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

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325152
• Other study ID #: KY20200113-2
• Status: Completed
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: November 19, 2022

Study information

• Verified date: January 2024
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 19, 2022
• Est. primary completion date: November 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Retrograde Cholangiopancreatography
• Pancreaticobiilary Diseases

Intervention

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

Locations

Country	Name	City	State
China	Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University	Chongqing
China	Huaihe Hospital of Henan University	Kaifeng	Henan
China	The Third Affiliated Hospital of Second Military Medical University	Shanghai
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi
China	Xiamen Humanity Hospital	Xiamen	Fujian

Sponsors (5)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Complications related to stent removal	Including failed extraction of the stent, bleeding or cholangitis which needed further management after stent removal.	6 months