Clinical trialNACompleted
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent for the Management of Pancreato-biliary Diseases: a Multi-national, Multicenter Prospective Study
- Outcome
- Finished, no results posted
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- October 2016
- Expected end
- May 2019
- Enrollment
- 114 participants
- Sites
- 1
- Primary outcomes
- Clinical success for pancreatic fluid collections; Clinical success for acute cholecystitis; Clinical success for obstructive jaundice
- Sponsor
- Other
- Results posted
- No
- Last update
- 13 December 2019
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Source text
Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.