Adverse events with endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction-A systematic review and meta-analysis.

BACKGROUND: The technical and clinical effectiveness of endoscopic ultrasonography (EUS)-guided gastroenterostomy (GE) has been reported by several meta-analyses, but few of them have addressed the adverse events (AE). The goal of the current meta-analysis was to analyze the AEs associated with various types of EUS-GE. METHODS: All relevant studies reporting the AEs with EUS-GE were searched from 2000 to 31st March 2023 in MEDLINE, Embase, and Scopus. The event rates were pooled using a random effects model. RESULTS: A total of 36 studies (n = 1846) were included in the meta-analysis. The present meta-analysis reports a pooled technical success rate of 96.9% (95.9-98.0; I2 = 29.3%) with a pooled clinical success rate of 90.6% (88.5-92.7; I2 = 60.9%). The pooled incidence of overall AEs with EUS-GE was 13.0% (10.3-15.7; I2 = 69.7%), with the commonest being maldeployment of the stent, seen in 4.6% (3.2-6.0; I2 = 50.6%). The pooled incidences of serious AE and procedure-related mortality were 1.2% (0.7-1.8; I2 = 1.9%) and 0.3% (0.0-0.7; I2 = 0.0%), respectively. Subgroup analysis of studies using only the free-hand technique showed a significantly lower overall AE and maldeployment but not serious AE and other individual AEs. The pooled incidences of delayed stent migration and stent occlusion were 0.5% (0.0-1.1; I2 = 0.0%) and 0.8% (0.2-1.3; I2 = 0.0%), respectively. CONCLUSION: Despite a technical and clinical success rate of >90%, AEs are seen in around one-seventh of the cases of EUS-GE, maldeployment being the commonest. However, the pooled incidence of serious AE and mortality remains low, which is reassuring.

Safety of Endoscopic Procedures in Thrombocytopenia and Neutropenia: Embracing Assurance.

BACKGROUND: Few studies have evaluated the post-endoscopic adverse events in patients with neutropenia and thrombocytopenia. Current guidelines do not provide clear direction on this topic. AIM: We explore the pooled rates of safety and adverse effects of endoscopic interventions in thrombocytopenia and neutropenia patients via a systematic review & meta-analysis. METHODS: Databases, including Medline, Scopus, and Embase, were searched (in May 2023) using specific terms for studies evaluating the clinical outcomes of endoscopy in patients with thrombocytopenia and neutropenia. Standard meta-analysis methods were employed using the random-effects model. I2% heterogeneity was used to assess the heterogeneity. RESULTS: Six studies and four studies evaluated endoscopic outcomes in patients with thrombocytopenia and neutropenia respectively with mean age was 56 years. The pooled rate of total post-biopsy bleeding and total post-polypectomy bleeding among patients with thrombocytopenia was 4% (95% CI 1-11), I2 = 84%, and 12% (95% CI 3-36) I2 = 43%. The total rate of post procedure-related bleeding in thrombocytopenia was 5% (95% CI 1-14) I2 = 95%. The pooled rate of post-endoscopic infection (fever from any cause, bacteremia) in neutropenia was 10% (95% CI 3-28%) I2 = 96%. On sub analysis, the pooled rate of bacteremia and 30 days all-cause mortality in neutropenia was 4% (95% CI 3-5%) I2 = 0% and 13% (95% CI 4-34%) I2 = 95% respectively. CONCLUSION: Our data supports the notion that endoscopic procedures are safe for neutropenic, thrombocytopenic patients with suitable indications and reasonable functional status and have an acceptable risk/benefit ratio.

Predicting the risk of early intensive care unit admission for patients hospitalized with acute pancreatitis using supervised machine learning.

Background: Acute pancreatitis (AP) is a complex and life-threatening disease. Early recognition of factors predicting morbidity and mortality is crucial. We aimed to develop and validate a pragmatic model to predict the individualized risk of early intensive care unit (ICU) admission for patients with AP. Methods: The 2019 Nationwide Readmission Database was used to identify patients hospitalized with a primary diagnosis of AP without ICU admission. A matched comparison cohort of AP patients with ICU admission within 7 days of hospitalization was identified from the National Inpatient Sample after 1:N propensity score matching. The least absolute shrinkage and selection operator (LASSO) regression was used to select predictors and develop an ICU acute pancreatitis risk (IAPR) score validated by 10-fold cross-validation. Results: A total of 1513 patients hospitalized for AP were included. The median age was 50.0 years (interquartile range: 39.0-63.0). The three predictors that were selected included hypoxia (area under the curve [AUC] 0.78), acute kidney injury (AUC 0.72), and cardiac arrhythmia (AUC 0.61). These variables were used to develop a nomogram that displayed excellent discrimination (AUC 0.874) (bootstrap bias-corrected 95% confidence interval 0.824-0.876). There was no evidence of miscalibration (test statistic = 2.88; P = 0.09). For high-risk patients (total score >6 points), the sensitivity was 68.94% and the specificity was 92.66%. Conclusions: This supervised machine learning-based model can help recognize high-risk AP hospitalizations. Clinicians may use the IAPR score to identify patients with AP at high risk of ICU admission within the first week of hospitalization.

Safety and efficacy of thalidomide in treatment of gastrointestinal bleeding secondary to angioectasias: a systematic review and meta-analysis.

BACKGROUND: Thalidomide has been used for angioectasia-associated refractory gastrointestinal bleeding (GIB), with studies showing variable efficacy and side effects profile. We conducted a meta-analysis to reconcile the data. METHODS: Online databases were searched for studies evaluating thalidomide in patients with refractory/recurrent GIB due to angioectasias. The outcomes of interest were cessation of bleeding, rebleeding, need for blood transfusion, hospitalization and adverse events. Pooled proportions for incidence, and odds ratios (OR) for comparison with control were calculated along with 95% confidence interval (CI). RESULTS: A total of seven studies with 346 patients (n = 269 thalidomide, n = 77 control) were included. Thalidomide dose was usually started at 50-100mg/day. The mean age was 65 years, 45% patients were men, and mean follow-up was 1.8 years. The pooled clinical outcomes with thalidomide were: cessation of bleeding 42.2% (95% CI 36.02 to 48.41), rebleeding 30%, need for blood transfusion 20.1%, hospitalization 40% and adverse events 55.9%. When compared with the control group in 2 studies, patients on thalidomide had significantly higher odds of cessation of bleeding (OR 21.40, 95% CI 5.78 to 79.29, p < 0.00001) and adverse events, with lower need for blood transfusion and hospitalization. DISCUSSION: In patients with angioectasias-related refractory/recurrent GIB, the use of thalidomide results in significantly decreased bleeding risk and may play a role in the management of such patients.

Meta-Analysis of Endoscopic Full-Thickness Resection Versus Endoscopic Submucosal Dissection for Complex Colorectal Lesions.

BACKGROUND: Studies evaluating endoscopic full-thickness resection (EFTR) and endoscopic submucosal dissection (ESD) for complex colorectal lesions have shown variable results. We conducted a meta-analysis of the available data. METHODS: Online databases were searched for studies comparing EFTR versus ESD for complex colorectal lesions. The outcomes of interest were resection rates, procedure time (min), and complications. Pooled odds ratios (OR) and standardized mean difference (SMD) along with 95% CI were calculated. RESULTS: A total of 4 studies with 530 patients (n=215 EFTR, n=315 ESD) were included. The mean follow-up duration was 5 months. The mean age of the patients was 68 years and 64% were men. The EFTR and ESD groups had similar rates of en bloc resection (OR: 1.73, 95% CI: 0.60-4.97, P=0.31) and R0 resection (OR: 1.52, 95% CI: 0.55-4.14, P=0.42). The EFTR group had significantly reduced procedure time (SMD -1.87, 95% CI: -3.13 to -0.61, P=0.004), total complications (OR: 0.24, 95% CI: 0.13-0.44, P<0.00001), perforation (OR: 0.12, 95% CI: 0.03-0.39, P=0.0005) and postresection electrocoagulation syndrome (OR: 0.06, 95% CI: 0.01-0.48, P=0.008). Delayed bleeding was similar in the 2 groups (OR: 0.80, 95% CI: 0.30-2.12, P=0.66). Residual/recurrent lesions were significantly higher in the EFTR group (OR: 4.67, 95% CI: 1.39-15.66, P=0.01). DISCUSSION: This meta-analysis of small studies with high heterogeneity showed that EFTR and ESD have comparable resection rates for complex colorectal lesions. EFTR is faster and has fewer complications, but it increases residual or recurrent lesions.

Efficacy of Endoscopic Therapy in Symptomatic Pancreatic Divisum: A Systematic Review and Meta-analysis.

BACKGROUND AND AIMS: Pancreas divisum (PD) is a congenital malformation of the pancreas and is implicated as a cause of pancreatitis. The role of endotherapy has been variable in symptomatic PD indicated by recurrent acute pancreatitis (RAP), chronic pancreatitis (CP), or chronic pancreatic-type abdominal pain (PP). The aim of this study was to analyze the pooled data to determine the success of endoscopic intervention for pancreas divisum. METHODS: We conducted a comprehensive search of several databases (inception to July 2023) to identify studies reporting on the use of endoscopic therapy in symptomatic pancreatic divisum. The random-effects model was used to calculate the pooled rates and I2% values were used to assess the heterogeneity. RESULTS: A total of 27 studies were retrieved that reported endoscopic intervention in pancreatic divisum. The calculated pooled rate of technical success was 92% (95% CI: 87-95; I2=63%). The calculated pooled rate of clinical success was 65% (95% CI: 60-70; I2=60%). The rate of clinical success by PD subtypes was highest in RAP at 71% (95% CI: 65-76; I2=24%). Available studies had significant heterogeneity in defining clinical success. The rate of adverse events was 71% (95% CI: 65-76; I2=24%). CONCLUSIONS: The role of endoscopic therapy in pancreatic divisum is variable with the highest success rate in recurrent acute pancreatitis. Endoscopic intervention is associated with a higher-than-usual rate of adverse events, including post-ERCP pancreatitis.

Prevalence of endoscopy-related injuries and their impact on clinical practice: a systematic review and meta-analysis.

BACKGROUND: Endoscopy-related musculoskeletal injuries (ERIs) are commonly reported but their exact prevalence and clinical impact remain obscure. We conducted a systematic review and meta-analysis of the current literature aiming to answer these questions. METHODS: The MEDLINE, EMBASE, and SCOPUS databases were searched for studies evaluating ERIs in gastroenterologists and surgeons. The co-primary outcome was the prevalence of ERIs (i.e. carpal tunnel syndrome, de Quervain's tenosynovitis, and hand numbness). The second co-primary outcome was the prevalence of endoscopy-related pain syndromes. RESULTS: 12 studies, including 4563 respondents, were included. The majority of respondents were men (n = 3321; 72.8%) and most were right-handed (86.2%). The career prevalence of carpal tunnel syndrome (pooled from 10 studies) was 5.3% (95%CI 1.5%-8.9%; I 2 = 97.1%), while the prevalence of de Quervain's tenosynovitis (five studies) was 8.5% (95%CI 0.1%-17.0%). The pooled prevalences of thumb pain, neck pain, and back pain were 25.4%, 23.1%, and 19.7%, respectively, but the prevalence varied according to the type of questionnaire used. Only 341/864 respondents (39.5%) had received prior training in ergonomics, while 623/889 respondents (70.1%) expressed a desire for further training in ergonomics. Overall, there is a moderate risk of bias in the present literature. CONCLUSION: ERIs, including carpal tunnel syndrome, de Quervain's tenosynovitis, and endoscopy-related pain, are very common. These injuries can be severe, requiring surgery, and lead to loss of productivity. Most gastroenterologists report an unmet need for training in the proper ergonomics of endoscopy.

Efficacy and safety of endoscopic submucosal dissection for colorectal dysplasia in patients with inflammatory bowel disease: a systematic review and meta-analysis.

BACKGROUND/AIMS: In this meta-analysis, we studied the safety and efficacy of endoscopic submucosal dissection (ESD) for colorectal dysplasia in patients with inflammatory bowel disease (IBD). METHODS: Multiple databases were searched, and studies were retrieved based on pre-specified criteria until October 2022. The outcomes assessed were resection rates, procedural complications, local recurrence, metachronous tumors, and the need for surgery after ESD in IBD. Standard meta-analysis methods were followed using the random-effects model, and I2% was used to assess heterogeneity. RESULTS: Twelve studies comprising 291 dysplastic lesions in 274 patients were included with a median follow-up of 25 months. The pooled en-bloc resection, R0 resection, and curative resection rates were 92.5% (95% confidence interval [CI], 87.9%-95.4%; I2=0%), 81.5% (95% CI, 72.5%-88%; I2=43%), and 48.9% (95% CI, 32.1%-65.9%; I2=87%), respectively. The local recurrence rate was 3.9% (95% CI, 2%-7.5%; I2=0%). The pooled rates of bleeding and perforation were 7.7% (95% CI, 4.5%-13%; I2=10%) and 5.3% (95% CI, 3.1%-8.9%; I2=0%), respectively. The rates of metachronous recurrence and additional surgery following ESD were 10% (95% CI, 5.2%-18.2%; I2=55%) and 13% (95% CI, 8.5%-19.3%; I2=54%), respectively. CONCLUSIONS: ESD is safe and effective for the resection of dysplastic lesions in IBD with an excellent pooled rate of en-bloc and R0 resection.

Conventional Versus Traction Endoscopic Submucosal Dissection for Colorectal Tumors: A Meta-analysis of Randomized Controlled Trials.

INTRODUCTION: Compared with conventional endoscopic submucosal dissection (C-ESD) for colorectal lesions, the traction method (T-ESD) allows the lesion to be stabilized with easier dissection. However, randomized controlled trials (RCTs) have reported conflicting results on the clinical outcomes of T-ESD as compared with C-ESD. We conducted a meta-analysis to compile the data. METHODS: Multiple databases were searched for RCTs evaluating C-ESD versus T-ESD for colorectal tumors. The end points of interest were procedure time (min), resection speed (mm²/min), R0 resection, en bloc resection, delayed bleeding, and perforation. Standard meta-analysis methods were employed using the random-effects model. RESULTS: Six RCTs with a total of 566 patients (C-ESD n=284, T-ESD n=282) were included. The mean age was 67±10 y and 60% were men. As compared with the T-ESD technique, the C-ESD group was associated with longer procedure time (SMD 0.91, 95% CI 0.58 to 1.23, P<0.00001) and lesser resection speed (SMD -1.03, 95% CI -2.01 to -0.06, P=0.04). No significant difference was found in the 2 groups with respect to R0 resection rate (RR 1.00, 95% CI 0.94 to 1.06, P=0.87), en bloc resection (RR 0.99, 95% CI 0.97 to 1.01, P=0.35), delayed bleeding (RR 0.66, 95% CI 0.17 to 2.59, P=0.55) and perforation (RR 2.16, 95% CI 0.75 to 6.27, P=0.16). DISCUSSION: On meta-analysis, pooled procedure time was significantly faster with T-ESD compared with C-ESD. The clinical outcomes, however, were comparable.

Renal replacement therapy prior to liver transplant and inpatient mortality in patients without advanced kidney disease: A nationwide study.

Background and Aim: The utility of renal replacement therapy (RRT) before liver transplant (LT) in patients without end-stage renal disease (ESRD) or advanced chronic kidney disease (CKD-IV/V) is debatable and lacks data support. We aimed to evaluate the impact of RRT on patients undergoing LT. Methods: We used the National Readmission Database (2016-2019) to identify all index hospitalizations undergoing RRT before LT (cases). A matched comparison cohort of similar hospitalizations without RRT before LT was identified (controls) after 1:1 propensity score matching for age, gender, and available comorbidities. Results: We matched 364 cases (RRT before LT) to 364 controls (LT without prior RRT). There was no statistical difference in all-cause inpatient mortality (4.9% vs 3.6% P = 0.4). A significantly greater proportion of cases were associated with ICU admission (40.7% vs 17.0%, P < 0.001) and RRT requirement post LT (100% vs 17%, P < 0.001). There was no difference in 30- (hazard ratio [HR] 1.1, 0.4-2.6), 60- (HR 0.9, 0.4-1.8), or 90-day (HR 0.8, 0.4-1.6) inpatient mortality between the groups. Also, 180-day survival estimates were comparable (P = 0.5). The results were similar in patients with no chronic kidney disease (CKD) and CKD-III. Conclusion: RRT prior to LT, in patients without advanced CKD or ESRD, was associated with greater instances of ICU stay and need for future RRT. Also, 30-, 60-, and 90-day inpatient mortality rates were similar, and 180-day survival estimates were comparable.

Diagnostic accuracy of bowel ultrasonography in patients with inflammatory bowel disease: a systematic review and meta-analysis.

Background: Bowel ultrasonography (BUS) is emerging as a promising noninvasive tool for assessing disease activity in inflammatory bowel disease (IBD) patients. We evaluated the diagnostic accuracy of BUS in IBD patients against the gold standard diagnostic method, standard colonoscopy. Methods: Major databases were searched from inception to May 2023 for studies on BUS diagnostic accuracy in IBD. Outcomes of interest were pooled sensitivity, specificity, positive (PPV), and negative (NPV) predictive values. Endoscopic confirmation served as ground truth. Standard meta-analysis methods with a random-effects model and I2 statistics were applied. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Results: Twenty studies (1094 patients) were included in the final analysis. The majority (75%) of studies considered bowel wall thickness >3 mm as abnormal. Endoscopic evaluation was performed between days 3 and 180. The pooled diagnostic accuracy of BUS in IBD was 66% (95% confidence interval [CI] 58-72%; I2=78%), sensitivity was 88.6% (95%CI 85-91%; I2=77%), and specificity 86% (95%CI 81-90%; I2=95%). PPV and NPV were 94% (95%CI 93-96%; I2=25%) and 74% (95%CI 66-80%; I2=95%), respectively. On subgroup analysis, small-intestine contrast-enhanced ultrasonography (SICUS) demonstrated high sensitivity (97%, 95%CI 91-99%; I2=83%), whereas BUS exhibited high specificity (94%, 95%CI 92-96%; I2=0%) and NPV (76%, 95%CI 68-83%; I2=80.9%). Meta-regression revealed a significant relation between side-to-side anastomosis and BUS specificity (P=0.02) and NPV (P=0.004). Conclusion: The high diagnostic accuracy of BUS in detecting bowel wall inflammation suggests utilizing regular BUS as the primary modality, with subsequent consideration of SICUS if clinically warranted.

Cold Snare Polypectomy in Small (<10 mm) Pedunculated Colorectal Polyps: A Systematic Review and Meta-analysis.

INTRODUCTION: Endoscopic removal techniques for colorectal polyps include cold snare polypectomy (CSP) and hot snare polypectomy (HSP). Although HSP is recommended for pedunculated polyps (PPs) larger than 10 mm, data regarding use of CSP for PPs <10 mm continues to emerge. We aimed to investigate outcomes of these techniques in small (<10 mm) pedunculated colorectal polyps. METHODS: Multiple databases were searched till June 2022 to identify studies involving the removal of small PPs with CSP and HSP. Random effects model was used to calculate outcomes and 95% CI. Primary outcome was the pooled rate of successful en-bloc resection. Secondary outcomes were immediate and delayed bleeding with CSP and HSP as well as prophylactic and post resection clip placement. RESULTS: Six studies including 1025 patients (1111 polyps with a mean size 4 to 8.5 mm) were analyzed. 116 and 995 polyps were removed with HSP and CSP, respectively. The overall pooled rate of successful en-bloc resection with CSP was 99.7% (CI 99.1-99.9; I2 0%). Pooled immediate and delayed bleeding after CSP was 49.8% (CI 46.8-52.91; I2 98%) and 0% (CI 0.00-0.00; I2 0%), respectively. Delayed bleeding was higher with HSP, relative risk 0.05 (CI 0.01-0.43; I2 0%), P =0.006, whereas immediate bleeding was higher with CSP, relative risk 7.89 (CI 4.36-14.29; I2 0%), P <0.00001. Pooled rates of prophylactic clip placement and post-procedure clip placement (to control immediate bleeding) were 55.3% and 47.2%, respectively. Finally, right colon polyp location significantly correlated with frequency of immediate bleeding. CONCLUSION: Our analysis shows that CSP is safe and effective for resection of small PPs.

Safety and Effectiveness of Vedolizumab in Elderly Patients with Inflammatory Bowel Disease: A Systematic Review & Meta-Analysis.

BACKGROUND: There is limited data on Vedolizumab utilization in elderly patients. Our study aims to assess the effectiveness and safety of Vedolizumab in this subset population. MATERIALS AND METHODS: Databases including Cochrane Central, Embase, Medline (via Ovid), Scopus, and Web of Science were searched in August 2022 to identify studies that assessed Vedolizumab therapy in elderly patients. Pooled proportion and risk ratios (RR) were calculated. RESULTS: Total 11 studies with 3546 IBD patients (1314 elderly and 2232 young) were included in the final analysis. Pooled rate of overall and serious infections in the elderly cohort was 8.45% (95% CI=6.27-11.29; I 2 23%) and 2.59% (95% CI=0.78-8.29; I 2 76%), respectively. However, there was no difference in overall infection rates between elderly and young patients. Pooled rate of endoscopic, clinical, and steroid-free remission for elderly IBD patients was 38.45% (95% CI=20.74-59.56; I 2 93%), 37.95% (95% CI=33.08-43.06; I 2 13%), and 38.8% (95% CI=31.6-46.4; I 2 77%), respectively. Elderly patients had lower steroid-free remission rates [RR 0.85, 95% CI=0.74-0.99; I 2 0%, P =0.03]; however, there was no difference in rates of clinical (RR 0.86, 95% CI=0.72-1.03; I 2 0%, P =0.10) or endoscopic remission (RR 1.06, 95% CI=0.83-1.35; I 2 0%, P =0.63) compared with younger patients. Pooled rate of IBD-related surgery and IBD-related hospitalizations was 9.76% (95% CI=5.81-15.92; I 2 78%) and 10.54% (95% CI=8.37-13.2; I 2 0%), respectively for the elderly cohort. There was no statistical difference in IBD-related surgeries between elderly and young IBD patients, RR 1.20 (95% CI=0.79-1.84; I 2 16%), P =0.4. CONCLUSIONS: Vedolizumab is equally safe and effective for clinical and endoscopic remission in elderly and younger populations.

Device-assisted endoscopic full-thickness resection in colorectum: Systematic review and meta-analysis.

OBJECTIVES: Endoscopic full-thickness resection (EFTR) is emerging as an effective modality for mucosal and submucosal lesions in the colorectum. In this systematic review and meta-analysis, we aimed to analyze the success and safety of device-assisted EFTR in the colon and rectum. METHODS: A literature search was performed in the Embase, PubMed, and Medline databases for studies evaluating device-assisted EFTR between inception to October 2022. The primary outcome of the study was clinical success (R0 resection) with EFTR. Secondary outcomes included technical success, procedure duration, and adverse events. RESULTS: In all, 29 studies with 3467 patients (59% male patients, 3492 lesions) were included in the analysis. The lesions were located in right colon (47.5%), left colon (28.6%), and rectum (24.3%). EFTR was performed for subepithelial lesions in 7.2% patients. The pooled mean size of the lesions was 16.6 mm (95% confidence interval [CI] 14.9-18.2, I2 98%). Technical success was achieved in 87.1% (95% CI 85.1-88.9%, I2 39%) procedures. The pooled rate of en bloc resection was 88.1% (95% CI 86-90%, I2 47%) and R0 resection was 81.8% (95% CI 79-84.3%, I2 56%). In subepithelial lesions, the pooled rate of R0 resection was 94.3% (95% CI 89.7-96.9%, I2 0%). The pooled rate of adverse events was 11.9% (95% CI 10.2-13.9%, I2 43%) and major adverse events requiring surgery was 2.5% (95% CI 2.0-3.1%, I2 0%). CONCLUSION: Device-assisted EFTR is a safe and effective treatment modality in cases with adenomatous and subepithelial colorectal lesions. Comparative studies are required with conventional resection techniques, including endoscopic mucosal resection and submucosal dissection.

Cold Versus Hot Endoscopic Mucosal Resection for Sessile Serrated Colorectal Polyps ≥10 mm: A Systematic Review and Meta-analysis.

INTRODUCTION: We performed a systematic review and meta-analysis studying the efficacy and safety of cold versus hot endoscopic mucosal resection (EMR) for resection of sessile serrated polyps (SSPs) ≥10 mm. METHODS: Multiple databases were searched until January 2023 for studies reporting outcomes of cold versus hot EMR for SSPs ≥10 mm. The primary outcome was the residual SSP rate. Secondary outcomes included technical success rate, R0 resection rate, and adverse events. We used standard meta-analysis methods using the random-effects model, and I2% was used to assess heterogeneity. RESULTS: Thirteen studies were included in the final analysis. In all, 1896 SSPs were included with a mean polyp size of 23.7 mm (range, 15.9 to 33). A total of 1452 SSPs were followed up for a median follow-up duration of 15.3 months (range, 6 to 37). The pooled residual SSP rate for cold EMR was 4.5% (95% CI: 1.0-17.4), and 5.1% (95% CI: 2.4-10.4) for hot EMR (P=0.9). The pooled rates of technical success, R0 resection, immediate bleeding, and perforation were comparable. Hot EMR was significantly associated with lower piecemeal resection (59.2% vs. 99.3%, P<0.001), higher en-bloc resection (41.4% vs. 1.4%, P<0.001), and delayed bleeding rate (4% vs. 0.7%, P=0.05) compared to cold EMR. CONCLUSIONS: Cold EMR has similar efficacy compared to hot EMR for resection of SSP ≥ 10 mm, despite limitations in piecemeal R0 resection rate reporting. Although hot EMR was associated with a higher rate of en-bloc resection, it also showed an increased risk of delayed bleeding compared to cold EMR.

Device malfunctions with use of EUS-guided fine-needle biopsy devices: Analysis of the MAUDE database.

Background: The safety of endoscopic ultrasound-guided tissue acquisition through fine-needle biopsy devices is well-established in clinical trials. The real-world experience of using these devices is not known. The authors analyzed the postmarketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to answer this question. Methods: The Food and Drug Administration MAUDE database from January 2012 to June 2022 was accessed to evaluate for device malfunctions and patient-related adverse consequences of these malfunctions. Results: There were 344 device-related issues. Most issues were due to detachment or breakage of the device (n = 185 [53.7%]). Seventy-six of the breakages (40.8%) occurred during the procedure, whereas 89 cases (47.8%) occurred while removing the needle from the endoscope. The most common site of tissue biopsy at the time of needle breakage was the pancreas (44 [23.8%]).The common patient-related adverse events were retained foreign body (n = 50 [14.5%]) followed by bleeding (16, 4.6%). Six patients (3.4%) required a second intervention for removal of the retained foreign bodies including surgery in 2 cases. The device breakage damaged the endoscope in 3 cases (1.7%), and there was 1 case of needlestick injury to the nurse. Conclusion: The fine-needle biopsy devices can be associated with needle breakage and bending; these adverse events were not previously reported. Needle breakages can result in a retained foreign body that may require additional procedures including surgery. These real-world findings from the MAUDE database may inform clinical decisions and help improve clinical outcomes.