Spots Global Cancer Trial Database for EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent

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Trial Identification

Brief Title: EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent

Official Title: EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent for the Management of Pancreato-biliary Diseases: a Multi-national, Multicenter Prospective Study

Study ID: NCT03002051

Conditions

Pancreatic Pseudocyst

Pancreatic Necrosis

Biliary Obstruction

Acute Cholecystitis

Interventions

EUS-guided drainage

Study Description

Brief Summary: To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided transenteric drainage of PFC or of biliary tree including GB

Detailed Description: Patients with the following conditions would be recruited for drainage under EUS guidance with the new lumen apposing FCSEMS * Symptomatic or infected pancreatic pseudocyst or walled-off necrosis (WON) (SPAXUS 16 or 10 mm) * Acute cholecystitis by inoperable malignant diseases (SPAXUS 10 mm) * Acute cholecystitis by benign conditions with high-risk for operation (SPAXUS 10 mm) * Long-term cholecystostomy at high-risk for operation (SPAXUS 10 mm) * Symptomatic malignant obstruction of the distal CBD with unsuccessful transpapillary approach (the diameter of the CBD \> 10 mm) (SPAXUS 8 or 10 mm) Outcome paramaters include technical and clinical success, adverse events.