Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos).

BACKGROUND

Tubular plastic and metal stents have inherent shortcomings when used for transenteric drainage of fluid collections.

OBJECTIVE

To evaluate a novel lumen-apposing, self-expandable metal stent for EUS-guided drainage of pancreatic pseudocysts and the gallbladder.

DESIGN

Retrospective case series.

SETTING

Tertiary-care academic medical center.

PATIENTS: This study involved 15 patients (median age 54 years) with symptomatic pancreatic pseudocysts who underwent 12 transgastric and 3 transduodenal pseudocyst drainage procedures. Five patients (median age 69.5 years) with acute cholecystitis underwent 4 cholecystoduodenostomies and 1 cholecystogastostomy.

INTERVENTION: Stent deployment under EUS guidance, passage of an endoscope through the stent lumen for pseudocystoscopy or cholecystoscopy, transenteric endoscopy-guided interventions including biopsy, necrosectomy, and stone removal.

MAIN OUTCOME MEASUREMENTS: Technical and clinical success.

RESULTS

All stents were successfully deployed without complication, with a median time to removal of 35 days. All pseudocysts resolved after a single drainage procedure. One stent migrated into the stomach, and the remaining 14 were found to be patent at the time of removal. There was no pseudocyst recurrence during the 11.4-month median follow-up period. One gallbladder stent remains indwelling and fully patent at 12 months. Resolution of acute cholecystitis was observed immediately after stent implantation. No recurrence of symptoms was observed during a median follow-up period of 9 months.

LIMITATIONS: Retrospective study, small sample size, lack of control patients.

CONCLUSION

Transenteric drainage of pancreatic pseudocysts and the gallbladder by using a novel, lumen-apposing, metal stent was accomplished with high technical and clinical success in this pilot observational study. Further studies are warranted.