Citations

INTRODUCTION: Prophylactic pancreatic stent placement (PSP) is effective for preventing pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk cases, but the optimal technical approach to this intervention remains uncertain. METHODS: In this secondary analysis of 787 clinical trial patients who underwent successful stent placement, we studied the impact of (i) whether pancreatic wire access was achieved for the sole purpose of PSP or naturally during the conduct of the case, (ii) the amount of effort expended on PSP, (iii) stent length, (iv) stent diameter, and (v) guidewire caliber. We used logistic regression models to examine the adjusted association between each technical factor and post-ERCP pancreatitis (PEP). RESULTS: Ninety-one of the 787 patients experienced PEP. There was no clear association between PEP and whether pancreatic wire access was achieved for the sole purpose of PSP (vs occurring naturally; odds ratio [OR] 0.82, 95% confidence interval [CI] 0.37–1.84), whether substantial effort expended on stent placement (vs nonsubstantial effort; OR 1.58, 95% CI 0.73–3.45), stent length (>5 vs ≤5 cm; OR 1.01, 95% CI 0.63–1.61), stent diameter (≥5 vs <5 Fr; OR 1.13, 95% CI 0.65–1.96), or guidewire caliber (0.035 vs 0.025 in; 0.83, 95% CI 0.49–1.41). DISCUSSION: The 5 modifiable technical factors studied in this secondary analysis of large-scale randomized trial data did not appear to have a strong impact on the benefit of prophylactic PSP in preventing PEP after high-risk ERCP. Within the limitations of post hoc subgroup analysis, these findings may have important implications in procedural decision making and suggest that the benefit of PSP is robust to variations in technical approach.

Background The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. Methods 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). Results Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3–4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis. Conclusions In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.

BACKGROUND: Bim (BCL-2-interacting mediator of cell death) is a downstream pro-apoptotic signaling molecule activated by the PD-1 pathway. OBJECTIVE: We sought to determine if Bim expression in peritumoral T-lymphocytes (PTLs) is associated with survival in patients with metastatic clear cell renal cell carcinoma (ccRCC). METHODS: Immunohistochemistry staining for Bim was performed on paraffin-embedded tumor tissue blocks from patients with metastatic ccRCC who underwent nephrectomy between 1990-2004. Associations of Bim expression with cancer-specific survival (CSS) and overall survival (OS) from date of metastasis were evaluated using multivariable Cox regression models, adjusting for age, sex, and metastases-score. RESULTS: 525 patients with metastatic ccRCC, of whom 169 (32%) had metastases at time of nephrectomy were studied. After multivariable adjustment, high Bim expression remained associated with worse CSS (HR = 1.31; 95% CI 1.07–1.59; p = 0.008) and OS (HR = 1.28; 95% CI 1.06–1.55; p = 0.01). The interaction between Bim and PD-L1 was not statistically significant for CSS ( p = 0.68) or OS ( p = 0.57), suggesting that the associations between Bim and survival outcomes were not significantly different based on tumor PD-L1 expression. CONCLUSION: High Bim expression in PTLs at nephrectomy is prognostic of worse CSS and OS in patients with metastatic ccRCC, irrespective of tumor PD-L1 expression. The role of earlier PD-1/PD-L1-directed therapy warrants evaluation in these patients.

Summary Peroral endoscopic myotomy (POEM) in patients with achalasia who are status post bariatric surgery may be technically challenging due to postsurgical scarring and altered anatomy. The aim of the study was to assess the efficacy and safety of POEM for achalasia in patients with prior bariatric surgery. A review of prospectively maintained databases at three tertiary referral centers from January 2015 to January 2021 was performed. The primary outcome of interest was clinical success, defined as a post-treatment Eckardt score ≤ 3 or improvement in Eckardt score by ≥ 1 when the baseline score was &lt;3, and improvement of symptoms. Secondary outcomes were adverse event rates and symptom recurrence. Sixteen patients status post Roux-en-Y gastric bypass (n = 14) and sleeve gastrectomy (n = 2) met inclusion criteria. Indications for POEM were achalasia type I (n = 2), type II (n = 9), and type III (n = 5). POEM was performed either by anterior or posterior approach. The pre-POEM mean integrated relaxation pressure was 26.2 ± 7.6 mm Hg. The mean total myotomy length was 10.2 ± 2.7 cm. The mean length of hospitalization was 1.4 ± 0.7 days. Pre- and postprocedure Eckardt scores were 6.1 ± 2.1 and 1.7 ± 1.8, respectively. The overall clinical success rate was 93.8% (15/16) with mean follow-up duration of 15.5 months. One patient had esophageal leak on postprocedure esophagram and managed endoscopically. Dysphagia recurred in two patients, which was successfully managed with pneumatic dilation with or without botulinum toxin injection. POEM appears to be safe and effective in the management of patients with achalasia who have undergone prior bariatric surgery.

Background: Endoscopic ultrasound–guided rendezvous (EUS-RV) endoscopic retrograde cholangiopancreatography (ERCP) is an alternative to interventional radiology–guided rendezvous ERCP in patients who failed biliary cannulation with conventional ERCP. However, there is significant variation in reported rates of success and adverse events associated with EUS-RV-assisted ERCP. We performed a systematic review and a proportion meta-analysis to reliably assess the effectiveness and safety of the EUS-RV-assisted ERCP. Materials and Methods: We conducted a comprehensive search of multiple electronic databases and conference proceedings (from inception through August 2020) to identify studies reporting EUS-RV-assisted ERCP in patients who failed biliary cannulation with conventional ERCP techniques. Using the random-effects model described by DerSimonian and Laird, we calculated the pooled rates of technical success, clinical success, and adverse events of EUS-RV-assisted ERCP. Results: Twelve studies reporting a total of 342 patients were included in the meta-analysis. The pooled rate of technical success (12 studies reporting a total of 342 patients) was 86.1% [95% confidence interval (CI): 78.4-91.3]. The pooled rate of clinical success (4 studies reporting a total of 94 patients) was 80.8% (95% CI: 64.1-90.8). The pooled rate of overall adverse events (12 studies; 42 events in 342 patients) was 14% (95% CI: 10.5-18.4). Low to moderate heterogeneity was noted in the analyses. Conclusions: EUS-RV-assisted ERCP appears to be effective and safe in patients who failed biliary cannulation with conventional ERCP. Given the risk of adverse events, it should be performed in centers with expertise in therapeutic endoscopic ultrasound.

AbstractBackground Endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y gastric bypass (RYGB) anatomy is challenging. Overtube-assisted enteroscopy (OAE) is usually needed to perform ERCP in these patients. There is significant variation in the reported rates of success and adverse events across published studies. We performed a systematic review and meta-analysis to reliably estimate the pooled rates of success and adverse events.Methods We performed a systematic search of multiple electronic databases through February 2020 to identify studies reporting outcomes of OAE-ERCP in post-RYGB patients. The pooled rates of enteroscopy success, technical success, and adverse events were estimated for OAE-ERCP. The pooled rates of success and adverse events were also estimated for ERCP using double-balloon enteroscopes (DBE) alone.Results 10 studies reporting a total of 398 procedures were included in the meta-analysis. The pooled rates of enteroscopy and technical success of OAE-ERCP were 75.3 % (95 % confidence interval [CI] 64.5 – 83.6) and 64.8 % (95 %CI 53.1 – 74.9) respectively. The pooled rate of adverse events was 8.0 % (95 %CI 5.2 – 12.2). The pooled rates of enteroscopy and technical success of DBE-ERCP (four studies) were 83.5 % (95 %CI 68.3 – 92.2) and 72.5 % (95 %CI 52.3 – 86.4), respectively. The pooled rate of adverse events with DBE-ERCP was 9.0 % (95 %CI 5.4 – 14.5). Substantial heterogeneity was noted.Conclusions OAE-ERCP appears to be effective and safe in post-RYGB patients. Among the currently available techniques, OAE-ERCP is the least invasive approach in this challenging group of patients. Future studies comparing the effectiveness and safety of alternative novel techniques, such as endosonography-directed transgastric ERCP, with OAE-ERCP are needed.

INTRODUCTION: In patients with acute cholecystitis who were deemed high risk for cholecystectomy, percutaneous cholecystostomy (PC) was historically performed for decompression of the gallbladder. There are several limitations associated with PC. Endoscopic gallbladder drainage [Endoscopic trans-papillary gallbladder drainage (ET-GBD) via ERCP and EUS-guided gallbladder drainage (EUS-GBD)] is an alternative to PC. We performed a systematic review and meta-analysis to compare the outcomes between the two endoscopic techniques (EUS-GBD vs ET-GBD). METHODS: We performed a systematic search of multiple databases through May 2019 to identify studies that compared outcomes of EUS-GBD versus ET-GBD in management of acute cholecystitis in high risk surgical patients. Pooled odds ratios (OR) of technical success, clinical success and adverse events between EUS-GBD and ET-GBD groups were calculated. RESULTS: Five comparative studies with a total of 861 patients; were included in the analysis. The pooled OR for technical success of EUS-GBD in comparison to ET-GBD was 5.22 (95% CI: 2.03-13.44; P = 0.01; I 2 = 20%). The pooled OR for clinical success (EUS-GBD vs ET-GBD) in intention-to-treat analysis was 4.16 (95% CI: 2.00-8.66; P = 0.001; I 2 = 19%) and per-protocol analysis was 1.81 (95% CI: 0.80-4.09; P = 0.15; I 2 =0%). The pooled OR for overall acute adverse events (EUS-GBD vs ET-GBD) was 1.32 (95% CI: 0.78 -2.25; P = 0.31, I 2 = 0%). The pooled OR for perforation and pancreatitis (EUS-GBD vs ETGBD) were 1.98 (95% CI: 0.32-12.29) and 0.19 (95% CI: 0.03-0.99) respectively. The pooled OR for recurrent cholecystitis (EUS-GBD vs ETGBD) was 0.33 (95% CI: 0.13-0.82). There was minimal heterogeneity in the analysis. CONCLUSION: EUS-GBD is associated with higher rate of technical and clinical success compared to ET-GBD. While the rate of overall acute adverse events are statistically similar between the two techniques, EUS-GBD is associated with lower rate of recurrent cholecystitis. In centers with expertise in EUS, EUS-GBD could be considered as first-line treatment in carefully selected patients.

INTRODUCTION: Endoscopic ultrasound (EUS) guided gastroenterostomy (GE) is emerging as an alternative to enteral stenting and surgical GE for management of malignant gastric outlet obstruction (GOO). With advances in EUS technology and availability of dedicated devices/stents for EUS scopes, the use of EUS-GE is expected to increase in the future. We performed a systematic review and meta-analysis to estimate the success rate and adverse events associated with EUS-GE. METHODS: We conducted a comprehensive search of multiple electronic databases and conference proceedings including PubMed, EMBASE, and Web of Science databases (from inception through May 2019) to identify studies that reported success rate and adverse events of EUS-GE. The primary outcome was to estimate the pooled rates of technical and clinical success of EUS-GE. The secondary outcome was to estimate the rate of adverse events. RESULTS: 9 studies with a total of 268 patients were included. The pooled rate of technical success of EUS-GE was 91.7 % (95% CI 87.5 – 94.5; I2 = 0). The pooled rate of clinical success of EUS-GJ was 87.8% (95% CI 83.1 – 91.3; I 2 = 0). The pooled rate of overall adverse events was 12.6% (95% CI 9.0- 17.6; I 2 = 0). The pooled rate of individual adverse events – perforation, bleeding, peritonitis and stent migration / misdeployment were 2% (95% CI 0.7 – 5.1), 3.2% (95% CI 1.5 – 6.5), 2.6% (95% CI 1.1-6.1) and 8.9 % (95% CI 4.3-17.5) respectively.The rate of surgical intervention for adverse events was 2%. CONCLUSION: While the rates of technical success (92%) and clinical success (88%) of EUS-GJ is promising, the risk of adverse events is considerable at 12.6%, with stent misdeployment (9%) being the most common adverse event. Hence, EUS-GJ should be performed at tertiary referral centers in a multidisciplinary (surgery, oncology, gastroenterology) team-based approach.

INTRODUCTION: Exogenous transmission of infection via duodenoscope cross-contamination after failed disinfection is a preventable risk. Inadequate reprocessing of reusable duodenoscopes can occur. Given this possibility, a new single-use duodenoscope was recently developed. It had comparable performance to reusable duodenoscopes when tested by expert endoscopists in a comparative bench model for endoscopic retrograde cholangiopancreatography (ERCP). We subsequently aimed to assess the performance of this disposable duodenoscope in a series of human cases. METHODS: Six academic medical centers enrolled consecutive adults 18 years or older without altered pancreaticobiliary anatomy scheduled for an ERCP. Seven ERCP experts rated the new EXALT single-use Model D duodenoscope (Boston Scientific, Marlborough, MA; ClinicalTrials.gov NCT03701958) in ERCP procedures for Overall Satisfaction on a scale of 1 (unsatisfied) to 10 (very satisfied), “Not preferred/Neutral/Preferred” compared to reusable duodenoscopes on 23 ERCP maneuvers, and Qualitative Comparison of 17 performance characteristics on a scale of 1 (not preferred) to 5 (comparable to reusable duodenoscopes). RESULTS: Sixty consecutive patients had an ERCP using the first-generation single-use duodenoscope in April and May 2019. Thirty-seven (61.7%) were male, mean age was 64.4 years, and 44 (73.3%) had a prior ERCP at baseline. All 60 ERCP procedures were successfully performed, 58 (96.7%) with the single-use duodenoscope alone and 2 (3.3%) with crossover to a reusable duodenoscope. Median overall satisfaction with the single-use duodenoscope was rated 9.0 (range 1-10). The overall satisfaction rating was ≥ 7 in 56 (93.3%) ERCPs. All three ratings were at or above midpoint (Overall satisfaction ≥ 5, Comparative ERCP maneuver “Neutral/Preferred,” Qualitative Comparative rating of performance characteristic 3-5) in 47 (78.3%) cases. Four ERCPs had low (≤4) overall satisfaction ratings attributed to inadequate pushability of instruments due to suboptimal positioning of the duodenoscope in front of the papilla; these ERCPs were a subset in which biliary or pancreatic duct strictures were dilated and/or stented. CONCLUSION: Expert endoscopists reported good overall performance of a new single-use duodenoscope in a broad array of cases. Low ratings occurred rarely and were associated with particular ERCP maneuvers. Detailed design improvements to the single-use duodenoscope are underway.

INTRODUCTION: Detailed recommendations and guidelines for acute pancreatitis (AP) management currently exist. However, quality indicators (QIs) are required to measure performance in health care. The goal of the Acute Pancreatitis Task Force on Quality was to formally develop QIs for the management of patients with known or suspected AP using a modified version of the RAND/UCLA Appropriateness Methodology. METHODS: A multidisciplinary expert panel composed of physicians (gastroenterologists, hospitalists, and surgeons) who are acknowledged leaders in their specialties and who represent geographic and practice setting diversity was convened. A literature review was conducted, and a list of proposed QIs was developed. In 3 rounds, panelists reviewed literature, modified QIs, and rated them on the basis of scientific evidence, bias, interpretability, validity, necessity, and proposed performance targets. RESULTS: Supporting literature and a list of 71 proposed QIs across 10 AP domains (Diagnosis, Etiology, Initial Assessment and Risk Stratification, etc.) were sent to the expert panel to review and independently rate in round 1 (95% of panelists participated). Based on a round 2 face-to-face discussion of QIs (75% participation), 41 QIs were classified as valid. During round 3 (90% participation), panelists rated the 41 valid QIs for necessity and proposed performance thresholds. The final classification determined that 40 QIs were both valid and necessary. DISCUSSION: Hospitals and providers managing patients with known or suspected AP should ensure that patients receive high-quality care and desired outcomes according to current evidence-based best practices. This physician-led initiative formally developed 40 QIs and performance threshold targets for AP management. Validated QIs provide a dependable quantitative framework for health systems to monitor the quality of care provided to patients with known or suspected AP.