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

Not Applicable

Completed

• Conditions: Pancreaticobiilary Diseases; Endoscopic Retrograde Cholangiopancreatography
• Interventions: Device: FCSEMS; Device: FCSEMS plus Clip

• Registration Number: NCT04325152
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-21
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Primary Completion: 2022-11-19
• Study Completion: 2022-11-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FCSEMS	FCSEMS	FCSEMS was released as the same as mentioned above. No fixating method was used.
FCSEMS+Clip	FCSEMS plus 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Complications related to stent removal	6 months	Including failed extraction of the stent, bleeding or cholangitis which needed further management after stent removal.
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.
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.
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.

Trial Locations

Locations (5)

Xiamen Humanity Hospital; 🇨🇳 Xiamen, Fujian, China

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China

Huaihe Hospital of Henan University; 🇨🇳 Kaifeng, Henan, China

Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China

The Third Affiliated Hospital of Second Military Medical University; 🇨🇳 Shanghai, China