Peetermans, Joyce

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.

Objective: To evaluate the safety and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS). Background: For patients with acute cholecystitis who are poor surgical candidates, EUS-GBD using a LAMS is an important treatment alternative to percutaneous gallbladder drainage. Methods: We conducted a regulatory-compliant, prospective multicenter trial at 7 tertiary referral centers in the United States of America and Belgium. Thirty consecutive patients with mild or moderate acute cholecystitis who were not candidates for cholecystectomy were enrolled between September 2019 and August 2021. Eligible patients had a LAMS placed transmurally with 30 to 60-day indwell if removal was clinically indicated, and 30-day follow-up post-LAMS removal. Endpoints included days until acute cholecystitis resolution, reintervention rate, acute cholecystitis recurrence rate, and procedure-related adverse events (AEs). Results: Technical success was 93.3% (28/30) for LAMS placement and 100% for LAMS removal in 19 patients for whom removal was attempted. Five (16.7%) patients required reintervention. Mean time to acute cholecystitis resolution was 1.6±1.5 days. Acute cholecystitis symptoms recurred in 10.0% (3/30) after LAMS removal. Five (16.7%) patients died from unrelated causes. Procedure-related AEs were reported to the FDA in 30.0% (9/30) of patients, including one fatal event 21 days after LAMS removal; however, no AEs were causally related to the LAMS. Conclusions: For selected patients with acute cholecystitis who are at elevated surgical risk, EUS-GBD with LAMS is an alternative to percutaneous gallbladder drainage. It has high technical and clinical success, with low recurrence and an acceptable AE rate. Clinicaltrials.gov, Number: NCT03767881.

Abstract Background and study aims Lumen-apposing metal stents (LAMS) are increasingly used for drainage of walled-off pancreatic necrosis (WON). Recent studies suggested greater adverse event (AE) rates with LAMS for WON. We conducted a systematic review and meta-analysis to compare the safety and efficacy of LAMS with double-pigtail plastic stents (DPPS) for endoscopic drainage of WON. The primary aim was to evaluate stent-related AEs. Methods In October 2019, we searched the Ovid (Embase, MEDLINE, Cochrane) and Scopus databases for studies assessing a specific LAMS or DPPS for WON drainage conducted under EUS guidance. Safety outcomes were AE rates of bleeding, stent migration, perforation, and stent occlusion. Efficacy outcomes were WON resolution and number of procedures needed to achieve resolution. A subanalysis including non-EUS-guided cases was performed. Results Thirty studies including one randomized controlled trial (total 1,524 patients) were analyzed. LAMS were associated with similar bleeding (2.5 % vs. 4.6 %, P = 0.39) and perforation risk (0.5 % vs. 1.1 %, P = 0.35) compared to DPPS. WON resolution (87.4 % vs. 87.5 %, P = 0.99), number of procedures to achieve resolution (2.09 vs. 1.88, P = 0.72), stent migration (5.9 % vs. 6.8 %, P = 0.79), and stent occlusion (3.8 % vs. 5.2 %, P = 0.78) were similar for both groups. Inclusion of non-EUS-guided cases led to significantly higher DPPS bleeding and perforation rates. Conclusions LAMS and DPPS were associated with similar rates of AEs and WON resolution when limiting analysis to EUS-guided cases. Higher bleeding rates were seen in historical studies of DPPS without EUS guidance. Additional high-quality studies of WON treatment using consistent outcome definitions are needed.

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.