CompletedNot Applicable

Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP

China180 participantsStarted 2019-10-21

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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 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

What they're measuring

Migration rate of FCSEMS

Timeframe: 6 months

Trial details

NCT IDNCT04325152

SponsorAir Force Military Medical University, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-19

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