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

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

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.

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatography; Pancreaticobiilary Diseases
• Intervention / Treatment: Device: FCSEMS plus Clip; Device: FCSEMS

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanglin Pan, M.D.; Phone Number: +8613201851680; Email: yanglinpan@hotmail.com

Study Locations

• China
  • Chongqing, China, 400010
    • Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
  • Shanghai, China, 200433
    • The Third Affiliated Hospital of Second Military Medical University
  • Fujian
    • Xiamen, Fujian, China, 361001
      • Xiamen Humanity Hospital
  • Henan
    • Kaifeng, Henan, China, 475000
      • Huaihe Hospital of Henan University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): November 19, 2022
• Study Completion (Actual): November 19, 2022

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ERCP; Fully Covered Self-expandable Metal Stent
• Other Study ID Numbers: KY20200113-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No