Use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: Long term outcomes of a prospective international trial.

BACKGROUND: Long-term placement of lumen apposing metal stents (LAMS) with high lumen apposing force may result in adverse events. The aim of the current study was to assess the long-term efficacy and safety of a self-approximating LAMS with lower lumen apposing force for endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) and -gallbladder drainage (EUS-GBD). METHODS: Five Asian institutions participated in this study. Consecutive patients suffering from obstructive jaundice with failed ERCP or acute cholecystitis that were at high risk for cholecystectomy were recruited. We evaluated the technical and clinical success rates, adverse events rates, types of interventions through the stent and the patency profile. RESULTS: From June 2017 to Oct 2018, a total of 53 patients received EUS-CDS (26) and EUS-GBD (27). The technical and clinical success rates were similar between the two groups (88.5% vs 88.9%, P = 1 and 88.5% vs 88.9%, P = 1 respectively). The differences in 30-day mortality rates [2 (7.7%) vs 2 (7.7%), P = 1] and adverse events [3 (11.5%) vs 3 (11.5%), P = 1] did not reach significance. Regarding long-term outcomes, two patients in each group suffered from adverse events (P = 1). One patient in the EUS-GBD group who was on direct oral anticoagulant suffered from stent induced bleeding. CONCLUSION: The self-approximating LAMS with lower lumen apposing force was effective and safe with a low risk of buried stent syndrome and bleeding in the longer term. The ClinicalTrials.gov Identifier was NCT03002051.

Prospective multicenter international study on the outcomes of a newly developed self-approximating lumen-apposing metallic stent for drainage of pancreatic fluid collections and endoscopic necrosectomy.

BACKGROUND: A novel self-approximating lumen-apposing metallic stent (LAMS; Niti-S Spaxus, Taewoong Medical, Gyeonggi-do, Korea) has recently become available. The aim of the present study was to evaluate the outcomes for drainage of pancreatic fluid collections (PFC). METHODS: This was a prospective international multicentered study conducted in six high-volume institutions across Asia. Consecutive patients suffering from pancreatic pseudocyst or walled-off pancreatic necrosis (WOPN) requiring endoscopic ultrasonography-guided drainage were recruited. Outcomes included technical and clinical success, adverse events, procedural events, interventions through the stent and recurrence rates. RESULTS: Between August 2016 and November 2017, 59 patients were recruited to this study. Thirty-nine patients (66.1%) had WOPN and mean (SD) size of PFC was 11.5 (5.1) cm. Technical and clinical success rates were 100%. Mean (SD) procedural time was 35.0 (17.2) minutes. Sixteen-millimeter stents were used in 66.1% of the patients. Fifty-four sessions of necrosectomy were carried out with the stent in situ in 17 patients. Stent-related adverse event (AE) rate was 6.8%. Three patients (5.1%) suffered from bleeding after stenting and one required angiographic embolization. Two patients (3.4%) suffered from recurrence during a mean (SD) follow-up time of 325.6 (355.5) days. There were no differences in outcomes between those with pseudocysts or WOPN except for the duration of hospital stay (P = 0.012). CONCLUSION: Use of a self-approximating LAMS for drainage of PFC was safe and effective. Endoscopic necrosectomy could be carried out through the stent with ease. The device was associated with a low rate of stent-related AE.