Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreaticobiilary Diseases
- Sponsor
- Air Force Military Medical University, China
- Enrollment
- 180
- Locations
- 5
- Primary Endpoint
- Migration rate of FCSEMS
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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. Compared with uncovered SEMS, FCSEMS can be removed several months later and has the advantage of longer patency. Proximal or distal migration is one of major disadvantages of FCSEMS. The migration rate ranged from 7.0%-33% in previous reports.
We hypothesized that the fixation of the distal end of FCSEMS by a metal clip could decrease the migration rate and migration-related cholangitis.
Investigators
Yanglin Pan
Associated professor
Air Force Military Medical University, China
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Migration rate of FCSEMS
Time Frame: 6 months
The proportion of patients who had stent migration after placing FCSEMS, which was defined as radiological or endoscopic evidence of distal or proximal migration within 6 months after placing FCSEMS.
Secondary Outcomes
- Complications related to stent removal(6 months)
- Proximal migration rate(6 months)
- Distal migration rate(6 months)
- Rate of cholangitis after FCSEMS placement(6 months)