ENTERO-ENTERIC LUMEN APPOSING METAL STENTS (LAMS) FOR BILIARY ACCESS IN PATIENTS WITH ALTERED ANATOMY: A MULTICENTER COLLABORATIVE STUDY

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.

Background:
The applications of lumen apposing metal stents (LAMS) have considerably expanded since its introduction. One such application is in patients with altered surgical anatomy other than Roux-en-Y gastric bypass with biliary pathology where anatomical reconfiguration has precluded access using a pediatric colonoscope or double balloon enteroscope. In these cases, entero-enteric LAMS (E-E LAMS) between adjacent limbs of small bowel allows direct access to the afferent limb and bile duct for endoscopic therapy. There is minimal literature on this technique for biliary access, and the success of E-E LAMS is not known. We aim to describe the safety and efficacy of E-E LAMS.

Methods:
This was a multicenter retrospective cohort study of patients who underwent E-E LAMS for the purpose of biliary intervention at 3 US centers. The primary outcome measured was technical success. Secondary outcomes measured included clinical success, defined as ability to provide efficient biliary intervention. Indications for E-E LAMS and adverse events associated with this procedure were also captured. Descriptive statistics were used to analyze the data.

Results:
17 patients underwent E-E LAMS for biliary access most often performed for biliary obstruction (47.1%) and cholangitis (45.5%) (Table 1). In 76.5% of patients, E-E LAMS was performed following failed access with deep enteroscopy or hepaticogastrostomy; for others E-E LAMS was the initial procedure. Technical and clinical success were achieved in 100% of patients. Roux-en-Y hepaticojejunostomy (RYHJ) anatomy was present in 64.7% of patients. 47.0% had malignant disease and 25% of those patients had evidence of omental metastases or ascites.

A 20 mm LAMS was used in 70.6% of patients. Access to the afferent jejunal limb was achieved either from the duodenum (47.1%) or the jejunum (52.9%). A wire-guided technique was used in 42.6%. In just over half of patients the LAMS was sutured after deployment and dilation. A single channel therapeutic scope was most frequently used to perform ERCP (76.5%). Two adverse events were noted; 1 patient had a perforation of the opposite jejunal wall that was treated with through-the-scope clips accessed through the LAMS, and one patient had minor bleeding that was managed conservatively. There was no misdeployment, stent dislodgement or migration.

Conclusions:
This is the largest study to date evaluating the safety and efficacy of E-E LAMS and demonstrates 100% technical and clinical success for biliary intervention with minimal risk of adverse events. These findings further broaden the spectrum of endoscopic options for biliary access in patients with altered anatomy and allow more advantageous endoscopes to be used for biliary interventions.