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Background and Aims: Studies assessing EUS-guided biliary drainage (EUS-BD) or gallbladder drainage (EUS-GB) using lumen-apposing metal stents (LAMSs) have shown variable results based on the type of LAMS. We performed a meta-analysis of the available data., Methods: Multiple online databases were searched for studies using LAMSs (Axios [Boston Scientific, Marlborough, Mass, USA] or Spaxus [Taewoong Medical Co, Gimpo, Korea]) for EUS-BD and EUS-GB. The outcomes of interest were technical success, clinical success, and adverse events. Pooled proportions along with 95% confidence intervals were calculated., Results: A total of 18 observational studies were included: 11 for the Axios stent (433 patients; mean age, 72 years; 54% male) and 7 for the Spaxus stent (242 patients; mean age, 74 years; 50% male). The respective pooled outcomes for the Axios stent (EUS-BD and EUS-GB, respectively) were technical success, 96.2% and 96.2%; clinical success, 92.8% and 92.7%; total adverse events, 10.1% and 23.6%; and bleeding, 3.7% and 4.8%. The respective pooled outcomes for the Spaxus stent (EUS-BD and EUS-GB, respectively) were technical success, 93.8% and 95.9%; clinical success, 90.1% and 94.2%; total adverse events, 12.6% and 9.5%; and bleeding, 3.1% and 1.8%., Conclusions: Axios and Spaxus stents demonstrate similar pooled technical and clinical success rates. Adverse events occurred in 23.6% of patients (Axios stent) and 9.5% of patients (Spaxus stent) during EUS-GB., Competing Interests: Disclosure The following authors disclosed financial relationships: N. Sharma: Consultant for Boston Scientific, Olympus, Medtronic, and Mauna Kea; advisory board for Endoscopy Now. D. G. Adler: Consultant for Boston Scientific. All other authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Effect of underwater endoscopic submucosal dissection (UESD) on clinical outcomes as compared with conventional ESD (CESD) remains unclear. We conducted a meta-analysis of the available data., Methods: Online databases were searched for studies comparing UESD with CESD for colorectal lesions. The outcomes of interest were en-bloc resection, R0 resection, procedure time (minutes), dissection speed (mm 2 /min), and adverse events. Pooled odds ratios (ORs) and standardized mean difference (SMD), along with 95% confidence intervals (CIs) were calculated., Results: Seven studies with 1401 patients (UESD, 452; CESD, 949) were included. Mean patient age was 69 years, and 57% of patients were men. UESD had both a shorter procedure time (SMD, -1.33; 95% CI, -2.34 to -.32; P = .010) and greater dissection speed (SMD, 1.01; 95% CI, .35-1.68; P = .003) when compared with CESD. No significant differences were observed between the 2 groups with respect to en-bloc resection (OR, 1.13; 95% CI, .37-3.41), R0 resection (OR, 2.36; 95% CI, .79-7.05), delayed bleeding (OR, 1.34; 95% CI, .65-2.74), perforation (OR, 1.13; 95% CI, .64-2.00), and postresection electrocoagulation syndrome (OR, .38; 95% CI, .10-1.42)., Conclusions: UESD was faster in patients with colorectal lesions but had comparable rates of en-bloc resection, R0 resection, and adverse events when compared with CESD., Competing Interests: Disclosure The following authors disclosed financial relationships: N. Sharma: Consultant for Boston Scientific, Olympus, Medtronic, and Mauna Kea; advisory board for Endoscopy Now. D. G. Adler: Consultant for Boston Scientific. All other authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Gastric peroral endoscopic myotomy (G-POEM) is an emerging treatment for refractory gastroparesis. Although its efficacy and safety have been analyzed in previous systematic reviews and meta-analyses, no studies have compared its effectiveness based on etiology. Our study aims to evaluate the efficacy and safety of G-POEM by etiologies of gastroparesis., Methods: We conducted a comprehensive search in major databases until October 2023, focusing on the efficacy and safety of G-POEM by etiology. Our primary outcome was clinical success based on etiology, with an additional subgroup analysis on Gastroparesis Cardinal Symptom Index (GCSI) scores before and after G-POEM based on etiology using standard meta-analysis methods and the random-effects model. Heterogeneity was assessed using I 2 statistics., Results: In our analysis of 15 studies (7 retrospective, 8 prospective) involving 982 patients (mean patient age, 50.81 years; mean follow-up, 21 months), postsurgical conditions were the most common etiology in G-POEM (290 cases), followed by idiopathic factors (287 cases) and diabetes (286 cases). Subgroup analysis revealed pooled clinical success rates of 65% (95% confidence interval [CI], 51-77; I 2  = 46%) for diabetes, 70% (95% CI, 46-86; I 2  = 73%) for postsurgical conditions, and 60% (95% CI, 41-77; I 2  = 68%) for idiopathic etiologies. Our research also indicated that G-POEM significantly improved GCSI scores: 1.7 (95% CI, -.01 to 3.5; P = .052) for diabetes, 1.34 (95% CI, -.07 to 2.62; P = .038) for postsurgical conditions, and 1.5 (95% CI, .36-2.75; P = .01) for idiopathic patients., Conclusions: Based on this meta-analysis, G-POEM is effective and safe for treating refractory gastroparesis irrespective of the etiology, with significant improvements in clinical success rates and GCSI scores., Competing Interests: Disclosure The following author disclosed financial relationships: D. G. Adler: Consultant for Boston Scientific. All other authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Disclosure The following author disclosed financial relationships: D. G. Adler: Speaker and consultant for Cook Endoscopy.

Background and Aims: EUS-guided gallbladder drainage using lumen-apposing metal stents (EUS-GBD-LAMSs) and percutaneous cholecystostomy for gallbladder drainage (PTGBD) are the alternative treatment modalities in high-risk surgical patients with acute cholecystitis (AC). The aim of this study was to compare the safety of these procedures for AC in surgically suboptimal candidates., Methods: Six studies compared the 2 groups' early, delayed, and overall adverse events; they also compared length of hospital stay, re-interventions, and re-admissions rate. A random effect model calculated odds ratios (ORs) with a 95% confidence interval (CI)., Results: The 2 groups had similar early adverse events; however, EUS-GBD-LAMS was associated with a lower rate of delayed (OR, .21; 95% CI, .07-.61; P ≤ .01) and overall (OR, .43; 95% CI, .30-.61; P ≤ .01) adverse events. Patients with EUS-GBD-LAMSs had a shorter hospital stay than PTGBD., Conclusions: EUS-GBD-LAMS is a safer option than PTGBD and is associated with a shorter hospital stay in nonsurgical candidates with AC., Competing Interests: Disclosure The following author disclosed financial relationships: D. G. Adler: consultant for Boston Scientific. 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 current standard of practice is to use a duodenoscope for the evaluation of the major duodenal papilla (MDP). Recently, cap-assisted endoscopy (CAE), which uses a transparent cap at the tip of a standard front-viewing endoscope, has emerged as an alternative., Methods: A systematic literature search was performed in several databases from inception to January 2023 to identify studies evaluating the efficacy of CAE for the evaluation of the MDP., Results: Nine studies including 806 patients met our inclusion criteria. The pooled rate of technical success for CAE was 93.2% (95% confidence interval, 85.6-96.9; I 2  = 84.6%). A subgroup analysis comparing CAE with a standard endoscope showed higher odds for the evaluation of the MDP with CAE (but not a duodenoscope, which was better than CAE) with an odds ratio of 57.294 (95% confidence interval, 17.767-184.755; I 2  = 45.303%)., Conclusions: CAE offers a significant advantage with high rates of complete MDP evaluation compared with standard forward-viewing endoscopy. However, CAE is associated with lower rates of success when compared with side-viewing endoscopes., Competing Interests: Disclosure All authors disclosed no financial relationships., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Disclosure The author disclosed no financial relationships.

Background and Aims: Reintervention after endoscopic sleeve gastroplasty (ESG) can be indicated because of postprocedural adverse events from various preinterventional or postprocedural comorbidities. We developed and internally validated an ESG reintervention score (ESG-RS) that determines the individualized risk of reintervention within the first 30 days after ESG., Methods: We used data from a sample of 3583 patients who underwent ESG in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program database (2016-2021). The least absolute shrinkage and selection operator (LASSO)-penalized regression was used to select the most promising predictors of reintervention after ESG within 30 days. The predictive variables extracted by LASSO regression were entered into multivariate analysis to generate an ESG-RS by using the coefficients of the statistically significant variables. The model performance was assessed using receiver-operator curves by 10-fold cross-validation., Results: Eleven variables were selected by LASSO regression and used in the final multivariate analysis. The ESG-RS was inferred using 5 factors (history of previous foregut surgery, preoperative anticoagulation use, female gender, American Society of Anesthesiologists class ≥II, and hypertension) weighted by their regression coefficients in the multivariable logistic regression model. The area under the curve of the ESG-RS was .74 (95% confidence interval, .70-.78). For the ESG-RS, the optimal cutpoint was 67.9 (high risk vs low risk), with a sensitivity of .76 and specificity of .71., Conclusions: The ESG-RS aids clinicians in preoperative risk stratification of patients undergoing ESG while clarifying factors contributing to a higher risk of reintervention., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The practices for resection of diminutive colon polyps vary among endoscopists, and U.S. Multi-Society Task force guidelines recommend use of cold snare polypectomy (CSP) for this purpose. In this meta-analysis, we compared CSP and cold forceps polypectomy (CFP) for resection of diminutive polyps., Methods: Several databases were reviewed to identify randomized controlled trials that compared CSP and CFP for resection of diminutive polyps. The study outcomes of interest were complete resection of all diminutive polyps, complete resection of polyps ≤3 mm in size, failure of tissue retrieval, and polypectomy time. For categorical variables, pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated; for continuous variables, mean differences (MDs) with 95% CIs were calculated. Data were analyzed by using a random-effects model, and heterogeneity was assessed by using the I 2 statistic., Results: We included 9 studies with 1037 patients. Rate of complete resection of all diminutive polyps was significantly higher in the CSP group (OR, 1.68; 95% CI, 1.09-2.58). Subgroup analysis, including jumbo or large-capacity forceps, found no significant difference in complete resection between groups (OR, 1.43; 95% CI, .80-2.56). We found no significant between-groups in the rates of complete resection of polyps ≤3 mm in size (OR, .83; 95% CI, .30-2.31). Rate of failure of tissue retrieval was significantly higher in the CSP group (OR, 10.13; 95% CI, 2.29-44.74). No significant between-group difference was noted in polypectomy time., Conclusions: CFP using large-capacity or jumbo biopsy forceps is noninferior to CSP for complete resection of diminutive polyps., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: GI bleeding after ERCP is a serious adverse event and most commonly occurs after endoscopic biliary and/or pancreatic sphincterotomy. Although the strength of available evidence for post-sphincterotomy GI bleeding risk is high for therapeutic warfarin and heparin, it remains unknown for antiplatelet agents like clopidogrel and prasugrel. We conducted a retrospective United States-based, propensity-matched cohort study to assess the risk of post-sphincterotomy bleeding in patients receiving anticoagulant (AC) and antiplatelet (APT) therapy., Methods: We analyzed the U.S. Collaborative Network in the TriNetX platform through December 27, 2022, to include patients receiving APT and AC therapy who underwent ERCP within 7 days of hospitalization. One-to-one propensity score matching was performed. The primary outcome was the incidence of GI bleeding within 7 days of sphincterotomy. Secondary outcomes included need for blood transfusion, intensive care unit care, and all-cause mortality within 30 days of bleeding., Results: Overall, 2806 patients (1806 in the AC cohort and 1000 in the APT cohort) underwent ERCP with sphincterotomy. One-to-one propensity score matching was performed for age, body mass index ≥30 kg/m 2 , gender, race, ethnicity, diabetes mellitus, nicotine dependence, presence and severity of chronic kidney disease, cirrhosis, and thrombocytopenia between the cohorts. Patients in both cohorts had an increased risk of post-sphincterotomy bleeding compared with matched control subjects (adjusted odds ratios of 3.6 [95% confidence interval, 2.58-5.06] and 2.2 [95% confidence interval, 1.43-3.56], respectively). Although heparin bridging therapy and concurrent use of aspirin did not further increase the risk of GI bleeding, resumption of AC within 24 hours' postprocedure did. Neither cohort of patients was at an increased risk for blood transfusion, intensive care unit care, or all-cause mortality., Conclusions: Our database analysis shows that patients receiving AC and APT therapy are at a higher risk of post-sphincterotomy bleeding compared with matched control subjects. An appropriate drug cessation period or alternative biliary decompression modalities may be used in these patients., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: A histologic diagnosis of GI subepithelial tumors (SETs) is important because of the malignant potential of these lesions. The current modalities of choice, including EUS-guided FNA and biopsy (EUS-FNA/FNB) have demonstrated suboptimal diagnostic success. Single-incision with needle-knife (SINK) biopsy has emerged as an alternative diagnostic approach to increase tissue acquisition and diagnostic success. The aim of this study was to perform a systematic review and meta-analysis to evaluate the technical success, diagnostic success, and adverse events of SINK biopsy., Methods: We searched multiple databases including PubMed, EMBASE, CINAHL, Cochrane, Web of Science, and Google Scholar from inception to July 2022. The primary outcomes assessed were the technical success and diagnostic success of SINK in GI SETs. The secondary outcomes assessed were adverse events and whether immunohistochemical analysis could be successfully performed on tissue samples obtained via SINK., Results: Seven studies with a total of 219 SINK biopsy procedures were included in this meta-analysis. The technical success rate was 98.1% (95% CI, 94.9%-99.3%; P = .000; I 2  = .0%), and the diagnostic success rate was 87.9% (95% CI, 82.6%-91.7%; P = .000; I 2  = .0%). The immunohistochemical success rate was 88.3% (95% CI, 78.7%-93.9%; P = .000; I 2  = 3.5%). The rate of adverse events was 7.5% (95% CI, 4.3%-12.7%; P = .00; I 2  = 7.2%), and bleeding was the most common adverse event., Conclusion: SINK biopsy is a safe diagnostic procedure with a high technical and diagnostic success in patients with GI SET. Further randomized controlled trials and direct comparison studies are needed to validate these findings., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Previous studies have demonstrated that the ideal time for drainage of walled-off pancreatic fluid collections is 4 to 6 weeks after their development. However, some pancreatic collections, notably infected pancreatic fluid collections, require earlier drainage. Nevertheless, the optimal timing of the first intervention is unclear, and consensus data are sparse. The aim of this study was to evaluate the clinical efficacy and safety of EUS-guided drainage of pancreatic fluid collections <4 weeks after development compared with ≥4 weeks after development., Methods: Search strategies were developed for PubMed, Embase, and Cochrane Library databases from inception. Outcomes of interest were technical success, defined as successful endoscopic placement of a lumen-apposing metal stent; clinical success, defined as a reduction in cystic collection size; and procedure-related adverse events. A random-effects model was used for analysis, and results are expressed as odds ratio (OR) with 95% confidence interval (CI)., Results: Six studies (630 patients) were included in our final analysis, in which 182 patients (28.9%) were enrolled in the early drainage cohort and 448 patients (71.1%) in the standard drainage cohort. The mean fluid collection size was 143.4 ± 18.8 mm for the early cohort versus 128 ± 19.7 mm for the standard cohort. Overall, technical success was equal in both cohorts. Clinical success did not favor either standard drainage or early drainage (OR, .39; 95% CI, .13-1.22; P = .11). No statistically significant differences were found in overall adverse events (OR, 1.67; 95% CI, .63-4.45; P = .31) or mortality (OR, 1.14; 95% CI, .29-4.48; P = .85). Hospital stay was longer for patients undergoing early drainage compared with standard drainage (23.7 vs 16.0 days, respectively)., Conclusions: Both early (<4 weeks) and standard (≥4 weeks) drainage of walled-off pancreatic fluid collections offer similar technical and clinical outcomes. Patients requiring endoscopic drainage should not be delayed for 4 weeks., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Duodenal stents are widely used to treat patients with malignant gastric outlet obstruction (MGOO), most commonly from pancreatic cancer. The WallFlex (Boston Scientific, Natick, Mass, USA) and Evolution (Cook Endoscopy, Winston-Salem, NC, USA) duodenal stents are in widespread use for treating MGOO. The objective of this study was to analyze device failures and patient-related adverse events reported to the U.S. Food and Drug Administration (FDA) for these 2 stents., Methods: We analyzed postmarketing surveillance data on the WallFlex and Evolution duodenal stents from January 2000 to January 2022 through the FDA's Manufacturer and User Facility Device Experience (MAUDE) database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm)., Results: One hundred fifty-four MAUDE reports were identified and analyzed, from which 176 device failures and 186 patient-related adverse events were identified. Device-related failures for the WallFlex stent were delivery system failure (15.4%) and failure to activate the stent (13.2%). Device failures for the Evolution stent were failure to activate the stent (16.5%) and delivery system failure (15.3%). Patient-related adverse events for the WallFlex stent were perforation (18.9%), death (6.6%), and hemorrhage (3.8%), whereas patient-related adverse events for the Evolution duodenal stent were obstruction (16.3%), perforation (6.3%), aspiration (3.8%), and fragments of broken delivery system left in the patient (3.8%)., Conclusions: Both stents are associated with device failures such as failure to activate the stent, stent migration, and occlusion by tumor growth. Despite high success rates, duodenal stents can be associated with serious device failures and patient-related adverse events., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Despite advances in endoscopic therapies, malignancy-related GI bleeding remains difficult to manage with high rates of treatment failure and rebleeding. Topical hemostatic agents (THAs) are easier to apply to the wide bleeding surface of tumors. We conducted this systematic review and meta-analysis to evaluate the efficacy of THAs in malignancy-related GI bleeding., Methods: We conducted a comprehensive search of multiple electronic databases to identify studies reporting on the use of THAs in malignancy-related GI bleeding. The primary outcome was the achievement of hemostasis; secondary outcomes were early rebleeding (≤3 days), delayed rebleeding (>3 days), aggregate rebleeding, all-cause mortality, and GI bleeding-related mortality. A meta-analysis of proportions was done for all outcomes., Results: Out of 355 citations, 16 studies with 530 patients were included. Primary hemostasis was achieved in 94.1% (95% confidence interval [CI], 91.5-96.0). Early rebleeding was seen in 13.9% (95% CI, 9.7-19.4) and delayed rebleeding in 11.4% (95% CI, 5.8-21.1). Aggregate rebleeding was seen in 24.2% (95% CI, 18.5-31.0). All-cause mortality was 33.1% (95% CI, 23.7-44.0), whereas GI bleeding-related mortality occurred in 5.9% (95% CI, 2.2%-14.8)., Conclusions: THAs are highly effective for achieving primary hemostasis in malignancy-related GI bleeding. It should be considered as an alternative to traditional endotherapy methods in malignancy-related GI bleeding. Future studies should be designed to evaluate its efficacy and safety as a primary method of hemostasis as compared with traditional endotherapy measures., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Assessment of EUS-guided fine-needle tissue acquisition by macroscopic on-site evaluation (MOSE) is gathering attention. Studies report good diagnostic parameters with MOSE; however, the overall data are limited. We conducted this systematic review and meta-analysis to report on the pooled diagnostic assessment parameters of EUS-guided tissue acquisition by MOSE using fine-needle biopsy sampling (FNB)., Methods: Multiple databases were searched (from inception to December 2021), and studies that reported on the diagnostic assessment of EUS-guided tissue acquisition by MOSE were selected. Pooled diagnostic accuracy, sensitivity, specificity, and positive and negative predictive values were calculated by standard meta-analysis methods following the random-effects model. Heterogeneity was assessed by I 2 statistics., Results: Fourteen studies were included in the analysis, and 1508 lesions were biopsy sampled in 1489 patients undergoing EUS-guided tissue acquisition. MOSE definition included a visible core of tissue with opacity and "wormlike" features of adequate size and length (≥4 mm). The pooled accuracy of FNA and/or FNB specimens in yielding a pathologic diagnosis by MOSE was 91.3% (95% confidence interval [CI], 88.6-93.3; I 2  = 66%), pooled sensitivity was 91.5% (95% CI, 88.6-93.6; I 2  = 66%), pooled specificity was 98.9% (95% CI, 96.6-99.7; I 2  = 80%), pooled positive predictive value was 98.8% (95% CI, 97.4-99.5; I 2  = 33%), and pooled negative predictive value was 55.5% (95% CI, 46.9-63.9; I 2  = 95%). Subgroup analyses by newer-generation FNB needles demonstrated similar pooled rates, with minimal adverse events (2.5%; 95% CI, 1.5-3.9; I 2  = 21%)., Conclusions: Excellent pooled diagnostic accuracy parameters were demonstrated in EUS-guided tissue acquisition by FNB using the MOSE method., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Mechanical lithotripsy is a commonly used, effective method for fragmenting large biliary or pancreatic duct stones. Real-world data on the most commonly reported adverse events and modes of failure associated with mechanical lithotripters are limited. We analyzed the postmarketing surveillance data from the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database for 3 commercially available mechanical lithotripters for use during ERCP., Methods: A search of the MAUDE database from January 2010 to October 2021 was conducted for the following mechanical lithotripters: Trapezoid RX (Boston Scientific, Natick, Mass, USA), LithoCrush (Olympus Endoscopy, Center Valley, Pa, USA), and the Fusion Lithotripsy Extraction Basket (Cook Endoscopy, Winston Salem, NC, USA). Results were compiled and reviewed., Results: In total, 1128 medical device reports with 2129 device malfunctions and 205 patient adverse events were identified. Most device malfunctions were because of guidewire port or sheath failure (n = 379, 17.8%), basket entrapment (n = 357, 16.8%), and basket tip separation failure (n = 315, 14.8%). The most commonly reported adverse events to patients were an additional procedure to remove an entrapped basket (170/205, 82.9%), bleeding (15/205, 7.3%), and bowel perforation (5/205, 2.4%)., Conclusions: Findings from the MAUDE database highlight device- and patient-related adverse outcomes that should be recognized to improve clinical success and reduce patient risk., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Current adenoma detection rate (ADR) benchmarks for colonoscopy in individuals positive for a fecal immunochemical test (FIT) are ≥45% in men and ≥35% in women. These are based on weak, low-quality evidence. We performed a meta-analysis to ascertain the pooled ADR in FIT-positive colonoscopy., Methods: Major databases like PubMed, EMBASE, and Web of Science were searched in October 2021 for studies reporting on ADR of colonoscopy in a FIT-positive population. Meta-analysis was performed by standard methodology using the random-effects model. Heterogeneity was assessed by I 2 and 95% prediction interval statistics., Results: Thirty-four high-quality studies that included more than 6 million asymptomatic average-risk individuals were analyzed; 2,655,345 individuals completed a screening FIT test. The pooled FIT screening rate was 69.8% (95% CI, 62.8-76.1), the pooled FIT positivity rate was 5.4% (95% CI, 4.3-6.9), and the colonoscopy completion rate was 85% (95% CI, 82.8-86.9). The pooled ADR was 47.8% (95% CI, 44.1-51.6), pooled advanced ADR was 25.3% (95% CI, 22-29), and the pooled colorectal cancer detection rate was 5.1% (95% CI, 4.4-5.9). The pooled ADR in men was 58.3% (95% CI, 52.8-63.6) and in women was 41.9% (95% CI, 36.4-47.6). The pooled ADR with qualitative FIT assessment was 67.7% (95% CI, 50.7-81), with 1-stool sample FIT was 52.8% (95% CI, 48.8-56.8), and at a cutoff threshold of 100 ng hemoglobin/mL was 52.1% (95% CI, 47-57.1). Based on time-period cumulative analysis, the ADR improved over time from 30.5% (95% CI, 24.6-37.2) to 47.8% (95% CI, 44.1-51.6)., Conclusions: This meta-analysis supports the current ADR benchmarks for colonoscopy in FIT-positive individuals. Excellent pooled ADR parameters were demonstrated with qualitative assessment of 1 stool sample at a test cutoff value of 100 ng hemoglobin/mL, and ADR per endoscopist improved over time., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Single-use duodenoscopes and duodenoscopes with detachable/disposable caps emerged in the market to mitigate the risk of ERCP-related infections. We aimed to investigate adverse events associated with these devices occurring after U.S. Food and Drug Administration (FDA) approval., Methods: We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from July 2018 to June 2021., Results: One hundred eighty-five reports comprising 201 device issues and 118 patient adverse events were identified from July 2018 through June 2021. Most device issues related to the single-use duodenoscope were due to optical problems (7 reports). Other reported device issues included difficulty in advancing the duodenoscope (2 reports), fluid leak (2 reports), and use-of-device problems (2 reports). Among the duodenoscopes with detachable/disposable caps, most device issues were related to bacterial contamination (53 reports), followed by issues with device use (31 reports), detachment/separation of the device (25 reports), and crack/dent in device material (16 reports). Overall, the most frequently reported patient adverse events were tissue injury (63 reports), perforation (8 reports), and bleeding (7 reports). Ninety reports of microbial contamination of duodenoscopes with detachable/disposable caps were identified, of which Pseudomonas aeruginosa was most common., Conclusions: Findings from the MAUDE database highlight patient and device adverse events that endoscopists should be aware of in using single-use duodenoscopes and duodenoscopes with detachable/disposable caps. Whereas these devices mitigate the risk of transmitting infection, they are associated with additional device-associated adverse events., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Use of hydrogen peroxide (H 2 O 2 ) has been reported in direct endoscopic necrosectomy (DEN) of pancreatic walled-off necrosis (WON). The aim of this meta-analysis was to study the pooled clinical outcomes of H 2 O 2 -assisted DEN of pancreatic WON., Methods: We conducted a comprehensive search of several databases (inception to July 2021) to identify studies reporting on the use of H 2 O 2 in DEN of WON. A random-effects model was used to calculate pooled rates and I 2 values, and 95% prediction intervals were used to assess heterogeneity. The outcomes studied were technical success, clinical success, and adverse events in H 2 O 2 -assisted DEN of pancreatic WON., Results: In 7 analyzed studies, 186 patients underwent H 2 O 2 -assisted DEN of WON. The pooled rate of technical success was 95.8% (95% confidence interval [CI], 88.5-98.5), clinical success was 91.6% (95% CI, 86.1-95), and cumulative rate of overall adverse events was 19.3% (95% CI, 7.6-41). The pooled rate of bleeding was 7.9% (95% CI, 2.4-22.7), stent migration was 11.3% (95% CI, 4.9-23.9), perforation 5.4% (95% CI, 1.7-15.7), infection 5.7% (95% CI, 2-15.1), and pulmonary adverse event 2.9% (95% CI, 1.3-6.1). Mean treatment sessions ranged from 2 to 5., Conclusions: H 2 O 2 -assisted DEN of WON demonstrated excellent clinical outcomes, with minimal heterogeneity. No adverse events attributable to H 2 O 2 were reported. Future controlled studies are warranted comparing the clinical outcomes with and without H 2 O 2 before H 2 O 2 use can be established in DEN of pancreatic WON., (Copyright © 2022. Published by Elsevier Inc.)

Background and Aims: Several methods with variable efficacy have been proposed for difficult biliary cannulation in ERCP. We assessed the comparative efficacy of different strategies for difficult biliary cannulation through a network meta-analysis combining direct and indirect treatment comparisons., Methods: We identified 17 randomized controlled trials (2015 patients) that compared the efficacy of different adjunctive methods for difficult biliary cannulation (needle-knife techniques, pancreatic guidewire-assisted technique, pancreatic-assisted technique, and transpancreatic sphincterotomy) either with each other or with persistence with the standard cannulation techniques. The success rate of biliary cannulation and the incidence of post-ERCP pancreatitis (PEP) were the outcomes of interest. We performed pairwise and network meta-analysis for all treatments and used Grading of Recommendations Assessment, Development and Evaluation criteria to appraise quality of evidence., Results: Low-quality evidence supported the use of transpancreatic sphincterotomy over persistence with standard cannulation techniques (risk ratio [RR], 1.29; 95% confidence interval [CI], 1.05-1.59) and over any other adjunctive intervention (RR, 1.21 [95% CI, 1.01-1.44] vs pancreatic guidewire-assisted technique, RR, 1.19 [95% CI, 1.01-1.43] vs early needle-knife techniques, RR, 1.47 [95% CI, 1.03-2.10] vs pancreatic stent-assisted technique) for increasing the success rate of biliary cannulation. No other significant results were observed in any other comparisons. Based on the network model, transpancreatic sphincterotomy (P-score, .97) followed by early needle-knife techniques (P-score, .62) were ranked highest in terms of increasing the success rate of biliary cannulation. Early needle-knife techniques outperformed persistence with standard cannulation techniques in terms of decreasing PEP rate (RR, .61; 95% CI, .37-1.00), whereas both early needle-knife techniques and transpancreatic sphincterotomy led to lower PEP rates as compared with pancreatic guidewire-assisted technique (RR, .49 [95% CI, .23-.99] and .53 [95% CI, .30-.92], respectively)., Conclusions: Transpancreatic sphincterotomy increases the success rate of biliary cannulation as compared with persistence with the standard cannulation techniques. Early needle-knife techniques and transpancreatic sphincterotomy are superior to other interventions in decreasing PEP rates and should be considered in patients with difficult cannulation., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Gastric antral vascular ectasia (GAVE) is typically treated by endoscopic thermal therapies. Endoscopic band ligation (EBL) has been reported in the treatment of GAVE with encouraging results. However, EBL is not widely used to this end., Methods: We conducted a comprehensive search of several databases (inception to May 2021) to identify studies reporting on the use of EBL in the treatment of GAVE. A random-effects model was used to calculate the pooled rates; I 2 values and 95% prediction intervals were calculated to assess the heterogeneity., Results: Ten studies (194 patients) were included in the final analysis. The pooled rate of treatment responders with EBL in GAVE was 81% (95% confidence interval [CI], 62.2-91.7), and GAVE recurrence was 15.4% (95% CI, 4.5-41.3). The pooled mean number of treatment sessions required was 2.4 (95% CI, 2.2-2.7), and the number of bands used to achieve eradication per patient was 15.1 (95% CI, 10.7-19.4). The pooled mean difference of pre- to post-treatment hemoglobin was 1.5 (95% CI, .9-2.2; P = .001), pre- to post-treatment units of packed red blood cells transfused was 1.1 (95% CI, .4-1.9; P = .002), and pre- to post-treatment hospital length of stay was .5 days (95% CI, .1-.9; P = .01). The pooled rate of overall adverse events was 15.9% (95% CI, 10.4-23.7)., Conclusions: EBL demonstrated excellent clinical outcomes in the treatment of GAVE with minimal adverse events. Multicenter randomized controlled trials comparing EBL and other modalities as initial therapy are warranted., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The safety of endoscopist-directed nurse-administered propofol sedation (EDNAPS) has been demonstrated in low-risk patients (American Society of Anesthesiologists [ASA] class I and II). There are limited data regarding the safety of EDNAPS for endoscopic procedures in ASA class III patients. The purpose of this study was to determine the safety of EDNAPS for routine outpatient endoscopy in this population., Methods: We retrospectively reviewed all outpatient EGDs and colonoscopies performed with EDNAPS at the University of Utah from January 2015 to November 2018. Exclusion criteria were inpatient procedures, combined procedures, ASA IV or higher, use of continuous or bilevel positive airway pressure at the start of the procedure, or procedures performed by a nongastroenterologist. Major adverse events were defined as intubation or death. Minor adverse events were defined as hypoxia, hypotension, bradycardia, or need for airway interventions. Patients were stratified by procedure type and ASA I/II status and were compared with patients with ASA III status and matched according to age, gender, and the involvement of a fellow in a 3 to 1 fashion., Results: The final sample size was 18,910 colonoscopy procedures (17,205 patients) and 9178 EGD procedures (6827 patients). In both colonoscopy and EGD procedures, there were no major adverse events such as intubation, need for resuscitation, or death. The rates of any airway intervention, jaw thrust, oral nasal airway, or use of positive pressure ventilation were low in both procedure types and not different between ASA I/II and ASA III patients., Conclusion: EDNAPS is safe in both ASA I/II and ASA class III patients undergoing routine outpatient endoscopy., (Published by Elsevier Inc.)

Background and Aims: Diagnosis of GI ulcers and/or hemorrhage by wireless capsule endoscopy (WCE) is limited by the physician-dependent, tedious, time-consuming process of image and/ or video classification. Computer-aided diagnosis (CAD) by convolutional neural network (CNN)-based machine learning may help reduce this burden. Our aim was to conduct a meta-analysis and appraise the reported data., Methods: Multiple databases were searched (from inception to November 2019), and studies that reported on the performance of CNN in the diagnosis of GI ulcerations and/or hemorrhage on WCE were selected. A random-effects model was used to calculate the pooled rates. In cases where multiple 2 × 2 contingency tables were provided for different thresholds, we assumed the data tables were independent from each other. Heterogeneity was assessed by I 2 % and 95% prediction intervals., Results: Nine studies were included in our final analysis that evaluated the performance of CNN-based CAD of GI ulcers and/or hemorrhage by WCE. The pooled accuracy was 95.4% (95% confidence interval [CI], 94.3-96.3), sensitivity was 95.5% (95% CI, 94-96.5), specificity was 95.8% (95% CI, 94.7-96.6), positive predictive value was 95.8% (95% CI, 90.5-98.2), and negative predictive value was 96.8% (95% CI, 94.9-98.1). I 2 % heterogeneity was negligible except for the pooled positive predictive value., Conclusions: Based on our meta-analysis, CNN-based CAD of GI ulcerations and/or hemorrhage on WCE achieves a high-level performance. The quality of the evidence is robust, and therefore CNN-based CAD has the potential to become the first choice of machine learning to optimize WCE image/video reading., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Colonoscopy is the preferred modality for colorectal cancer screening because it has both diagnostic and therapeutic capabilities. Current consensus states that colonoscopy should be performed with initial rapid passage of the instrument to the cecum, followed by thorough evaluation for and removal of all polyps during a deliberate slow withdrawal. Reports have suggested that polyps that are seen but not removed during insertion are sometimes quite difficult to find during withdrawal., Methods: We performed a comprehensive literature search of several major databases (from inception to March 2020) to identify randomized controlled trials comparing inspection and polypectomy during the insertion phase as opposed to the traditional practice of inspection and polypectomy performed entirely during the withdrawal phase. We examined differences in terms of adenoma detection rate (ADR), polyps detected per patient (PDPP), cecal intubation time (CIT), withdrawal time, and total procedure time., Results: Seven randomized controlled trials, including 3834 patients, were included in our final analysis. The insertion/withdrawal cohort had 1951 patients and the withdrawal-only cohort 1883 patients. Pooled odds of adenoma detection in the insertion/withdrawal cohort was .99 (P = .8). ADR was 47.2% in the insertion/withdrawal cohort and 48.6% in the withdrawal-only cohort. Although total procedure and withdrawal times were shorter in the insertion/withdrawal cohort, PDPP in both cohorts were not statistically significant (1.4 vs 1.5, P = .7)., Conclusions: Additional inspection and polypectomy during the insertion and withdrawal phases of colonoscopy offer no additional benefit in terms of ADR or PDPP., (Copyright © 2021. Published by Elsevier Inc.)

Background and Aims: Self-expandable metal stents (SEMSs) are used for palliation of malignant gastric outlet obstruction (GOO). Studies comparing covered SEMSs (C-SEMSs) and uncovered SEMSs (U-SEMSs) have led to inconclusive results. We compared efficacy and safety of C-SEMSs versus U-SEMSs in patients with GOO., Methods: We searched MEDLINE, EMBASE, and Cochrane Library from 2000 to 2019 to identify available studies comparing C-SEMSs versus U-SEMSs in patients with GOO. Primary outcomes were stent survival and patient survival, whereas secondary outcomes were clinical and technical success, Gastric Outlet Obstruction Score System (GOOSS) score after the procedure, overall adverse events, reintervention rate, dysfunction rate, stent occlusion, and stent migration., Results: Overall, 7 randomized controlled trials and 9 observational studies were identified that included 1741 patients. C-SEMSs were associated with higher stent survival (hazard ratio, .68; 95% confidence interval [CI], .48-.96), whereas patient survival did not statistically significantly differ between C-SEMS and U-SEMS groups (hazard ratio, .96; 95% CI, .75-1.23). Clinical and technical success were not statistically different between groups (odds ratios, 1.1 [95% CI, .76-1.61] and .69 [95% CI, .21-2.3], respectively). There were no differences in terms of overall adverse events, reintervention rate, dysfunction rate, and GOOSS rate ≥2 after SEMS placement. U-SEMSs were associated with a higher rate of occlusion (odds ratio, .34; 95% CI, .21-.53) and C-SEMSs with a higher rate of migration (odds ratio, 4.28; 95% CI, 2.79-6.57)., Conclusions: C-SEMSs were associated with higher stent survival (time between stent deployment and stent dysfunction) compared with U-SEMSs, whereas no differences in terms of patient survival (time between stent deployment and patient's death) emerged. However, U-SEMSs were associated with higher risk of occlusion and C-SEMSs with higher risk of migration. Further studies using new C-SEMSs with an antimigration system are needed., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: High rates of technical and clinical success were reported for lumen-apposing metal stent (LAMS) placement for peripancreatic fluid collection (PFC) drainage. However, data on the adverse event (AE) rates are heterogeneous. The aim of this study was to evaluate the incidence, severity, management, and risk factors of AEs related to the use of LAMSs for drainage of PFCs in a large cohort of patients., Methods: This is a multicenter, international, retrospective review from 15 centers of all patients who underwent placement of LAMSs for the management of PFCs. A nested case-control study was conducted in patients with (case) or without (control) AEs., Results: Three hundred thirty-three procedures in 328 patients were performed (5 patients treated with 2 LAMSs). Technical success was achieved in 321 patients (97.9%). Three hundred four patients were finally included in the study (7 excluded for lost to follow-up information; 10 excluded for deaths unrelated to LAMSs). The rate of clinical success was 89.5%. Seventy-nine LAMS-related AEs occurred in 74 of 304 patients (24.3%), after a mean time of 25.3 days (median, 18 days; interquartile range, 6-30) classified as 20 (25.3%) mild, 54 (68.4%) moderate, or 5 (6.3%) severe. On multivariable analysis compared with control subjects, cases were more likely to have walled-off necrosis (WON) versus pancreatic pseudocysts (odds ratio, 2.18; 95% confidence interval, 1.09-4.46; P = .028), whereas cases were less likely to have undergone tract (balloon) dilation (yes vs no; odds ratio, .47; 95% confidence interval, .22-.93; P = .034)., Conclusions: Data from this large international retrospective study confirm that the use of LAMSs for management of PFCs has excellent technical and good clinical success rates. The rate of AEs, however, is not negligible and should be carefully considered before using these stents for drainage of PFCs and in particular for WON. Further prospective studies are needed to confirm these findings. (Clinical trial registration number: NCT03544008.)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. All rights reserved.)

Background and Aims: Risk of progression in Barrett's esophagus (BE) with low-grade dysplasia (LGD) and high-grade dysplasia (HGD) has been established. However, the natural history of BE with indefinite dysplasia (BE-IND) remains unclear. We performed a systematic review and meta-analysis to estimate the pooled risk of progression to HGD and/or esophageal adenocarcinoma (EAC) in BE-IND., Methods: We performed a systematic search of multiple databases to June 2018 to identify studies reporting the incidence of HGD, EAC, or HGD/EAC as an outcome in patients with BE-IND undergoing endoscopic surveillance. The pooled incidence rate of HGD and/or EAC and EAC alone was estimated., Results: We identified 8 studies reporting the incidence of HGD and/or EAC and 5 studies reporting the incidence of EAC in BE-IND. The pooled incidence of HGD and/or EAC (89 cases in 1441 patients over 5306.2 person-years) was 1.5 per 100 person-years (95% confidence interval [CI], 1.0-2.0). The pooled incidence of EAC (40 cases in 1266 patients over 4520.2 person-years) was 0.6 per 100 person-years (95% CI, 0.1-1.1). Substantial heterogeneity was noted in the analyses. On subgroup analysis, the incidence of EAC was higher in studies from Europe compared with North America (0.9% vs 0.1%, P = .01). The pooled incidence of LGD was 11.4 per 100 person-years (95% CI, 0.06-0.2)., Conclusion: The estimated incidence of HGD and/or EAC and EAC alone in BE-IND is similar to the previously reported progression risk in BE-LGD. Based on these risk estimates, patients with BE-IND should be placed on active endoscopic surveillance., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent., Methods: A phase III, multicenter, prospective, noninferiority, randomized controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Postdeployment dysphagia score at 2 weeks and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks., Results: Sixty patients were randomized (SEMS-NV: 30 patients, mean age 67 ± 13 years; SEMS-V: 30 patients, mean age 65 ± 12 years). Baseline dysphagia scores (SEMS-NV, 2.5 ± .8; SEMS-V, 2.5 ± .8) and GERD-HRQL scores (SEMS-NV, 11.1 ± 8.2; SEMS-V, 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. A similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia (SEMS-NV, 71%; SEMS-V, 74%; 95% confidence interval, 1.93 [-17.8 to 21.7]). The dysphagia scores were also similar across all follow-up time points. Mean GERD-HRQL scores improved by 7.4 ± 10.2 points in the SEMS-V arm and by 5.2 ± 8.3 in the SEMS-NV group (P = .96). The GERD-HRQL scores were similar across all follow-up time points. Aspiration pneumonia occurred in 3.3% in the SEMS-NV arm and 6.9% in the SEMS-V arm (P = .61). Migration rates were similar (SEMS-NV, 33%; SEMS-V, 48%; P = .29). Two SEMS-V spontaneously fractured. There was no perforation, food impaction, or stent-related death in either group., Conclusions: The SEMS-V was equally effective in relieving dysphagia as compared with the SEMS-NV. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents, implying either that the valve was not effective or that all patients on proton pump inhibitors could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended. (Clinical trial registration number: NCT02159898.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)