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

Air Force Military Medical University, China180 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

180

Conditions

Pancreaticobiilary Diseases Endoscopic Retrograde Cholangiopancreatography

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (5)

Xiamen Humanity Hospital

Xiamen, Fujian, China

Huaihe Hospital of Henan University

Kaifeng, Henan, China

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

The Third Affiliated Hospital of Second Military Medical University

Shanghai, China

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Complications related to stent removal

Including failed extraction of the stent, bleeding or cholangitis which needed further management after stent removal.

Time frame: 6 months