Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-05 @ 5:31 PM
Study NCT ID:
NCT03002051
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2016-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: