Acute Cholecystitis Clinical Trial
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
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
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.
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