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

Study Overview
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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.

Official Title
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Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP: a Randomized Controlled Trial

Conditions
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Pancreaticobiilary Diseases, Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
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* Device: FCSEMS plus Clip
* Device: FCSEMS


Participation Criteria
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Eligibility Criteria
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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 Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FCSEMS+Clip<br>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. | Device: FCSEMS plus Clip<br>* 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.<br>|
| Sham Comparator: FCSEMS<br>FCSEMS was released as the same as mentioned above. No fixating method was used. | Device: FCSEMS<br>* FCSEMS was released as the same as mentioned above. No fixating method was used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migration rate of FCSEMS | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distal migration rate | The proportion of patients who had distal migration of FCSEMS, which was defined as radiological or endoscopic evidence of fully or partially distal migration of the stent out of CBD during follow up. Fully distal migration: The whole stent was out of CBD or disappeared in fluoroscopy. Partially distal migration: More than half length of FCSEMS was visible in endoscopic view. | 6 months | 
| Proximal migration rate | The proportion of patients who had proximal migration of FCSEMS, which was defined as radiological or endoscopic evidence of fully or partially proximal migration of the stent into CBD during follow up. Fully proximal migration: The whole stent was in CBD and the distal end was not visible. Partially proximal migration: Less than 0.5cm of distal end of FCSEMS was visible in endoscopic view. | 6 months | 
| Rate of cholangitis after FCSEMS placement | The proportion of patients who had the complication of cholangitis during follow up, due to stent migration, tumor/tissue ingrowth or food impaction. | 6 months | 
| Complications related to stent removal | Including failed extraction of the stent, bleeding or cholangitis which needed further management after stent removal. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, Fully Covered Self-expandable Metal Stent