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

BackgroundA lumen-apposing stent can be used effectively under endosonographic guidance.ObjectiveTo evaluate a newly designed, fully covered self-expandable metal stent with folding anchoring flanges for lumen apposition assembled on a conventional delivery system.DesignRetrospective case series and animal study.SettingTertiary care academic medical centers.SubjectsSix pigs for animal study and 7 patients, 3 of whom underwent endoscopic drainage for acute cholecystitis (AC) and 4 for pancreatic fluid collection (PFC).InterventionStent 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 MeasurementsTechnical and clinical success, adverse events, and removability.ResultsIn 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.LimitationsSmall sample size, retrospective study.ConclusionsTransenteric 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.