Adverse events of the single-operator cholangioscopy system: a Manufacturer and User Facility Device Experience database analysis.

BACKGROUND AND AIMS: The SpyGlass (Boston Scientific, Marlborough, Mass, USA) single-operator cholangioscopy (SOC) system is generally considered to be safe but adds additional risks to those associated with standard ERCP. METHODS: We evaluated adverse events (AEs) associated with the SpyGlass system reported in the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database between January 2016 and August 2023. RESULTS: From the database, 2311 device problems (SpyGlass DS, 1301; SpyGlass DS II, 1010) were reported. An optical problem was the most reported issue (SpyGlass DS, 83; SpyGlass DS II, 457). Patient-related events were found in 62 of 1743 reports (3.5%): 33 with the SpyGlass DS and 29 with the SpyGlass DS II. The most common AEs were bleeding/hemorrhage followed by perforation; infection, fever, or sepsis; and pancreatitis. CONCLUSIONS: Our findings add to the existing literature and provide a fuller picture of potential problems associated with the SpyGlass SOC.

Comparative diagnostic yield of different endoscopic techniques for tissue sampling of upper gastrointestinal subepithelial lesions: a network meta-analysis.

BACKGROUND: There is limited evidence on the comparative diagnostic performance of endoscopic tissue sampling techniques for subepithelial lesions. We performed a systematic review with network meta-analysis to compare these techniques. METHODS: A systematic literature review was conducted for randomized controlled trials (RCTs) comparing the sample adequacy and diagnostic accuracy of bite-on-bite biopsy, mucosal incision-assisted biopsy (MIAB), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), and EUS-guided fine-needle biopsy (FNB). Results were expressed as relative risk (RR) and 95%CI. RESULTS: Eight RCTs were identified. EUS-FNB was significantly superior to EUS-FNA in terms of sample adequacy (RR 1.20 [95%CI 1.05-1.45]), whereas none of the other techniques significantly outperformed EUS-FNA. Additionally, bite-on-bite biopsy was significantly inferior to EUS-FNB (RR 0.55 [95%CI 0.33-0.98]). Overall, EUS-FNB appeared to be the best technique (surface under cumulative ranking [SUCRA] score 0.90) followed by MIAB (SUCRA 0.83), whereas bite-on-bite biopsy showed the poorest performance. When considering lesions <20 mm, MIAB, but not EUS-FNB, showed significantly higher accuracy rates compared with EUS-FNA (RR 1.68 [95%CI 1.02-2.88]). Overall, MIAB ranked as the best intervention for lesions <20 mm (SUCRA score 0.86 for adequacy and 0.91 for accuracy), with EUS-FNB only slightly superior to EUS-FNA. When rapid on-site cytological evaluation (ROSE) was available, no difference between EUS-FNB, EUS-FNA, and MIAB was observed. CONCLUSION: EUS-FNB and MIAB appeared to provide better performance, whereas bite-on-bite sampling was significantly inferior to the other techniques. MIAB seemed to be the best option for smaller lesions, whereas EUS-FNA remained competitive when ROSE was available.

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.

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.

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.

Adverse Events of Endoscopic Clip Placement: A MAUDE Database Analysis.

BACKGROUND: Clips are endoscopic mechanical devices with tensile and closure strength that can approximate tissue and provide hemostasis through a tamponade effect. Clips are ubiquitously used in endoscopic practice, and numerous studies have validated the clinical efficacy of clips, with recent guidelines recommending them as a first-line intervention for recurrent and persistent nonvariceal gastrointestinal bleeding. However, the safety profile for these devices has yet to be delineated, thus, we aim to investigate this feature by examining the adverse events reported to the Food and Drug Administration. METHODS: Postmarketing surveillance data from the Food and Drug Administration Manufacturer And User Facility Device Experience database were analyzed from January 2012 to January 2021. The Manufacturer And User Facility Device Experience database is a reporting software and does not independently verify the details of complications. RESULTS: Two thousand five hundred forty reports were issued, of which 287 were patient adverse events and 2766 were device problems. Activation, separation, and positioning issues were most common. No consequences or clinically significant impact on patients were seen in 1968 reports. Foreign bodies were seen in 97 cases, hemorrhage in 57 cases, tissue damage in 42 cases, embedded clips in tissues/plaques in 16 cases, perforation in 15 cases, lacerations in 6 cases, and infection in 3 cases. CONCLUSIONS: While the most commonly reported device problems involved activation, separation, and positioning, most patients were clinically unaffected. Moreover, perforation and infection were exceedingly rare, further highlighting the safety profile of endoscopic clips.

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.

Outcomes of ERCP in Patients With Cystic Fibrosis: A Nationwide Inpatient Assessment.

BACKGROUND: Cystic fibrosis (CF) is a multisystem disorder that leads to abnormal transport of chloride and sodium across secretory epithelia resulting in thickened, viscous secretions in the bronchi, biliary tract, pancreas, intestine, and the reproductive system. Defects in the biliary tract can predispose to stone formation requiring endoscopic retrograde cholangiopancreatography (ERCP). However, there is a paucity of data assessing ERCP outcomes in patients with CF. METHODS: We identified patients from the Healthcare Cost and Utilization Project (HCUP)-National Inpatient Sample (NIS) between the years 2016 and 2020. Our study group included patients with CF of all ages who underwent an inpatient ERCP. We used ICD10 diagnostic and procedural codes to identify patients, procedures, and complications of the procedure. RESULTS: From 2016 to 2020, a total of 860,679 inpatient ERCPs were identified. Of these procedures, 535 (0.06%) were performed in patients with CF. The mean age of patients with CF undergoing ERCP was 60.62 years, of which 48% were males and 52% were females. Patients in the CF group had a higher incidence of post-ERCP pneumothorax (0.93%) than the patients in the non-CF group (0.15%). The occurrence of other ERCP-related adverse events was similar in both groups (P>0.05). On multivariate regression analysis, patients with CF were 1.75 times more likely to develop post-ERCP infections [odds ratio (OR): 1.75; 95% CI: 1.03-2.94; P=0.035) and 7.64 times more likely to develop post-ERCP pneumothorax (OR: 7.64; 95% CI: 1.03-56.5; P=0.046) compared to patients without CF after adjusting for confounders. The groups had no significant difference in mortality, post-ERCP pancreatitis, bleeding, perforation, pneumoperitoneum, and gas embolism. There was also no significant difference in the length of stay between the study and control groups. CONCLUSIONS: ERCP is a safe procedure in patients with CF with a comparable risk of postprocedural complications and mortality to those who do not have cystic fibrosis. However, patients with CF may experience a higher risk of post-ERCP infections and post-ERCP pneumothorax. Further studies are needed to prospectively evaluate outcomes of ERCP in patients with CF and to determine methods of mitigating adverse events.

Clinical outcomes and predictors for 30-day readmissions of endoscopic retrograde cholangiopancreatography in the United States.

BACKGROUND/OBJECTIVES: We aimed to assess 30-day readmissions of endoscopic retrograde cholangiopancreatography (ERCP) in the United States. METHODS: The National Readmission Database was utilized from 2016 to 2020 to identify 30-day readmissions of ERCP. Hospitalization characteristics and outcomes were compared between index hospitalizations and readmissions. Predictors of 30-day readmission and mortality were also identified. RESULTS: Between 2016 and 2020, 885 416 index hospitalizations underwent ERCP. Of these, 88 380 (10.15%) were readmitted within 30 days. Compared to index hospitalizations, 30-day readmissions had higher mean age (63.76 vs 60.8 years, P < 0.001) and proportion of patients with Charlson Comorbidity Index (CCI) score ≥3 (48.26% vs 29.91%, P < 0.001). Sepsis was the most common readmission diagnosis. Increasing age, male gender, higher CCI scores, admissions at large metropolitan teaching hospitals, cholecystectomy on index hospitalization, biliary stenting, increasing length of stay (LOS) at index admission, post-ERCP pancreatitis, post-ERCP hemorrhage, and gastrointestinal tract perforation were independent predictors of 30-day readmissions. Furthermore, 30-day readmissions had higher odds of inpatient mortality (4.42% vs 1.66%, aOR 1.9, 95% CI: 1.79-2.01, P < 0.001) compared to index hospitalizations. However, we noted a shorter LOS (5.78 vs 6.22 days, mean difference 1.2, 95% CI: 1.12-1.28, P < 0.001) and lower total hospital charge ($71 076 vs $93 418, mean difference $31 452, 95% CI: 29 835-33 069, P < 0.001) for 30-day readmissions compared to index hospitalizations. Increasing age, higher CCI scores, increasing LOS, biliary stenting, and post-ERCP hemorrhage were independent predictors of inpatient mortality for 30-day readmissions. CONCLUSION: After index ERCP, the 30-day remission rate was 10.15%. Compared to index hospitalizations, 30-day readmissions had higher odds of inpatient mortality.

Advanced trainee perceptions of disposable duodenoscopes and disposable endcaps: results of a nationwide survey.

INTRODUCTION: Disposable duodenoscopes and duodenoscopes with disposable endcaps are being used in clinical practice to reduce or eliminate the risk of transmitting infections. The study aim was to assess perceptions and experiences regarding the use of these duodenoscopes among advanced endoscopy fellows in a nationally representative sample. METHODS: A 17-item electronic survey was sent to 74 advanced endoscopy training programs. The survey was completed by 50 participants and their responses were included for analysis. RESULTS: Most participants were from academic training programs (82.7%) and identified as being in their 7th year of post graduate training (92%; PGY-7). Participants performed an average of 414 ERCPs. 29% reported difficulty with cannulation using disposable duodenoscopes versus 15.7% with duodenoscopes with disposable endcaps (vs. standard duodenoscope). 96% of trainees perceived disposable duodenoscopes as not cost effective and 92% stated they would not use this device during independent practice. 100% of trainees stated that they would use duodenoscopes with disposable endcaps during independent practice. For their most challenging cases, 90% of trainees preferred using standard reprocessable duodenoscopes while no trainee indicated they would prefer using a disposable duodenoscope in this scenario. 82% of participants stated that disposable duodenoscopes and disposable endcaps should be used exclusively or preferentially for high-risk patients citing cost, functionality, and concerns regarding environmental impact. DISCUSSION: Advanced endoscopy fellows perceive disposable duodenoscopes as impacting technical maneuverability. Concerns about functionality, cost effectiveness and environmental impact are barriers to adoption.

Epidemiology and Socioeconomic Impact of Pancreatic Cancer: An Analysis of the Global Burden of Disease Study 1990-2019.

INTRODUCTION: The aim of this study is to estimate the global burden of pancreatic cancer from 1990 to 2019. METHODS: We reconstructed the Global Burden of Diseases (GBD) study results for pancreatic cancer across 204 countries and territories. Our study generated estimates for key disease burden indicators, including incidence, prevalence, mortality, and disability-adjusted life years (DALYs), and cost. Linear regression analysis of the natural logarithm of age-standardized outcomes was used to calculate annual percent change. RESULTS: In 2019, there were a total of 530,296 incident and 442,101 prevalent cases of pancreatic cancer, resulting in 531,107 deaths and 11.5 million DALYs lost. The age-standardized incidence and prevalence of pancreatic cancer has increased from 5.22 (95% CI 4.97-5.40) to 6.57 (CI 6.00-7.09) per 100,000 people per year, and 4.1 (95% CI 3.95-4.26) to 5.4 (CI 4.96-5.87), respectively. This equated to 10 million (95% CI 9.5 to 10.4 million) incident cases of pancreatic cancer. The number of DALYs lost as a result of pancreatic cancer was 225 million years (95% CI 216-234 million years). Mortality from pancreatic cancer increased over the study period from 3.7 (95% CI 3.54-3.83) to 6.9 (95% CI 6.36-7.32). Incidence, prevalence, DALYs, and mortality were higher in countries with a higher socio-demographic index. CONCLUSIONS: Pancreatic cancer is rising around the world and is associated with a high economic burden. Programs aimed at reducing modifiable risk factors are needed.

The impact of COVID-19 on hospitalizations that underwent endoscopic retrograde cholangiopancreatography in the United States.

BACKGROUND/OBJECTIVES: COVID-19 impacts technical success of endoscopic retrograde cholangiopancreatography (ERCP). In this study, we aimed to assess the influence of COVID-19 on hospitalizations that underwent ERCP. METHODS: We identified all adult COVID-19 and non-COVID-19 hospitalizations that underwent ERCP in the United States using the National Inpatient Sample for 2020. Hospitalization characteristics, clinical outcomes, and complications were compared between the two groups. RESULTS: In 2020, 2015 COVID-19 and 203,094 non-COVID-19 hospitalizations underwent ERCP. The COVID-19 cohort had a higher mean age (60.3 vs 55.6 years, p < 0.001) and a higher proportion of Blacks and Hispanics compared to the non-COVID-19 cohort. After adjusting for confounders, the COVID-19 cohort had higher all-cause inpatient mortality (4.77 vs 1.45%, aOR 4.09, 95% CI 2.50-6.69, p < 0.001), mean length of stay (LOS) [10.19 vs 5.94 days, mean difference: 3.88, 95% CI 2.68-5.07, p < 0.001] and mean total hospital charges (THC) [$152,933 vs $96,398, mean difference: 46,367, 95% CI 21,776-70,957, p < 0.001] compared to the non-COVID-19 cohort. Increasing age, higher Charlson Comorbidity Index, and post-ERCP pancreatitis were identified to be independent predictors of inpatient mortality for COVID-19 hospitalizations that underwent ERCP. Furthermore, the COVID-19 cohort had higher odds of developing post-ERCP pancreatitis (PEP) (11.55 vs 7.05%, aOR 1.64, 95% CI 1.19-2.25, p = 0.002) compared to the non-COVID-19 cohort, after adjusting for confounders. However, there was no statistical difference in the rates of bowel perforations and post-ERCP hemorrhage between the two groups. CONCLUSION: COVID-19 hospitalizations that underwent ERCP had higher inpatient mortality, mean LOS, mean THC, and odds of developing PEP compared to the non-COVID-19 cohort. CLINICAL TRIAL REGISTRATION: This study is not a part of a clinical trial.

Effectiveness and safety of stag beetle knife (SB knife) in management of Zenker's diverticulum: a systematic review and meta-analysis.

Stag Beetle Knife (SB Knife) is increasingly being utilized for Zenker's Diverticulectomy (ZD). Our study assessed the effectiveness and safety of the SB Knife for the management of ZD. Ovid EBM reviews, Ovid Embase, Ovid Medline, ClinicalTrials.gov, Scopus, and Web of Science were searched to identify studies that utilized SB knife for ZD. Pooled proportions (PP) were calculated using the random-effects model. Heterogeneity was evaluated using I2 statistics. A total of 7 studies with 268 patients were included in the final analysis. Dysphagia and regurgitation were the most common clinical symptoms. The mean size of the ZD was 2.8 ± 0.7 cm and 28 (of 148) patients had undergone previous treatments. The PP of technical success was 98% (95% CI: 92.3-99.5; I20) with a mean procedure duration of 26.2 ± 8.3 minutes. The PP of clinical response at first follow-up and relapse after index procedure was 87.9% (95% CI: 81.6-92.3; I219) and 13.5% (95% CI: 9.6-18.6; I22), respectively. At final follow-up, the PP of clinical remission was 96.2% (95% CI: 91-98.4; I230.6) while the PP of procedure failure was 3.6% (95% CI: 1.6-8.1; I20). No severe adverse events (AEs) were noted while using the SB Knife. However, the PP of intraprocedural and postprocedural AEs was 13.2% (95% CI: 9.6-17.8; I20) and 9.3% (95% CI: 5.7-14.9; I2 < 20.9), respectively. SB Knife is highly safe and effective for Zenker's Diverticulectomy with a failure rate of only 3.6%.

Diagnostic accuracy of convolutional neural network-based machine learning algorithms in endoscopic severity prediction of ulcerative colitis: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Endoscopic assessment of ulcerative colitis (UC) can be performed by using the Mayo Endoscopic Score (MES) or the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). In this meta-analysis, we assessed the pooled diagnostic accuracy parameters of deep machine learning by means of convolutional neural network (CNN) algorithms in predicting UC severity on endoscopic images. METHODS: Databases including MEDLINE, Scopus, and Embase were searched in June 2022. Outcomes of interest were the pooled accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Standard meta-analysis methods used the random-effects model, and heterogeneity was assessed using the I2statistics. RESULTS: Twelve studies were included in the final analysis. The pooled diagnostic parameters of CNN-based machine learning algorithms in endoscopic severity assessment of UC were as follows: accuracy 91.5% (95% confidence interval [CI], 88.3-93.8; I2 = 84%), sensitivity 82.8% (95% CI, 78.3-86.5; I2 = 89%), specificity 92.4% (95% CI, 89.4-94.6; I2 = 84%), PPV 86.6% (95% CI, 82.3-90; I2 = 89%), and NPV 88.6% (95% CI, 85.7-91; I2 = 78%). Subgroup analysis revealed significantly better sensitivity and PPV with the UCEIS scoring system compared with the MES (93.6% [95% CI, 87.5-96.8; I2 = 77%] vs 82% [95% CI, 75.6-87; I2 = 89%], P = .003, and 93.6% [95% CI, 88.7-96.4; I2 = 68%] vs 83.6% [95% CI, 76.8-88.8; I2 = 77%], P = .007, respectively). CONCLUSIONS: CNN-based machine learning algorithms demonstrated excellent pooled diagnostic accuracy parameters in the endoscopic severity assessment of UC. Using UCEIS scores in CNN training might offer better results than the MES. Further studies are warranted to establish these findings in real clinical settings.

Risk of post-sphincterotomy bleeding with antiplatelet and anticoagulant use: a propensity-matched analysis of the U.S. Collaborative Network.

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/m2, 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.

Single-incision needle-knife biopsy for the diagnosis of GI subepithelial tumors: a systematic review and meta-analysis.

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; I2 = .0%), and the diagnostic success rate was 87.9% (95% CI, 82.6%-91.7%; P = .000; I2 = .0%). The immunohistochemical success rate was 88.3% (95% CI, 78.7%-93.9%; P = .000; I2 = 3.5%). The rate of adverse events was 7.5% (95% CI, 4.3%-12.7%; P = .00; I2 = 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.

Early (<4 weeks) versus standard (≥4 weeks) endoscopic drainage of pancreatic walled-off fluid collections: a systematic review and meta-analysis.

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.

Utilization of Hepatocellular Carcinoma Surveillance Programs in Patients With Cirrhosis: A Systematic Review and Meta-Analysis.

Patients with cirrhosis are advised to undergo hepatocellular carcinoma (HCC) surveillance every 6 months. Routine surveillance is associated with early tumor detection and improved survival. However, surveillance is underutilized. We aimed to characterize the uptake of HCC surveillance in cirrhotic patients following the implementation of interventional programs. We performed a comprehensive literature search of major databases (from inception to October 2020). Surveillance was defined as having an abdominal sonogram every 6 months. Nine studies were included for meta-analysis which involved 4550 patients. The etiology of liver cirrhosis was largely due to hepatitis C or B (n=2023), followed by alcohol (n=857), and nonalcoholic steatohepatitis (n=432). Patients enrolled in surveillance programs were 6 times more likely to undergo abdominal sonography when compared with standard of care (odds ratio=6.00; 95% confidence interval: 3.35-10.77). On subgroup analysis, clinical reminders were associated with a 4 times higher rate of HCC surveillance compared with standard of care (odds ratio=3.80; 95% confidence interval: 2.25-6.39). Interventional programs significantly improve the rate of HCC surveillance. This is clinically impactful and should be considered as a means for improving surveillance rates.

Role of Duodenal Bulb Biopsy in Diagnosing Suspected Celiac Disease in Adult Patients: A Systematic Review and Meta-analysis.

BACKGROUND AND AIMS: Current guidelines recommend multiple biopsies from the first (D1) and second (D2) part of duodenum to establish a diagnosis of celiac disease. In this meta-analysis we aimed to find whether D1 biopsy can increase the diagnostic yield of adult celiac disease. METHODS: Literature databases were searched until January 2023 for studies reporting diagnosis of celiac disease in the adult population using D1 biopsy. Meta-analysis was done using a random-effects model. Heterogeneity was assessed by I2% and 95% prediction interval statistics. Measured outcomes were diagnostic yield with D1 and D2 biopsies and from 4 versus 2 biopsy samples. RESULTS: A total of 16 studies were included in the final analysis. The pooled diagnostic rate of celiac disease from D1 biopsy was 77.4% [95% CI (64.7-86.5, I2 94%)] and from D2 biopsy was 75.3% [60.8-85.7, I2 96%]. The pooled rate of increase in diagnostic yield with D1 biopsy was 6.9% I [4.6-10.2, I2 66%]. The pooled diagnosis rate with 2 biopsy samples were 77.3% [50-92, I2 93%] and 86.4% I [58.4-96.7, I2 87%] from D1 and D2 respectively, whereas that with 4 biopsy samples were 83.3% [49.8-96.2, I2 76%] and 70.5% I [51-84.6, I2 96%] from D1 and D2, respectively, the difference being non-significant. CONCLUSION: Our study demonstrates that taking 4 biopsy samples does not incur any additional diagnostic value over taking 2 biopsy samples from each duodenum segment. Although biopsy from the D1 and D2 has similar diagnostic yield in the adult population, there was an overall increase in diagnostic yield with D1 biopsy, especially in those with a patchy disease distribution.

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.