Status:
COMPLETED
Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP
Lead Sponsor:
Air Force Military Medical University, China
Collaborating Sponsors:
The Second Affiliated Hospital of Chongqing Medical University
Huaihe Hospital of Henan University
Conditions:
Pancreaticobiilary Diseases
Endoscopic Retrograde Cholangiopancreatography
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Fully covered self-expandable metal stent (FCSEMS) has been widely used in ERCP patients with malignant or benign biliary stricture, difficult CBDS, post-EST bleeding, bile leak or perforation. Compar...
Eligibility Criteria
Inclusion
- Age 18-80
- Patients with ERCP indications who were suitable for FCSEMS placement, such as benign or malignant biliary stricture, difficult CBDS, biliary or papillary bleeding, bile leak or perforation etc.
Exclusion
- Expected life span ≤6 months
- Considering tumor resection within 6 months
- Failed CBD cannulation
- Hilar stricture (Bismuth II, III and IV)
- CBD dilating by a balloon catheter with diameter≥8mm
- Inserting the whole FCSEMS into CBD and the distal end of FCSEMS invisible in endoscopic view
- Maximal CBD diameter ≤6mm
- Pregnancy or lactation
- Unable to provide informed consent
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2022
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04325152
Start Date
October 21 2019
End Date
November 19 2022
Last Update
January 17 2024
Active Locations (5)
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1
Xiamen Humanity Hospital
Xiamen, Fujian, China, 361001
2
Huaihe Hospital of Henan University
Kaifeng, Henan, China, 475000
3
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
4
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Chongqing, China, 400010