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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-21

Study Completion Date

2022-11-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreaticobiilary Diseases Endoscopic Retrograde Cholangiopancreatography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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FCSEMS+Clip

After successful cannulation, a 10mm FCSEMS with the length of 6cm or 8cm were inserted into CBD. One to two centimeters of distal end of FCSEMS was left outside of the papilla and the stent was released. Then a metal clip was used to fix the distal end of FCSEMS with the duodenal mucosa adjacent to papilla.

Group Type EXPERIMENTAL

FCSEMS plus Clip

Intervention Type DEVICE

After successful cannulation, a 10mm FCSEMS with the length of 6cm or 8cm were inserted into CBD. Then a metal clip was used to fix the distal end of FCSEMS with the duodenal mucosa adjacent to papilla.

FCSEMS

FCSEMS was released as the same as mentioned above. No fixating method was used.

Group Type SHAM_COMPARATOR

FCSEMS

Intervention Type DEVICE

FCSEMS was released as the same as mentioned above. No fixating method was used.

Interventions

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FCSEMS plus Clip

After successful cannulation, a 10mm FCSEMS with the length of 6cm or 8cm were inserted into CBD. Then a metal clip was used to fix the distal end of FCSEMS with the duodenal mucosa adjacent to papilla.

Intervention Type DEVICE

FCSEMS

FCSEMS was released as the same as mentioned above. No fixating method was used.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age 18-80
2. 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

1. Expected life span ≤6 months
2. Considering tumor resection within 6 months
3. Failed CBD cannulation
4. Hilar stricture (Bismuth II, III and IV)
5. CBD dilating by a balloon catheter with diameter≥8mm
6. Inserting the whole FCSEMS into CBD and the distal end of FCSEMS invisible in endoscopic view
7. Maximal CBD diameter ≤6mm
8. Pregnancy or lactation
9. Unable to provide informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No