.3 %. The NPV of AI-assisted optical diagnosis for DRSPs (PIVI-1) was 91.0 % (95 %CI 87.1 %–93.9 %). The PIVI-2 threshold was met with 97.4 % (95 %CI 95.7 %–98.9 %) and 92.6 % (95 %CI 90.0 %–95.2 %) of patients according to ESGE and USMSTF, respectively. AI-assisted optical diagnosis accuracy was significantly lower for nonexperts (82.3 %, 95 %CI 76.4 %–87.3 %) than for experts (91.9 %, 95 %CI 88.5 %–94.5 %); however, nonexperts quickly approached the performance levels of experts over time. Conclusion AI-assisted optical diagnosis matches the required PIVI thresholds. This does not however offset the need for endoscopistsʼ high level confidence and expertise. The AI system seems to be useful, especially for nonexperts.

Barrett's esophagus (BE) is a well-established risk factor for esophageal adenocarcinoma. It is recommended that patients have regular endoscopic surveillance, with the ultimate goal of detecting early-stage neoplastic lesions before they can progress to invasive carcinoma. Detection of both dysplasia or early adenocarcinoma permits curative endoscopic treatments, and with this aim, thorough endoscopic assessment is crucial and improves outcomes. The burden of missed neoplasia in BE is still far from being negligible, likely due to inappropriate endoscopic surveillance. Over the last two decades, advanced imaging techniques, moving from traditional dye-spray chromoendoscopy to more practical virtual chromoendoscopy technologies, have been introduced with the aim to enhance neoplasia detection in BE. As witnessed in other fields, artificial intelligence (AI) has revolutionized the field of diagnostic endoscopy and is set to cover a pivotal role in BE as well. The aim of this commentary is to comprehensively summarize present evidence, recent research advances, and future perspectives regarding advanced imaging technology and AI in BE; the combination of computer-aided diagnosis to a widespread adoption of advanced imaging technologies is eagerly awaited. It will also provide a useful step-by-step approach for performing high-quality endoscopy in BE, in order to increase the diagnostic yield of endoscopy in clinical practice.

ESGE suggests conventional endoscopic submucosal dissection (ESD; marking and mucosal incision followed by circumferential incision and stepwise submucosal dissection) for most esophageal and gastric lesions. ESGE suggests tunneling ESD for esophageal lesions involving more than two-thirds of the esophageal circumference. ESGE recommends the pocket-creation method for colorectal ESD, at least if traction devices are not used. The use of dedicated ESD knives with size adequate to the location/thickness of the gastrointestinal wall is recommended. It is suggested that isotonic saline or viscous solutions can be used for submucosal injection. ESGE recommends traction methods in esophageal and colorectal ESD and in selected gastric lesions. After gastric ESD, coagulation of visible vessels is recommended, and post-procedural high dose proton pump inhibitor (PPI) (or vonoprazan). ESGE recommends against routine closure of the ESD defect, except in duodenal ESD. ESGE recommends corticosteroids after resection of > 50 % of the esophageal circumference. The use of carbon dioxide when performing ESD is recommended. ESGE recommends against the performance of second-look endoscopy after ESD. ESGE recommends endoscopy/colonoscopy in the case of significant bleeding (hemodynamic instability, drop in hemoglobin > 2 g/dL, severe ongoing bleeding) to perform endoscopic hemostasis with thermal methods or clipping; hemostatic powders represent rescue therapies. ESGE recommends closure of immediate perforations with clips (through-the-scope or cap-mounted, depending on the size and shape of the perforation), as soon as possible but ideally after securing a good plane for further dissection.

Main recommendationsObesity is a chronic, relapsing, degenerative, multifactorial disease that is associated with many co-morbidities. The global increasing burden of obesity has led to calls for an urgent need for additional treatment options. Given the rapid expansion of bariatric endoscopy and bariatric surgery across Europe, the European Society of Gastrointestinal Endoscopy (ESGE) has recognized the need to formalize and enhance training in bariatric endoscopy and the endoscopic treatment of bariatric surgical adverse events. This manuscript represents the outcome of a formal Delphi process resulting in an official Position Statement of the ESGE and provides a framework to develop and maintain skills in bariatric endoscopy and the endoscopic treatment of bariatric surgical adverse events. This curriculum is set out in terms of the prerequisites prior to training, minimum number of procedures, the steps for training and quality of training, and how competence should be defined and evidenced before independent practice. 1 ESGE recommends that every endoscopist should have achieved competence in upper gastrointestinal endoscopy before commencing training in bariatric endoscopy and the endoscopic treatment of bariatric surgical adverse events. 2 Trainees in bariatric endoscopy and the endoscopic treatment of the complications of bariatric surgery should have basic knowledge of the definition, classification, and social impact of obesity, its pathophysiology, and its related co-morbidities. The recognition and management of gastrointestinal diseases that are more common in patients with obesity, along with participation in multidisciplinary teams where obese patients are evaluated, are mandatory. 3 ESGE recommends that competency in bariatric endoscopy and the endoscopic treatment of the complications of bariatric surgery can be learned by attending validated training courses on simulators initially, structured training courses, and then hands-on training in tertiary referral centers.

Summary Background Computer-aided detection (CADe) techniques based on artificial intelligence algorithms can assist endoscopists in detecting colorectal neoplasia. CADe has been associated with an increased adenoma detection rate, a key quality indicator, but the utility of CADe compared with existing advanced imaging techniques and distal attachment devices is unclear. Methods For this systematic review and network meta-analysis, we did a comprehensive search of PubMed/Medline, Embase, and Scopus databases from inception to Nov 30, 2020, for randomised controlled trials investigating the effectiveness of the following endoscopic techniques in detecting colorectal neoplasia: CADe, high definition (HD) white-light endoscopy, chromoendoscopy, or add-on devices (ie, systems that increase mucosal visualisation, such as full spectrum endoscopy [FUSE] or G-EYE balloon endoscopy). We collected data on adenoma detection rates, sessile serrated lesion detection rates, the proportion of large adenomas detected per colonoscopy, and withdrawal times. A frequentist framework, random-effects network meta-analysis was done to compare artificial intelligence with chromoendoscopy, increased mucosal visualisation systems, and HD white-light endoscopy (the control group). We estimated odds ratios (ORs) for the adenoma detection rate, sessile serrated lesion detection rate, and proportion of large adenomas detected per colonoscopy, and calculated mean differences for withdrawal time, with 95% CIs. Risk of bias and certainty of evidence were assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Findings 50 randomised controlled trials, comprising 34 445 participants, were included in our main analysis (six trials of CADe, 18 of chromoendoscopy, and 26 of increased mucosal visualisation systems). HD white-light endoscopy was the control technique in all 50 studies. Compared with the control technique, the adenoma detection rate was 7·4% higher with CADe (OR 1·78 [95% CI 1·44–2·18]), 4·4% higher with chromoendoscopy (1·22 [1·08–1·39]), and 4·1% higher with increased mucosal visualisation systems (1·16 [1·04–1·28]). CADe ranked as the superior technique for adenoma detection (with moderate confidence in hierarchical ranking); cross-comparisons of CADe with other imaging techniques showed a significant increase in the adenoma detection rate with CADe versus increased mucosal visualisation systems (OR 1·54 [95% CI 1·22–1·94]; low certainty of evidence) and with CADe versus chromoendoscopy (1·45 [1·14–1·85]; moderate certainty of evidence). When focusing on large adenomas (≥10 mm) there was a significant increase in the detection of large adenomas only with CADe (OR 1·69 [95% CI 1·10–2·60], moderate certainty of evidence) when compared to HD white-light endoscopy; CADe ranked as the superior strategy for detection of large adenomas. CADe also seemed to be the superior strategy for detection of sessile serrated lesions (with moderate confidence in hierarchical ranking), although no significant increase in the sessile serrated lesion detection rate was shown (OR 1·37 [95% CI 0·65–2·88]). No significant difference in withdrawal time was reported for CADe compared with the other techniques. Interpretation Based on the published literature, detection rates of colorectal neoplasia are higher with CADe than with other techniques such as chromoendoscopy or tools that increase mucosal visualisation, supporting wider incorporation of CADe strategies into community endoscopy services. Funding None.

Video 1At preoperative esophagram, a typical bird's beak image is shown at the gastroesophageal junction. A gastro-gastric fistula, opening from cardia to fundus, is also shown. A scope fitted with a distal clear cap is introduced. At the cardia, we see the proximal opening of the fistula. Here, we see the gastric fundus. As we go down, the gastric pouch is regular, and further down we reach the pylorus. In the retroflexed view, we recognize the neo-pylorus and the distal opening of the fistula. After submucosal injection on the anterior wall of the esophagus, a longitudinal mucosal incision is made. Submucosal tunnelling is performed using the endoscopic submucosal dissection technique. The gastroesophageal junction is reached, as confirmed by the finding of typical spindle veins. Here, we show submucosal tunnelling across the cardia, extending 2 cm into the gastric pouch. No obstacles from past surgery are encountered. Correct extension of the tunnel down into the cardia is also confirmed by visualizing a blue cushion. Dissection of a circular layer (of the muscularis) is performed and carried into the cardia. Submucosal tunnel is smoothy performed with no issues related to past surgery. Here, we demonstrate myotomy being carried into the gastric pouch across the cardia. We can see the more complex organization of muscular fibers. Again, no obstacles from past surgery are encountered. Myotomy is then completed along the entire length of the submucosal tunnel. Clip closure of the mucosal incision is eventually performed.

Video Video 1

Zenker's diverticulum (ZD) is a rare outpouching of the esophageal mucosa herniating posteriorly through Killian's triangle. Treatments of ZD aim to dissect the cricopharyngeal muscle to remove the underlying dysfunctional condition. In the last decade, a septotomy performed utilizing a flexible endoscope has been reported as a safe and effective alternative to both open surgery and rigid endoscopic diverticulotomy. More recently, Li et al described a novel endoscopic technique to treat ZD, named "submucosal tunneling endoscopic septum division", inspired by the peroral endoscopic myotomy (POEM) procedure developed for achalasia. Subsequently, the term Z-POEM was introduced and has become the most frequently used acronym to define the tunneling technique for ZD. This article describes the flexible therapeutic endoscopic strategies for treating ZD, including the novel third space approach, which seems to show promising potential in terms of clinical efficacy and safety.

Main recommendationsESGE recommends that the evaluation of superficial gastrointestinal (GI) lesions should be made by an experienced endoscopist, using high definition white-light and chromoendoscopy (virtual or dye-based).ESGE does not recommend routine performance of endoscopic ultrasonography (EUS), computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)-CT prior to endoscopic resection.ESGE recommends endoscopic submucosal dissection (ESD) as the treatment of choice for most superficial esophageal squamous cell and superficial gastric lesions.For Barrett’s esophagus (BE)-associated lesions, ESGE suggests the use of ESD for lesions suspicious of submucosal invasion (Paris type 0-Is, 0-IIc), for malignant lesions > 20 mm, and for lesions in scarred/fibrotic areas.ESGE does not recommend routine use of ESD for duodenal or small-bowel lesions.ESGE suggests that ESD should be considered for en bloc resection of colorectal (but particularly rectal) lesions with suspicion of limited submucosal invasion (demarcated depressed area with irregular surface pattern or a large protruding or bulky component, particularly if the lesions are larger than 20 mm) or for lesions that otherwise cannot be completely removed by snare-based techniques.ESGE recommends that an en bloc R0 resection of a superficial GI lesion with histology no more advanced than intramucosal cancer (no more than m2 in esophageal squamous cell carcinoma), well to moderately differentiated, with no lymphovascular invasion or ulceration, should be considered a very low risk (curative) resection, and no further staging procedure or treatment is generally recommended.ESGE recommends that the following should be considered to be a low risk (curative) resection and no further treatment is generally recommended: an en bloc R0 resection of a superficial GI lesion with superficial submucosal invasion (sm1), that is well to moderately differentiated, with no lymphovascular invasion, of size ≤ 20 mm for an esophageal squamous cell carcinoma or ≤ 30 mm for a stomach lesion or of any size for a BE-related or colorectal lesion, and with no lymphovascular invasion, and no budding grade 2 or 3 for colorectal lesions.ESGE recommends that, after an endoscopically complete resection, if there is a positive horizontal margin or if resection is piecemeal, but there is no submucosal invasion and no other high risk criteria are met, this should be considered a local-risk resection and endoscopic surveillance or re-treatment is recommended rather than surgery or other additional treatment.ESGE recommends that when there is a diagnosis of lymphovascular invasion, or deeper infiltration than sm1, or positive vertical margins, or undifferentiated tumor, or, for colorectal lesions, budding grade 2 or 3, this should be considered a high risk (noncurative) resection, and complete staging and strong consideration for additional treatments should be considered on an individual basis in a multidisciplinary discussion.ESGE recommends scheduled endoscopic surveillance with high definition white-light and chromoendoscopy (virtual or dye-based) with biopsies of only the suspicious areas after a curative ESD.

OverStitch devices (OverStitch and OverStitch Sx; Apollo Endosurgery, Inc, Austin, Tex, USA) are used for a wide range of applications. A European registry was created to prospectively collect technical and clinical data regarding both systems to provide procedural outcomes and to find correlation between procedural characteristics and outcomes. This study shows the initial results of the first 3 years of the registry.Patients who underwent endoscopic suturing from January 2018 to January 2021 at 9 centers were enrolled. Data regarding the disease treated,suturing pattern and outcomes were registered. Technical feasibility (success reaching the target area), technical success (success placing sutures), and clinical success (complete resolution of the clinical issue) were recorded and analyzed.During the study period, 137 patients (57.7% men) were enrolled with 100% technical feasibility rate. Endoscopic suturing was successfully performed in 136 cases (16.7% with OverStitch Sx), obtaining a technical success rate of 99.3%. No adverse events were recorded. Overall clinical success was 89%. Mucosal defects were sutured in 32 patients (100% clinical success). Leaks/fistulas were treated in 23 patients (64.7% clinical success). The clinical success of stent fixations (n = 38) was 85%. Perforations (n = 22) were repaired with a clinical success of 94.7%. No significant correlation between location, suture pattern or number, and the success was found, except in case of fistulas where fistulas 1 cm treated by a continuous suture were more likely to achieve clinical success in the follow-up (P .001).OverStitch-based suturing is technically feasible regardless of site and method of suturing, with no cases of failure. The overall technical success rate of 99.3% and the clinical outcome success rate of 89% demonstrate that OverStitch technology provides reliable suturing with clinical advantages, especially with fistulas 1 cm.

Abstract Introduction Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy (SAA) is technically challenging and associated with a significant number of failures. We examined the feasibility and efficacy of a novel technique for the management of bile duct stones (BDSs), called underwater cap-assisted ERCP (u-ERCP). Methods Between June 2019 and February 2020 all patients with SAA with jaundice or cholangitis secondary to BDSs who underwent u-ERCP were enrolled. The u-ERCP technique combines the underwater advancement of a pediatric colonoscope with a transparent cap fitted on the tip of the endoscope. We evaluated the technical success, clinical success, and adverse events associated with u-ERCP. Results We describe the technique itself and our initial experience in six patients. A complete and successful procedure was carried out in all patients, with the occurrence of no adverse events. None of the patients needed additional treatments for recurrence of symptoms during the follow-up period. Conclusions u-ERCP can be considered as a promising alternative for successful endoscopic management of biliary disease in patients with SAA.

Several studies have shown a significant adenoma miss rate up to 35% during screening colonoscopy, especially in patients with diminutive adenomas. The use of artificial intelligence (AI) in colonoscopy has been gaining popularity by helping endoscopists in polyp detection, with the aim to increase their adenoma detection rate (ADR) and polyp detection rate (PDR) in order to reduce the incidence of interval cancers. The efficacy of deep convolutional neural network (DCNN)-based AI system for polyp detection has been trained and tested in ex vivo settings such as colonoscopy still images or videos. Recent trials have evaluated the real-time efficacy of DCNN-based systems showing promising results in term of improved ADR and PDR. In this review we reported data from the preliminary ex vivo experiences and summarized the results of the initial randomized controlled trials.

Italy recorded its first case of confirmed acute respiratory illness because of coronavirus on February 18, 2020, soon after the initial reports in China. Since that time, Italy and nations throughout the world have adopted very stringent and severe measures to protect populations from spread of infection. Despite these measures, the number of infected people is growing exponentially, with a significant number of patients developing acute respiratory insufficiency. Endoscopy departments face significant risk for diffusion of respiratory diseases that can be spread via an airborne route, including aspiration of oral and fecal material via endoscopes. The purpose of this article is to discuss the measures, with specific focus on personal protection equipment and dress code modalities, implemented in our hospital to prevent further dissemination of COVID-19 infection.

ObjectiveEndoscopic submucosal dissection (ESD) in a curative intent for submucosa-invasive early (T1) colorectal cancers (T1-CRCs) often leads to subsequent surgical resection in case of histologic parameters indicating higher risk of nodal involvement. In some cases, however, the expected benefit may be offset by the surgical risks, suggesting a more conservative approach.DesignRetrospective analysis of consecutive patients with T1-CRC who underwent ESD at 13 centres ending inclusion in 2019 (n=3373). Cases with high risk of nodal involvement (non-curative ESD: G3, submucosal invasion>1000 µm, lymphovascular involvement, budding or incomplete resection/R1) were analysed if follow-up data (endoscopy/imaging) were available, regardless of the postendoscopic management (follow-up vs surgery) selected by the multidisciplinary teams in these institutions. Comorbidities were classified according to Charlson Comorbidity Index (CCI). Outcomes were disease recurrence, death and disease-related death rates in the two groups. Rate of residual disease (RD) at both the previous resection site and regional lymph nodes was assessed in the surgical cases as well as from follow-up in the follow-up group.ResultsOf 604 patients treated by colorectal ESD for submucosally invasive cancer, 207 non-curative resections (34.3%) were included (138 male; mean age 67.6±10.9 years); in 65.2% of cases, no complete resection was achieved (R1). Of the 207 cases, 60.9% (n=126; median CCI: 3; IQR: 2–4) underwent surgical treatment with RD in 19.8% (25/126), while 39.1% (n=81, median CCI: 5; IQR: 4–6) were followed up by endoscopy in all cases. Patients in the follow-up group had a higher overall mortality (HR=3.95) due to non-CRC causes (n=9, mean survival after ESD 23.7±13.7 months). During this follow-up time, tumour recurrence and disease-specific survival rates were not different between the groups (median follow-up 30 months; range: 6–105).ConclusionFollowing ESD for a lesion at high risk of RD, follow-up only may be a reasonable choice in patients at high risk for surgery. Also, endoscopic resection quality should be improved.Trial registration numberNCT03987828.

Contains fulltext : 252157.pdf (Publisher’s version ) (Open Access) BACKGROUND: Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) is emerging as a complementary therapeutic approach for pancreatic solid masses. However, results of published data are difficult to interpret because of a retrospective design and small sample size. AIM: To systematically review data on EUS-RFA for solid lesions and to pool the results of the different experiences in order to provide more consistent evidence in terms of safety and efficacy. METHODS: A comprehensive systematic literature search on the main databases was performed to identify articles in which patients with pancreatic solid lesions underwent EUS-RFA. The primary outcomes were procedure-related adverse events (AEs) and mortality. Secondary outcomes were the technical success rate and the effects on primary tumor growth. Statistical analyses were performed using Stata version 14.0. RESULTS: In total, 14 studies were included, with 120 patients undergoing 153 ablations of 129 solid pancreatic lesions. The STARmed technology was used in seven studies, the Habib system in six studies, and the HybridTherm probe in one study. The pooled technical success rate was 99.0% (I (2): 25.82%). The pooled overall AE rate was 8.0% (I (2): 11.46%). Excluding mild AEs, the pooled rates of serious AEs was 1.0% (I (2): 0%). No mortality related to the procedure was reported. CONCLUSION: The present pooled analysis confirms the safety and feasibility of EUS-RFA.

EUS-guided biliary drainage (BD) through hepaticogastrostomy (HGS) is an option in case of ERCP failure. Available data suggest that this procedure may be challenging with possible severe adverse events (AEs) mainly due to stent migration. The aim of our pilot study was to prospectively assess the technical and clinical outcomes of EUS-HGS using a new dedicated partially covered self-expandable metal stent with anti-migratory systems.This is a single-center prospective study enrolling patients with malignant biliary obstruction undergoing EUS-HGS after failed ERCP, between June 2020 and March 2021. The primary endpoint was the technical success rate. Evaluation of specific stent-related technical features as compared with commonly used self-expandable metal stent, clinical success rate, and procedure-related AEs was also assessed.Twenty-two patients (15%-68.2%, female; mean age, 66.0 ± 10.0) were enrolled in the study analysis. Different causes of ERCP failure were infiltration of papilla by neoplastic tissue (4, 18.2%), unreachable papilla for duodenal stricture (9, 40.9%), surgically altered anatomy with Roux-en-Y reconstruction (4, 18.2%), and incomplete BD after transpapillary stent placement (5, 22.7%). Technical success was achieved in all patients, in a mean procedural time of 43.3 ± 26.8 min. Technical features were graded as high or medium in all cases. The clinical success rate was 91% (20/22, mean follow-up: 10.8 ± 3.1 months). There were no cases of stent misplacement or stent migration. Three (13.6%) cases of a hepatic abscess requiring percutaneous drainage and systemic antibiotics were reported, with no impact on clinical success and following oncologic treatments. No deaths occurred.EUS-HGS with a new dedicated stent with anti-migratory systems is feasible and effective, preventing stent migration, and misplacement. Although the persistent procedural challenges, dedicated devices may contribute to outcomes improvement and procedure diffusion.

In the last decade, flexible endoscopic septotomy has been reported as a well-tolerated and effective treatment for Zenker's diverticulum. More recently, novel endoscopic submucosal tunneling techniques, namely Zenker-PerOral Endoscopic Myotomy (Z-POEM) and PerOral Endoscopic Septotomy (POES) have been proposed to obtain complete muscular septum exposure and deeper myotomy. The aim of this study is to provide a systematic review with a meta-analysis of the first experiences of third space approaches for Zenker's diverticulum. Electronic databases (Medline, Scopus, EMBASE) were searched up to October 2020. Studies including patients with symptomatic Zenker's diverticulum who underwent endoscopic treatment by submucosal tunneling technique were eligible. Procedural, clinical and safety outcomes were assessed by pooling data with a random-effect model to obtain a proportion with a 95% confidence interval. Nine retrospective studies were eligible for inclusion (196 patients). Five studies were performed in the USA, two in Europe and two in Asia. Endoscopic treatment was feasible in 96.9% (I2 = 0%) of patients. The mean procedure duration was 36.4 ± 14.3 minutes. Clinical success was achieved after 93.4% (I2 = 0%) of procedures. The overall adverse events rate was 4.9% (I2 = 0%). No differences between the two approaches (Z-POEM vs POES) have been shown in terms of both efficacy and safety. Submucosal tunneling techniques appear to be feasible for symptomatic Zenker's diverticulum, with promising results in terms of efficacy and safety outcomes.

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.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.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.The use of a standardized nomenclature provided comparable results with either of the 2 recently approved CADe systems. (Clinical trial registration number: NCT04399590.).

Introduction Multiple therapeutic modalities including surgery and rigid and flexible endoscopy have been adopted to manage Zenker's diverticulum (ZD). Minimally invasive flexible endoscopic septotomy (FES) techniques have been increasingly favored over the past 20 years; however, long-term data are still scanty. The aim of this study is to evaluate early and long-term outcomes of FES for naive ZD in a single-center setting. Methods From 2010 to 2017, ZD patients treated with FES were included in a prospectively maintained database (NCT03948438). Those who had already been treated surgically or endoscopically were excluded from the analysis. The Dakkak and Bennett dysphagia scale was used to rate the dysphagia. Persistent complete or near-complete resolution of symptoms (Dakkak and Bennett 0 or 1) was defined as clinical success. Postprocedural adverse events were reported according to ASGE lexicon. Results Overall, 256 consecutive patients were treated. Mean pouch size was 29.8 ± 11.3 mm. The procedure was successfully completed in all scheduled patients, with an early clinical success of 96.1%. Adverse events occurred in 3.5% (9/256) of patients. Eight of them were mild/moderate with no fatal events, whereas one patient required surgery. Recurrences occurred in 31.3% (80/256) of treated patients after a mean time of 9 ± 3 months and 95% of recurrences were treated by a second FES. At an average follow-up of 5.5 years, 95.3% of patients were asymptomatic after a mean number of 1.3 procedures. Discussion FES is a safe and effective treatment modality for patients with ZD. Recurrence rate is significant; however, endoscopic reintervention is associated with long-term relief of dysphagia.

Reported experience from the recent worldwide covid-19 outbreak suggests that GI endoscopy is a potential source of infection for healthcare workers (HCW); less is known about patient risk through performance of GI endoscopy as a high-risk medical procedure. Two case series from Northern Italy were recorded, one on 851 patients from one large tertiary referral centre and the other on 968 HCWs from 41 hospitals in the area. All 851 patients endoscoped in Humanitas University Hospital between 27 January and 13 March received a 2-week follow-up call; the response rate was 94.2%. Of these 802 patients, only 1 became covid-19 positive; 7 further cases developed fever and cough (3 tested negative). None of these eight cases (1.0%) required hospitalisation. In the other study, 42 hospitals in Northern Italy were invited to join a survey with regard to covid-19 positivity among HCWs, and 41 responded; centres with positive cases were interviewed in detail. Of 968 HCWs in these centres, 42 (4.3%) were tested positive for covid-19, and 6 (0.6%) had to be temporarily hospitalised (for a mean of 8 days, none on intensive care unit (ICU)). Of these 42 cases, 85.7% occurred before the introduction of safety measures, including personal protective equipment (PPE) and case selection/reduction in GI endoscopy. Clustering of HCW infection (54.7% of all cases) was observed in three centres. This data suggest that GI endoscopy appears to be relatively safe for both patients and medical personnel when using adequate protective measures. As of 31 March 2020, Italy and especially its Northern regions became the epicentre of the novel coronavirus (severe acute respiratory syndrome-CoV-2) outbreak, with more than 100 000 documented infections and a higher mortality rate than that reported in other countries. According to recent data issued by the Italian Health Authority, more than 10% of all infections in …

Background and Aims Inflammatory bowel disease is associated with an increased risk of colorectal cancer, with estimates ranging 2–18%, depending on the duration of colitis. The management of neoplasia in colitis remains controversial. Current guidelines recommend endoscopic resection if the lesion is clearly visible with distinct margins. Colectomy is recommended if complete endoscopic resection is not guaranteed. We aimed to assess the outcomes of all neoplastic endoscopic resections in inflammatory bowel disease. Methods This was a multicentre retrospective cohort study of 119 lesions of visible dysplasia in 93 patients, resected endoscopically in inflammatory bowel disease. Results A total of 6/65 [9.2%] lesions 20 mm in size were treated by EMR vs 35/51 [68.6%] by ESD. Almost all patients [97%] without fibrosis were treated by EMR, and patients with fibrosis were treated by ESD [87%], p < 0.001. In all, 49/78 [63%] lesions treated by EMR were resected en-bloc and 27/41 [65.9%] of the ESD/KAR [knife-assisted resection] cases were resected en-bloc, compared with 15/41 [36.6%] resected piecemeal. Seven recurrences occurred in the cohort. Seven complications occurred in the cohort; six were managed endoscopically and one patient with a delayed perforation underwent surgery. Conclusions Larger lesions with fibrosis are best treated by ESD, whereas smaller lesions without fibrosis are best managed by EMR. Both EMR and ESD are feasible in the management of endoscopic resections in colitis.

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 .)

Background The novel Coronavirus (SARS‐CoV‐2) has caused almost 2 million deaths worldwide. Both Food and Drug Administration and European Medicines Agency have recently approved the first COVID‐19 vaccines, and a few more are going to be approved soon. Methods Several different approaches have been used to stimulate the immune system in mounting a humoral response. As more traditional approaches are under investigation (inactivated virus vaccines, protein subunit vaccines, recombinant virus vaccines), more recent and innovative strategies have been tried (non‐replicating viral vector vaccines, RNA based vaccines, DNA based vaccines). Results Since vaccinations campaigns started in December 2020 in both the US and Europe, gastroenterologists will be one of the main sources of information regarding SARS‐CoV 2 vaccination for patients in their practice, including vulnerable patients such as those with Inflammatory Bowel Disease (IBD), patients with chronic liver disease, and GI cancer patients. Conclusions Thus, we must ourselves be well educated and updated in order to provide unambiguous counseling to these categories of vulnerable patients. In this commentary, we aim to provide a comprehensive review of both approved COVID‐19 vaccines and the ones still under development, and explore potential risks, benefits and prioritization of vaccination.

Background and aimsArtificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related to physician experience is not known. We performed a randomised trial with colonoscopists in their qualification period (AID-2) and compared these data with a previously published randomised trial in expert endoscopists (AID-1).MethodsIn this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (ResultsIn 660 patients (62.3±10 years; men/women: 330/330) with equal distribution of study parameters, overall ADR was higher in the CADe than in the control group (53.3% vs 44.5%; relative risk (RR): 1.22; 95% CI: 1.04 to 1.40; pConclusionsIn less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experience appears to play a minor role as determining factor for ADR.Trial registration numberNCT:04260321.

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.).

Background Thermal damage to the muscle layer during mucosal application of argon plasma coagulation (APC) may be avoided by creating a fluid cushion within the submucosal layer, but the minimum injection volume needed or the ideal injection fluid are yet to be established. We conducted a systematic ex vivo study with this aim. Methods All experiments were performed in an ex vivo porcine gastrointestinal tract model. Five different fluids (saline, Glyceol, Gelafundin, Voluven, and Eleview) of different volumes were injected into the submucosa of different parts of the gastrointestinal tract. APC was applied to the mucosa at different power settings. Immediately after APC treatment, the temperature was measured through a thermocouple placed inside the fluid cushion, just on top of the muscle layer. The minimum volume of fluid needed to protect the muscle layer from thermal damage was determined. Results There was no difference in the temperature measured among the different injection fluids at the surface of the muscle, in all the locations, at equal injection volumes and power settings. The minimum amounts of fluid needed to protect the muscle layer were 2 and 3 mL for power settings of 30-90 W and 90-120 W, respectively. Conclusions Normal saline and 4 commercially available submucosal injection fluids possess similar thermal protective effects. To reduce the likelihood of thermal damage to deeper layers when APC is applied, a minimum injection volume of 3 mL is recommended if less than 90 W power will be utilized over 3 sec.

Colonoscopy remains the standard strategy for screening for colorectal cancer around the world due to its efficacy in both detecting adenomatous or pre-cancerous lesions and the capacity to remove them intra-procedurally. Computer-aided detection and diagnosis (CAD), thanks to the brand new developed innovations of artificial intelligence, and especially deep-learning techniques, leads to a promising solution to human biases in performance by guarantying decision support during colonoscopy. The application of CAD on real-time colonoscopy helps increasing the adenoma detection rate, and therefore contributes to reduce the incidence of interval cancers improving the effectiveness of colonoscopy screening on critical outcome such as colorectal cancer related mortality. Furthermore, a significant reduction in costs is also expected. In addition, the assistance of the machine will lead to a reduction of the examination time and therefore an optimization of the endoscopic schedule. The aim of this opinion review is to analyze the clinical applications of CAD and artificial intelligence in colonoscopy, as it is reported in literature, addressing evidence, limitations, and future prospects.

Background and aims Granular mixed laterally spreading tumors (GM-LSTs) have an intermediate level of risk for submucosal invasive cancer (SMICs) without clear signs of invasion (covert); the optimal resection method is uncertain. We aimed to determine the risk of covert SMIC in GM-LSTs based on clinical and endoscopic factors. Methods We collected data from 693 patients (50.6% male; median age, 69 years) with colorectal GM-LSTs, without signs of invasion, who underwent endoscopic resection (74.2%) or endoscopic submucosal dissection (25.2%) at 7 centers in Italy from 2016 through 2019. We performed multivariate and univariate analyses to identify demographic and endoscopic factors associated with risk of SMIC. We developed a multivariate model to calculate the number needed to treat (NNT) to detect 1 SMIC. Results Based on pathology analysis, 66 patients (9.5%) had covert SMIC. In multivariate analyses, increased risk of covert SMIC were independently associated with increasing lesion size (odds ratio per mm increase, 1.02, 95% CI, 1.01–1.03; P = .003) and rectal location (odds ratio, 3.08; 95% CI, 1.62-5.83; P = .004). A logistic regression model based on lesion size (with a cutoff of 40 mm) and rectal location identified patients with covert SMIC with 47.0% sensitivity, 82.6% specificity, and an area under the curve of 0.69. The NNT to identify 1 patient with a nonrectal SMIC smaller than 4 cm was 20; the NNT to identify 1 patient with a rectal SMIC of 4 cm or more was 5. Conclusions In an analysis of data from 693 patients, we found the risk of covert SMIC in patients with GM-LSTs to be approximately 10%. GM-LSTs of 4 cm or more and a rectal location are high risk and should be treated by en-bloc resection. ClinicalTrials.gov , Number: NCT03836131.

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 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.

Esophagogastric junction outflow obstruction (EGJOO) is a rare but increasingly recognized diagnosis as described by The Chicago Classification of Esophageal Motility Disorders version 3.0 (version 3.0).1 On high-resolution manometry (HRM), EGJOO is characterized by increased integrated relaxation pressure (IRP) of the lower esophageal sphincter (LES), yet with some preserved esophageal peristalsis.2-4 Little consensus exists on the preferred therapeutic approach.3 Although conceptually per-oral endoscopic myotomy (POEM) should address the measurable dysfunction in the LES, few data exist to support this.5 Thus, we aimed to evaluate the safety and efficacy of POEM for the treatment of symptomatic EGJOO.

Endoscopic papillectomy (EP) is a viable therapy in ampullary lesions (AL). Many series have reported low morbidity and acceptable outcomes. We performed a systematic review with pooled analysis to assess the safety and efficacy of EP for AL. Electronic databases (Medline, Scopus and EMBASE) were searched up to September 2018. Studies that included patients with endoscopically resected AL were eligible. The rate of adverse events (AEs; primary outcome) and the rates of both technical and clinical efficacy outcomes were pooled by means of a random- or fixed-effects model to obtain a proportion with a 95% confidence interval (CI). Twenty-nine studies were included (1751 patients). The overall AE rate was 24.9%. The post-procedural pancreatitis rate was 11.9%, with the only factor affecting this outcome being prophylactic pancreatic stenting. The complete resection rate was 94.2%, with a rate of oncologically curative resection of 87.1%. The recurrence rate was 11.8% (follow-up: 9.6–84.5 months). EP is a relatively safe and effective option for AL. Our study might definitively suggest the protective role of prophylactic pancreatic stenting against post-procedural pancreatitis.

Background Treatments of Zenker’s diverticulum aim to dissect the cricopharyngeal muscle, removing the underlying source of dysfunction. This is difficult in patients with a short-septum (≤ 20 mm) diverticulum because the limited anatomical space restricts the operating area for either rigid or flexible endoscopic approaches. The aim of this study was to investigate the efficacy and safety of a novel third-space approach, peroral endoscopic septotomy (POES), for treating symptomatic patients with short-septum Zenker’s diverticulum. Methods All patients with short-septum Zenker’s diverticulum who were referred for endoscopic repair from September 2017, were considered for the study. Outcomes included procedure-related adverse events and symptom improvement. The Dakkak – Bennett score was used to quantify dysphagia. Results 20 patients (men 12, women 8; mean age 67.9 years [SD 14.3]) underwent POES. All procedures were performed with patients under deep sedation. Mean size of Zenker’s diverticulum was 17.5 mm (SD 3.0) and mean dysphagia score was 2.7 (SD 0.5). Average procedure time was 13.8 minutes (SD 5.1). No intra- or post- procedural adverse events occurred. Septal myotomy was successfully completed in all patients. Dysphagia significantly improved in 19 out of 20 patients. Dakkak – Bennett score improved to 0.3 (SD 0.5), P Conclusions POES may be considered as a potential alternative for the treatment of short-septum Zenker’s diverticulum. Further data are required to validate this technique and compare it with already available rigid and flexible approaches.

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 .)

Background and Aims EUS-guided biopsy sampling is the method of choice for obtaining pancreatic tissue. Next-generation sequencing (NGS) has been applied to EUS-guided biopsy sampling and may classify patients based on specific molecular profiles. Our study aimed to compare side-by-side the diagnostic yield achievable by genetic identification of somatic mutations detected with NGS versus histologic and cytologic typing in locally advanced pancreatic carcinoma (LAPC) in samples acquired under EUS guidance. Methods We conducted a prospective comparative pilot study at Humanitas Research Hospital. The study included 33 patients referred for LAPC who underwent EUS-guided tissue acquisition using a 22-gauge Franseen needle. Material was obtained for both pathologic diagnosis and DNA extraction and targeted NGS analysis with the AmpliSeq Comprehensive Panel v3 (Illumina Inc, San Diego, Calif, USA). Twenty-one genes were prioritized for somatic mutation detection. Results The final diagnosis was pancreatic ductal adenocarcinoma (PDAC) in all patients (100%). A macroscopic core was obtained in 30 patients (91%). In 3 lesions no cores adequate for histologic analysis were obtained, but cytologic analysis revealed tumoral cells from PDAC. DNA was extracted from 32 of 33 samples (97%), most of which (27/32) carried at least 2 clearly pathogenic mutations in different genes. Detection of K-ras mutation allowed for molecular diagnosis of PDAC in most of the patients (30/32). Conclusions In our study we demonstrated that proper tissue specimens obtained under EUS guidance allowed DNA sample extraction and subsequent NGS analysis in 97% of cases. These results support the potential role of NGS as a complementary diagnostic test to be implemented in association with standard diagnostic modalities. (Clinical trial registration number: NCT03578939 .)

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 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.

The benefits of prophylactic clipping to prevent bleeding after polypectomy are unclear. We conducted an updated meta-analysis of randomized trials to assess the efficacy of clipping in preventing bleeding after polypectomy, overall and according to polyp size and location.We searched the MEDLINE/PubMed, Embase, and Scopus databases for randomized trials that compared the effects of clipping vs not clipping to prevent bleeding after polypectomy. We performed a random-effects meta-analysis to generate pooled relative risks (RRs) with 95% CIs. Multilevel random-effects metaregression analysis was used to combine data on bleeding after polypectomy and estimate associations between rates of bleeding and polyp characteristics.We analyzed data from 9 trials, comprising 71897 colorectal lesions (22.5% 20 mm or larger; 49.2% with proximal location). Clipping, compared with no clipping, did not significantly reduce the overall risk of postpolypectomy bleeding (2.2% with clipping vs 3.3% with no clipping; RR, 0.69; 95% confidence interval [CI], 0.45-1.08; P = .072). Clipping significantly reduced risk of bleeding after removal of polyps that were 20 mm or larger (4.3% had bleeding after clipping vs 7.6% had bleeding with no clipping; RR, 0.51; 95% CI, 0.33-0.78; P = .020) or that were in a proximal location (3.0% had bleeding after clipping vs 6.2% had bleeding with no clipping; RR, 0.53; 95% CI, 0.35-0.81; P.001). In multilevel metaregression analysis that adjusted for polyp size and location, prophylactic clipping was significantly associated with reduced risk of bleeding after removal of large proximal polyps (RR, 0.37; 95% CI, 0.22-0.61; P = .021) but not small proximal lesions (RR, 0.88; 95% CI, 0.48-1.62; P = .581).In a meta-analysis of randomized trials, we found that routine use of prophylactic clipping does not reduce risk of postpolypectomy bleeding overall. However, clipping appeared to reduce bleeding after removal of large (more than 20 mm) proximal lesions.

Background The recently introduced Hot AXIOS™ system for endoscopic ultrasound (EUS)-guided transenteric drainage has the potential to change interventional endoscopy significantly. The aim of our study was to assess the effectiveness and safety of this new type of lumen-apposing metal stent (LAMS) with cautery system for pancreatic collection, and gallbladder and biliary tree drainage. Methods We retrospectively reviewed consecutive patients undergoing EUS-guided drainage by LAMS with cautery system in a tertiary-care academic medical center between March 2014 and March 2017. All patients were included in our prospectively maintained institutional EUS database. The main outcome measures were technical success, clinical effectiveness, and adverse events. Results A total of 45 patients (20 men, mean age 69.6 years) underwent LAMS placement. Indications were pancreatic fluid collections (19 patients, 42.2%), acute cholecystitis (10 patients, 22.2%), and biliary drainage (16 patients, 35.5%). Technical success was achieved in all patients except one (97.7%). Clinical success was achieved in 86.4% (38/44) of cases and adverse events occurred in 5 (11.4%) of patients. Conclusions In our experience, EUS-guided LAMS placement performed by expert endoscopists was feasible and effective in the endoscopic management of pancreatic fluid collection, and biliary and gallbladder drainage. Optimization of transmural drainage by new dedicated devices could improve efficacy and safety in appropriately selected patients.