Global prospective case series of ERCPs using a single-use duodenoscope.

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.

Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial.

OBJECTIVE: We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection. SUMMARY BACKGROUND DATA: Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON. DESIGN: We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound -guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥6 cm in diameter with >30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events. RESULTS: Forty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths. CONCLUSIONS: Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808.

Endoscopic Ultrasound-guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis: A Prospective Multicenter Trial.

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.

Soft self-expandable metal stent to treat painful pancreatic duct strictures secondary to chronic pancreatitis: a prospective multicenter trial.

BACKGROUND AND AIMS: Fully covered self-expandable metal stents (FCSEMSs) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection and FCSEMS design, efficacy, and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain. METHODS: Patients with painful CP, a dominant distal PD stricture, and PD dilation upstream were enrolled in a prospective, multicenter, single-arm trial studying 6-month indwell of a 4- to 6-cm-long soft pancreatic FCSEMS. Primary efficacy and safety endpoints were pain reduction 6 months after FCSEMS indwell (performance goal ≥53%) and PD stenting-related serious adverse events (SAEs), respectively (performance goal <32%). The primary efficacy endpoint was assessed in patients with sufficiently severe and frequent pain at FCSEMS placement as a first stent or in exchange of a plastic stent. RESULTS: Among 67 patients (mean age, 52.7 ± 12.5 years; mean time since CP diagnosis, 6.4 ± 6.4 years), 34 (50.7%) had plastic stent placement within 90 days of FCSEMS placement, and 46 patients were eligible for the primary efficacy endpoint analysis. Technical success was 97.0% (65/67). The observed primary efficacy (26.1%, 12/46) and safety endpoints (31.3%, 21/67) failed to meet the a priori study hypotheses. Study stent migration occurred in 47.7% of patients (31/65). CONCLUSIONS: Six-month treatment with an FCSEMS did not lead to an expected degree of pain reduction, and migrations and SAEs were common. Further study is needed to clarify optimal decompressive strategy, FCSEMS design, and patient selection. (Clinical trial registration number: NCT02802020.).

Feasibility of a new bariatric fully endoscopic duodenal-jejunal bypass: a pilot study in adult obese pigs.

This study assessed a new natural orifice transluminal endoscopic surgery (NOTES) bariatric endoscopic procedure in obese adult pigs. This 14-week prospective study compared 6 adult male Yucatan test pigs with baseline mean age 1.5 years to 2 control pigs. The test pigs received a fully endoscopic NOTES-based duodenal-jejunal bypass including measurement of the bypassed limb and creation of a gastrojejunal anastomosis (GJA) using a gastrojejunal lumen-apposing metal stent (GJ-LAMS) at Week 0, placement of a duodenal exclusion device (DED) at Week 2, and endoscopic examinations at Weeks 6 and 10. At Week 14, the pigs were sacrificed for necropsy. All endoscopic procedures were technically successful. By Week 14, the controls had gained a mean 1.1 ± 2.1 kg (+ 1.6%) while the intervention animals lost a mean 6.8 ± 3.9 kg (- 10.5%) since baseline. GJ-LAMS migrations occurred in 3 pigs, two of which also had DED migration and/or partial dislocation. Two other pigs died, one with aberrant splenic vein positioning near the GJA and the other from an unknown cause. An endoscopic bariatric bypass procedure with controlled bypass length was technically successful in all the cases and led to weight loss in test animals. Safety concerns must be further addressed.

Efficacy and safety of endoscopic duodenal stent versus endoscopic or surgical gastrojejunostomy to treat malignant gastric outlet obstruction: systematic review and meta-analysis.

Background and study aims Malignant disease accounts for up to 80 % of gastric outlet obstruction (GOO) cases, which may be treated with duodenal self-expanding metal stents (SEMS), surgical gastrojejunostomy (GJ), and more recently endoscopic-ultrasound-guided gastroenterostomy (EUS-GE). These three treatments have not been compared head-to-head in a randomized trial. Methods We searched the Embase and MEDLINE databases for studies published January 2015-February 2021 assessing treatment of malignant GOO using duodenal SEMS, endoscopic (EUS-GE) or surgical (laparoscopic or open) GJ. Efficacy outcomes assessed included technical and clinical success rates, GOO recurrence and reintervention. Safety outcomes included procedure-related bleeding or perforation, and stent-related events for the duodenal SEMS and EUS-GE arms. Results EUS-GE had a lower rate of technical success (95.3%) than duodenal SEMS (99.4 %) or surgical GJ (99.9%) ( P  = 0.0048). For duodenal SEMS vs. EUS-GE vs. surgical GJ, rates of clinical success (88.9 % vs. 89.0 % vs. 92.3 % respectively, P  = 0.49) were similar. EUS-GE had a lower rate of GOO recurrence based on limited data ( P  = 0.0036), while duodenal SEMS had a higher rate of reintervention ( P  = 0.041). Overall procedural complications were similar (duodenal SEMS 18.7 % vs. EUS-GE 21.9 % vs. surgical GJ 23.8 %, P  = 0.32), but estimated bleeding rate was lowest ( P  = 0.0048) and stent occlusion rate was highest ( P  = 0.0002) for duodenal SEMS. Conclusions Duodenal SEMS, EUS-GE, and surgical GJ showed similar clinical efficacy for the treatment of malignant GOO. Duodenal SEMS had a lower procedure-related bleeding rate but higher rate of reintervention.

Feasibility of Conversion of a New Bariatric Fully Endoscopic Bypass Procedure to Bariatric Surgery: a Porcine Pilot Study.

PURPOSE: Bariatric endoscopic procedures are emerging as alternatives to bariatric surgical procedures. This study aimed to assess if a natural orifice transluminal endoscopic surgery (NOTES) bariatric procedure could be converted to a surgical duodenal-jejunal bypass (DJB) or sleeve gastrectomy (SG). MATERIALS AND METHODS: This 12-week prospective study compared 4 test pigs to 3 control (no procedures) pigs aged 3 months at baseline. The test pigs received a fully endoscopic NOTES-based bypass including measurement of the bypassed limb and creation of a gastrojejunal anastomosis (GJA) using gastrojejunal lumen-apposing metal stents (GJ-LAMS) at Week 0, placement of a duodenal exclusion device (DED) at Week 2, and randomization to DJB or SG surgery at Week 8 with subsequent 4-week follow-up. At Week 12, the pigs were sacrificed and necropsy was performed. RESULTS: Endoscopic procedures were technically successful. One pig did not receive a DED due to early GJ-LAMS migration leading to premature closure of the GJA. At Week 8, all 4 pigs were doing well, and the remaining 3 GJ-LAMS and 3 DEDs were uneventfully endoscopically removed. Two one-anastomosis DJB were performed, and 2 SG were performed, closing in one case the site of the previous GJA. The surgical procedures were technically feasible and uneventful during follow-up. Necropsy assessments showed no local or peritoneal inflammation or abscess and no leakage or fistula. CONCLUSION: An endoscopic bariatric bypass can be transitioned to a one-anastomosis duodenal-jejunal bypass or sleeve gastrectomy, without complications.

First fully endoscopic metabolic procedure with NOTES gastrojejunostomy, controlled bypass length and duodenal exclusion: a 9-month porcine study.

We conducted a pilot study of a potential endoscopic alternative to bariatric surgery. We developed a Natural Orifice Transluminal Endoscopic Surgery (NOTES) gastric bypass with controlled bypass limb length using four new devices including a dedicated lumen-apposing metal stent (GJ-LAMS) and pyloric duodenal exclusion device (DED). We evaluated procedural technical success, weight change from baseline, and adverse events in growing Landrace/Large-White pigs through 38 weeks after GJ-LAMS placement. Six pigs (age 2.5 months, mean baseline weight 26.1 ± 2.7 kg) had initial GJ-LAMS placement with controlled bypass limb length, followed by DED placement at 2 weeks. Technical success was 100%. GJ-LAMS migrated in 3 of 6, and DED migrated in 3 of 5 surviving pigs after mucosal abrasion. One pig died by Day 94. At 38 weeks, necropsy showed 100-240 cm limb length except for one at 760 cm. Weight gain was significantly lower in the pigs that underwent endoscopic bypass procedures compared to expected weight for age. This first survival study of a fully endoscopic controlled bypass length gastrojejunostomy with duodenal exclusion in a growing porcine model showed high technical success but significant adverse events. Future studies will include procedural and device optimizations and comparison to a control group.

Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity.

BACKGROUND AND AIMS: Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience. METHODS: Fourteen "expert" (>2000 lifetime ERCPs) and 5 "less-expert" endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events. RESULTS: Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P = .131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P = .999), median ERCP completion time (25.0 vs 28.5 minutes, P = .130), mean cannulation attempts (2.8 vs 2.8, P = .954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P = .840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P < .001). Serious adverse events were reported in 13 patients (6.5%). CONCLUSIONS: In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.).

Safety and efficacy of lumen-apposing metal stents versus plastic stents to treat walled-off pancreatic necrosis: systematic review and meta-analysis.

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.

Novel single-use duodenoscope compared with 3 models of reusable duodenoscopes for ERCP: a randomized bench-model comparison.

BACKGROUND AND AIMS: Multidrug-resistant infectious outbreaks associated with duodenoscope reuse have been documented internationally. A single-use endoscope could eliminate exogenous patient-to-patient infection associated with ERCP. METHODS: We conducted a comparative bench simulation study of a new single-use and 3 models of reusable duodenoscopes on a synthetic anatomic bench model. Four ERCP tasks were performed: guidewire locking (single-use and 1 reusable duodenoscope only), plastic stent placement and removal, metal stent placement and removal, and basket sweeping. The study schedule included block randomization by 4 duodenoscopes, 4 tasks, and 2 anatomic model ERCP stations. Ability to complete tasks, task completion times, and subjective ratings of overall performance, navigation/pushability, tip control, and image quality on a scale of 1 (worst) to 10 (best) were compared among duodenoscopes. RESULTS: All 4 ERCP tasks (total 14 subtasks) were completed by 6 expert endoscopists using all 4 duodenoscopes, with similar task completion times (median, 1.5-8.0 minutes per task) and overall performance ratings by task (median, 8.0-10.0). Navigation/pushability ratings were lower for the single-use duodenoscope than for the 3 reusable duodenoscopes (median, 8.0, 10.0, 9.0, and 9.0, respectively; P < .01). Tip control ratings were similar among all the duodenoscopes (median, 9.0-10.0; P = .77). Image quality ratings were lower for 1 reusable duodenoscope compared with the single-use and other 2 reusable duodenoscopes (median, 8.0, 9.0, 9.0, and 9.0, respectively; P < .01). CONCLUSIONS: A new single-use duodenoscope was used to simulate 4 ERCP tasks in an anatomic model, with performance ratings and completion times comparable with 3 models of reusable duodenoscopes.

Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography.

BACKGROUND & AIMS: Disposable, single-use duodenoscopes might reduce outbreaks of infections associated with endoscope reuse. We tested the feasibility, preliminary safety, and performance of a new single-use duodenoscope in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). METHODS: We conducted a case-series study of the outcomes of ERCP with a single-use duodenoscope from April through May 2019 at 6 academic medical centers. We screened consecutive patients (18 years and older) without alterations in pancreaticobiliary anatomy and enrolled 73 patients into the study. Seven expert endoscopists performed roll-in maneuvers (duodenoscope navigation and visualization of duodenal papilla only) in 13 patients and then ERCPs in the 60 other patients. Outcomes analyzed included completion of ERCP for the intended clinical indication, crossover from a single-use duodenoscope to a reusable duodenoscope, endoscopist performance ratings of the device, and serious adverse events (assessed at 72 hours and 7 days). RESULTS: Thirteen (100%) roll-in maneuver cases were completed using the single-use duodenoscope. ERCPs were of American Society for Gastrointestinal Endoscopy procedural complexity grade 1 (least complex; 7 patients [11.7%]), grade 2 (26 patients [43.3%]), grade 3 (26 patients [43.3%]), and grade 4 (most complex; 1 patient [1.7%]). Fifty-eight ERCPs (96.7%) were completed using the single-use duodenoscope only and 2 ERCPs (3.3%) were completed using the single-use duodenoscope followed by crossover to a reusable duodenoscope. Median overall satisfaction was 9 out of 10. Three patients developed post-ERCP pancreatitis, 1 patient had post-sphincterotomy bleeding, and 1 patient had worsening of a preexisting infection and required rehospitalization. CONCLUSIONS: In a case-series study, we found that expert endoscopists can complete ERCPs of a wide range of complexity using a single-use duodenoscope for nearly all cases. This alternative might decrease ERCP-related risk of infection. Clinicaltrials.gov no: NCT03701958.

Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos).

BACKGROUND: The feasibility of single-operator cholangioscopy (SOC) for biliary diagnostic and therapeutic procedures was previously reported. OBJECTIVE: To confirm the utility of SOC in more widespread clinical use. DESIGN: Prospective clinical cohort study. SETTING: Fifteen endoscopy referral centers in the United States and Europe. PATIENTS: Two hundred ninety-seven patients requiring evaluation of bile duct disease or biliary stone therapy. INTERVENTIONS: SOC examination and, as indicated, SOC-directed stone therapy or forceps biopsy. MAIN OUTCOME MEASUREMENTS: Procedural success defined as ability to (1) visualize target lesions and, if indicated, collect biopsy specimens adequate for histological evaluation or (2) visualize biliary stones and initiate fragmentation and removal. RESULTS: The overall procedure success rate was 89% (95% CI, 84%-92%). Adequate tissue for histological examination was secured in 88% of 140 patients who underwent biopsy. Overall sensitivity in diagnosing malignancy was 78% for SOC visual impression and 49% for SOC-directed biopsy. Sensitivity was higher (84% and 66%, respectively) for intrinsic bile duct malignancies. Diagnostic SOC procedures altered clinical management in 64% of patients. Procedure success was achieved in 92% of 66 patients with stones and complete stone clearance during the study SOC session in 71%. The incidence of serious procedure-related adverse events was 7.5% for diagnostic SOC and 6.1% for SOC-directed stone therapy. LIMITATIONS: The study was observational in design with no control group. CONCLUSIONS: Evaluation of bile duct disease and biliary stone therapy can be safely performed with a high success rate by using the SOC system.