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01 april 2023, Item does not contain fulltext, BACKGROUND: Current surveillance for Barrett's esophagus (BE), consisting of four-quadrant random forceps biopsies (FBs), has an inherent risk of sampling error. Wide-area transepithelial sampling (WATS) may increase detection of high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC). In this multicenter randomized trial, we aimed to evaluate WATS as a substitute for FB. METHODS: Patients with known BE and a recent history of dysplasia, without visible lesions, at 17 hospitals were randomized to receive either WATS followed by FB or vice versa. All WATS samples were examined, with computer assistance, by at least two experienced pathologists at the CDx Diagnostics laboratory. Similarly, all FBs were examined by two expert pathologists. The primary end point was concordance/discordance for detection of HGD/EAC between the two techniques. RESULTS: 172 patients were included, of whom 21 had HGD/EAC detected by both modalities, 18 had HGD/EAC detected by WATS but missed by FB, and 12 were detected by FB but missed by WATS. The detection rate of HGD/EAC did not differ between WATS and FB (P = 0.36). Using WATS as an adjunct to FB significantly increased the detection of HGD/EAC vs. FB alone (absolute increase 10 % [95 %CI 6 % to 16 %]). Mean procedural times in minutes for FB alone, WATS alone, and the combination were 6.6 (95 %CI 5.9 to 7.1), 4.9 (95 %CI 4.1 to 5.4), and 11.2 (95 %CI 10.5 to 14.0), respectively. CONCLUSIONS: Although the combination of WATS and FB increases dysplasia detection in a population of BE patients enriched for dysplasia, we did not find a statistically significant difference between WATS and FB for the detection of HGD/EAC as single modality.

Objective: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is the first-line technique for the sampling of pancreatic lesions. Many factors can influence the diagnostic performance of this procedure, including the use of rapid on-site evaluation (ROSE). The primary aim of this study was to compare the adequacy, diagnostic yield, accuracy, sensitivity and specificity of EUS-FNA for solid pancreatic lesions before and after the introduction of ROSE. Methods: This retrospective single-centre study evaluated all consecutive patients who underwent EUS-FNA for suspicious, solid pancreatic masses from April 2012 to March 2015. We compared the findings of EUS-FNA procedures performed during the first and second years following the adoption of ROSE (“ROSE1” and “ROSE2”, respectively) to those performed the year before ROSE introduction (the “pre-ROSE” group). Results: Ninety-one consecutive patients with a total of 93 pancreatic lesions were enrolled. For the pre-ROSE, ROSE1 and ROSE2 groups, the adequacy rates were 96.2%, 96.6% and 100%, the diagnostic yield values were 76.9%, 89.7% and 92.1% and accuracy values were 69.2%, 86.2% and 89.5% (p = NS). Sensitivity for malignancy improved from 63.7% in the pre-ROSE group to 91.7% and 91.2% in the post-ROSE groups (p < 0.05). Specificity for malignancy was 100% in all groups. Conclusions: ROSE can improve the diagnostic performance of EUS-FNA for solid pancreatic lesions, although only sensitivity reached statistical significance.

Background and aims Artificial 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). Methods In this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (<2000 colonoscopies) performed screening/surveillance/diagnostic colonoscopies in consecutive 40-80 year-old subjects using high-definition colonoscopy with or without a real-time deep-learning computer-aided detection (CADe) (GI Genius, Medtronic). The primary outcome was ADR in both groups with histology of resected lesions as reference. In a post-hoc analysis, data from this randomised controlled trial (RCT) were compared with data from the previous AID-1 RCT involving six experienced endoscopists in an otherwise similar setting. Results In 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; p<0.01 for non-inferiority and p=0.02 for superiority). Similar increases were seen in adenoma numbers per colonoscopy and in small and distal lesions. No differences were observed with regards to detection of non-neoplastic lesions. When pooling these data with those from the AID-1 study, use of CADe (RR 1.29; 95% CI: 1.16 to 1.42) and colonoscopy indication, but not the level of examiner experience (RR 1.02; 95% CI: 0.89 to 1.16) were associated with ADR differences in a multivariate analysis. Conclusions In less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experien

Background Ischemic colitis (IC) is caused by a transient hypo-perfusion of the colon leading to mucosal ulcerations, inflammation, and hemorrhage. The primary aim was to identify predictive factors of endoscopic severity of IC. Secondary endpoints were to show epidemiology, clinical presentation, endoscopic findings, and outcomes of IC. Methods In this single-center retrospective analysis, IC was scored according to endoscopy as: grade 1 (hyperemia, <1 cm erosions and non-confluent ulcers); grade 2 (>1 cm superficial, partially confluent ulcers); and grade 3 (deep or diffuse ulcers or necrosis). Then, IC was grouped into low-(grade 1) and high-grade (grades 2 and 3). Significant (P≤0.1) independent factor of severe IC at univariate analysis were entered into multivariate analysis and considered significant at P<0.05. Results 227 patients (male:female 60:167; mean age 72.7±16.2 years) were included. IC was scored as grade 1 in 137/227 (60.4%), grade 2 in 62/227 (27.3%), and grade 3 in 28/227 (12.3%) patients. At univariate analysis, age (74.9 vs. 71.3 years; P=0.09), diabetes (14.4% vs. 12.4%; P=0.09), and leukocytosis or creatinine elevation (74.4% vs. 60.6%; P=0.032) were associated with endoscopic high-grade IC. At multivariate analysis, leukocytosis and creatinine levels remained associated with high-grade IC (44.7% vs. 29.9%; odds ratio 1.92, 95% confidence interval 1.07-3.52; P=0.030). Conclusions Although confounding factors cannot be excluded due to study design and patients’ characteristics, leukocytosis and/or creatinine elevation at hospital admission were significantly related with endoscopic high-grade IC and might be used to stratify patients for the need of endoscopy.

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.)

School-based PE programs are poor nationwide and they need to be potentiated against a rising prevalence of chronic diseases and physical inactivity. Our aim was to evaluate the effectiveness of 40 versus 20 physical education (PE) classes on physical fitness of a cohort of northwestern Italian primary schoolchildren. Methods: 5751 schoolchildren aged 6–11years were studied between November 2017 and May 2018 from 25 primary schools of Lombardy. Pupils underwent either a control group (CON, # = 2553; $ = 2864) or an experimental group (PLUS, # = 158; $ = 176) in which they attended 20 or 40 PE classes, respectively. Sixty-minute classes were delivered once a week (CON) or biweekly (PLUS) by qualified PE teaching assistants through an approximate school semester. Anthropometrics, cardiorespiratory (six-minute walking test, 6MWT), musculoskeletal (standing broad jump, SBJ) and motor fitness (4 9 10 m shuttle run test, SRT) were evaluated at baseline and upon completion of the study. Wilcoxon matched-pairs signed rank test was performed. Results: At the end of the study, PLUS group revealed a better dis- tribution of BMI categories (under weight UW Dpost–pre = - 5.4%; normal weight NW Dpost–pre = ? 8.9%; overweight OW Dpost–pre = - 3.6%) compared to controls (UW Dpost–pre = - 0.4%; NW Dpost– pre = ? 1.6%; OW Dpost–pre = - 1%). PLUS children improved almost all fitness performances by a greater extent (6MWT: pre 606.8 ± 104/post 644.5 ± 93.5 m, p \ 0.0001; SBJ: pre 119.1 ± 25.3/post 124.8 ± 25.9 cm, p \ 0.0001; SRT: pre 14.9 ± 2.5/post 13.8 ± 1.9 s, p \ 0.0001) with respect to CON children (6MWT: pre 611.4 ± 102.1/post 623.6 ± 92.4 m, p \ 0.0001; SBJ: pre 116.8 ± 25.3/post 123.4 ± 24 cm, p \ 0.02; SRT: pre 14.8 ± 2.4/post 14.3 ± 2 s, p \ 0.0001). Means and SD. Conclusions: This design confirms the need to implement well- structured, school-based PE programs. Particularly, higher frequency of PE classes is advocated in order to ameliorate health-related physical fitness c

PURPOSE: To assess the effect of computer-aided detection (CAD) as a second reader on the sensitivity and specificity of computed tomographic (CT) colonography in detecting 6-9-mm colorectal cancer (CRC) lesions. MATERIALS AND METHODS: Individuals with clinical indications for colonoscopy--either for symptoms or as part of participating in a surveillance program or CRC screening--were prospectively enrolled at one of 10 academic centers between July 2007 and May 2009. Institutional review board approval was obtained at each clinical site, and all participants provided written informed consent. All participants underwent CT colonography and colonoscopy on the same day. Experienced readers interpreted the CT colonography images unassisted and then reviewed all colorectal lesion-like structures pinpointed by the CAD algorithm. Segmental unblinding of CT colonoscopy findings at colonoscopy was utilized. The sensitivity and specificity of unassisted and CAD-assisted reading in identifying individuals with 6-9-mm lesions were calculated and compared by means of pairwise analysis. RESULTS: A total of 618 participants (mean age, 57.9 years; 54.5% male) were included in the final analysis. Of these participants, 464 (75.1%) had no lesions 6 mm or larger, and 52 (8.4%) had 6-9-mm lesions. The sensitivity of CT colonography with unassisted reading and that with CAD-assisted reading in identifying individuals with 6-9-mm lesions was 65.4% (95% confidence interval [CI]: 50.9%, 78.0%) and 76.9% (95% CI: 63.2%, 87.5%; P = .016), respectively. No significant change in specificity was observed: The specificity of CT colonography with unassisted and that with CAD-assisted reading was 91.8% (95% CI: 88.9%, 94.1%) and 90.9% (95% CI: 88.0%, 93.4%; P = .063), respectively. Evaluation of CAD candidates required an additional 1.6 minutes (25th-75th percentile: 1.0 minute to 3.4 minutes). CONCLUSION: The addition of CAD to reading performed by experienced readers resulted in a significant b

Objective: To assess the efficacy and safety of endoscopic resection of large colorectal polyps. Design: Relevant publications were identified in MEDLINE/EMBASE/Cochrane Central Register for the period 1966-2014. Studies in which =20 mm colorectal neoplastic lesions were treated with endoscopic resection were included. Rates of postendoscopic resection surgery due to non-curative resection or adverse events, as well as the rates of complete endoscopic removal, invasive cancer, adverse events, recurrence and mortality, were extracted. Study quality was ascertained according to Newcastle-Ottawa Scale. Forest plot was produced based on random effect models. I2 statistic was used to describe the variation across studies due to heterogeneity. Meta-regression analysis was also performed. Results: 50 studies including 6442 patients and 6779 large polyps were included in the analyses. Overall, 503 out of 6442 patients (pooled rate: 8%, 95% CI 7% to 10%, I2=78.6%) underwent surgery due to non-curative endoscopic resection, and 31/6442 (pooled rate: 1%, 95% CI 0.7% to 1.4%, I2=0%) to adverse events. Invasive cancer at histology, non-curative endoscopic resection, synchronous lesions and recurrence accounted for 58%, 28%, 2.2% and 5.9% of all the surgeries, respectively. Endoscopic perforation occurred in 96/6595 (1.5%, 95% CI 1.2% to 1.7%) polyps, while bleeding in 423/6474 (6.5%, 95% CI 5.9% to 7.1%). Overall, 5334 patients entered in surveillance, 502/5836 (8.6%, 95% CI 7.9% to 9.3%) being lost at follow-up. Endoscopic recurrence was detected in 735/5334 patients (13.8%, 95% CI 12.9% to 14.7%), being an invasive cancer in 14/5334 (0.3%, 95% CI 0.1% to 0.4%). Endoscopic treatment was successful in 664/735 cases (90.3%, 95% CI 88.2% to 92.5%). Mortality related with management of large polyps was reported in 5/6278 cases (0.08%, 95% CI 0.01% to 0.15%). Conclusions: Endoscopic resection of large polyps appeared to be an extremely effective and safe intervention. However, an ad

Accuracy and inter-observer agreement of the ProcoreTM 25 gauge needle for endoscopic ultrasound-guided tissue core biopsy.