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

Sponsor

Air Force Military Medical University, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT04325152

Collaborator

The Second Affiliated Hospital of Chongqing Medical University (Other), Huaihe Hospital of Henan University (Other), Xiamen Humanity Hospital (Other), The Third Affiliated Hospital of Second Military Medical University (Other)

181

Enrollment

Locations

Arms

18.9

Anticipated Duration (Months)

36.2

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreaticobiilary Diseases Endoscopic Retrograde Cholangiopancreatography	Device: FCSEMS plus Clip Device: FCSEMS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

181 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Anticipated Primary Completion Date :

Feb 28, 2021

Anticipated Study Completion Date :

Aug 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Sham Comparator: FCSEMS FCSEMS was released as the same as mentioned above. No fixating method was used.	Device: FCSEMS FCSEMS was released as the same as mentioned above. No fixating method was used.

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Sham Comparator: FCSEMS

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

Device: FCSEMS

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

Outcome Measures

Primary Outcome Measures

Migration rate of FCSEMS [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 Outcome Measures

Distal migration rate [6 months]
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.
Proximal migration rate [6 months]
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.
Rate of cholangitis after FCSEMS placement [6 months]
The proportion of patients who had the complication of cholangitis during follow up, due to stent migration, tumor/tissue ingrowth or food impaction.
Complications related to stent removal [6 months]
Including failed extraction of the stent, bleeding or cholangitis which needed further management after stent removal.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	The Third Affiliated Hospital of Second Military Medical University	Shanghai		China	200433

Sponsors and Collaborators

Air Force Military Medical University, China
The Second Affiliated Hospital of Chongqing Medical University
Huaihe Hospital of Henan University
Xiamen Humanity Hospital
The Third Affiliated Hospital of Second Military Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yanglin Pan, Associated professor, Air Force Military Medical University, China

ClinicalTrials.gov Identifier:

NCT04325152

Other Study ID Numbers:

KY20200113-2

First Posted:

Mar 27, 2020

Last Update Posted:

Mar 27, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yanglin Pan, Associated professor, Air Force Military Medical University, China

ERCP

Fully Covered Self-expandable Metal Stent

Study Results

No Results Posted as of Mar 27, 2020