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Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03002051
Study type Interventional
Source Chinese University of Hong Kong
Status Completed
Phase N/A
Start date October 2016
Completion date May 2019

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