A RANDOMIZED TRIAL OF ENDOSCOPIC TRANSPAPILLARY GALLBLADDER STENTING VERSUS EUS-GUIDED TRANSMURAL GALLBLADDER DRAINAGE IN THE PATIENTS WITH ACUTE CALCULOUS CHOLECYSTITIS AND HIGH SURGICAL RISK: THE OUTCOMES AT 18 MONTHS

Introduction: It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing metal stents (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency.
Objective: The aim is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (CDS-type) for the management of distal malignant biliary obstruction.
Methods: This is a multicentre, open-label, randomised controlled trial with two parallel groups. The primary endpoint was the rate of recurrent biliary obstruction (RBO), as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin >50% within 14days), adverse events, and others.
Results: Between November-2020 and October-2022, 123 patients were screened and 84 with malignant biliary obstruction, and underwent EUS-CDS, were randomised: 44 patients in LAMS group and 40 in LAMS-DPS group. The rate of RBO (31.8 vs12.5%; OR 3.26[IC95% 1.05–10.12], p=0.04) was higher in LAMS group, and procedure time (30 vs 20-min, p=0.02) in DPS-group. Although, more biliary reinterventions (22.7 vs 12.5%, p=0.26) and longer time-to-RBO (51.5 vs 155.5days, p=0.10) were encountered in LAMS group, it was non-significant. AEs were higher in DPS-group (4.5 vs20%, p=0.04). No differences between technical (88 vs 97%) and clinical success (88 vs 92%). NCT04595058 ClinicalTrials.gov.
Conclusions: This trial confirms that CDS with LAMS is an effective technique. The technical strategy of placing a pigtail within the LAMS is associated with a lower risk of RBO, but longer procedure time and related-AEs.

Reference: Garcia-Sumalla A, Loras C, Sanchiz V, et al. Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction-BAMPI TRIAL: an open-label, randomized controlled trial protocol. Trials. 2022; 23: 181.

Background and aims: Endoscopic transpapillary gallbladder stenting (ETGS) and endoscopic ultrasound-guided transmural stenting (EUGS) has been proposed as an alternative treatment in patients with acute cholecystitis (AC) who are not surgical candidate. We compared the outcomes of ETGS and EUGS in patients with AC at high surgical risk during an18-month follow-up.
Methods: We enrolled patients with AC at high surgical risk (Charlson Comorbidity Index ≥6) between 2021-2022. Patients were randomized to group A (received ETGS) and group B (received EUGS). A 7-Fr, 15-cm double-pigtail plastic stent (DPS) was used for ETGS. A 15- or 16-mm lumen-apposing metal stent (LAMS) or a 10x60 mm fully covered self-expandable metal stent with a 7-Fr/5-cm DPS for metallic stent anchoring (FCSEMS-DPS) were used for EUGS.
Result: We randomized 42 patients into group A (n=22) and group B (n=20). Group A had lower technical success rate (TSR) but did not reach statistical significance when compared to group B [19/22 (86.4%) vs. 20/20 (100%); p=0.09] and had similar clinical success rate (CSR) [19/19 (100%) vs. 20/20 (100%); p=1.00] (Table). Three patients did not achieve ETGS due to an acute angle of the cystic duct(n=1) and cystic duct stone obstructing a guidewire advancing into the gallbladder(n=2). The management after ETGS failure included subsequent EUGS (n=2) and EUS-guided gallbladder aspiration (n=1). Procedure-related adverse events (PAE) rates did not differ between group A and B (13.6% vs. 20%; p=0.58). In group A, 2 patients had recurrence after 9 months (at day 285 and 436) due to stent occlusion and both received ETGS stent replacement. In group B, FCSEMS-DPS migration was seen in one patient on routine plain film at 2 weeks after EUGS and this patient developed early recurrence at day 71, eventually this patient had LAMS as a replacement. At 3, 6, 12, and 18 months, the rates of recurrent AC in those who still survived were not statistically different [groups A and B: 0% (0/20) vs. 5.6% (1/18); p=0.56, 0% (0/18) vs. 7.1% (1/14); p=0.35, 5.9% (1/17) vs. 8.3% (1/12); p=0.47 and 13.3% (2/15) vs. 9.1% (1/11); p=0.64, respectively]. Death unrelated to gallstone was noted in 4 and 7 patients in group A and B, respectively (range 8-563 days after procedure). Kaplan-Meier plots demonstrated that the rates of recurrence were comparable between the two groups (p=0.61) during follow-up (median 394 days; range 8-700 days) (Figure).
Conclusion: ETGS tended to have a lower TSR compared to EUGS with comparable CSR and PAEs in the patients with AC who are not surgical candidate. During an 18-month follow-up, recurrent AC tended to be higher in ETGS group due to stent occlusion that developed at 9 months or later. For EUGS, early tubular stent migration was the only cause for recurrence, LAMS should be more preferred to prevent stent migration.