A newly designed fully covered metal stent for lumen apposition in EUS-guided drainage and access: a feasibility study (with videos)

Abstract

BACKGROUND: A lumen-apposing stent can be used effectively under endosonographic guidance. OBJECTIVE: To evaluate a newly designed, fully covered self-expandable metal stent with folding anchoring flanges for lumen apposition assembled on a conventional delivery system. DESIGN: Retrospective case series and animal study. SETTING: Tertiary care academic medical centers. SUBJECTS: Six pigs for animal study and 7 patients, 3 of whom underwent endoscopic drainage for acute cholecystitis (AC) and 4 for pancreatic fluid collection (PFC). INTERVENTION: Stent deployment under EUS guidance after puncturing, passage of an endoscope through the stent into the gallbladder (GB), or PFC with conventional endoscopic procedures. MAIN OUTCOME MEASUREMENTS: Technical and clinical success, adverse events, and removability. RESULTS: In the animal study, the stent was successfully inserted and deployed in the GB via a transgastric approach under EUS guidance without adverse events in all 6 pigs. Contrast injection demonstrated the absence of leakage. Cholecystoscopy with enhanced endoscopy was performed successfully in all animals after stent placement. All stents were intact and were removed successfully at 4 weeks. GB firmly adhered to the stomach with an intact cholecystogastric tract on necropsy and histopathology. The stents were successfully deployed without adverse effects in 7 patients. AC or PFC was resolved after stent placement in all patients. Endoscopic procedures were possible through the stent. Stent migration was not observed. The stent was successfully removed from the 4 patients with PFC after complete resolution. LIMITATIONS: Small sample size, retrospective study. CONCLUSIONS: Transenteric drainage and endoscopic intervention by using a novel fully covered self-expandable metal stent for lumen apposition under EUS guidance is feasible for the management of AC and PFC. Further study is warranted.