Clinical trial NCT04325152: Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP
Official title: Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreaticobiilary Diseases
Endoscopic Retrograde Cholangiopancreatography
Keywords: ERCP
Fully Covered Self-expandable Metal Stent
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Chongqing Medical University
name: Huaihe Hospital of Henan University
name: Xiamen Humanity Hospital
name: The Third Affiliated Hospital of Second Military Medical University
First posted: 2020-03-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Migration rate of FCSEMS
timeFrame: 6 months
Secondary outcomes:
measure: Distal migration rate
timeFrame: 6 months
measure: Proximal migration rate
timeFrame: 6 months
measure: Rate of cholangitis after FCSEMS placement
timeFrame: 6 months
measure: Complications related to stent removal
timeFrame: 6 months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Humanity Hospital
state: Fujian
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
city: Chongqing
country: China
facility: Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
city: Shanghai
country: China
facility: The Third Affiliated Hospital of Second Military Medical University
Study officials:
References: