NCT04325152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2022

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

3.1 years

First QC Date

March 26, 2020

Last Update Submit

January 16, 2024

Conditions

Pancreaticobiilary DiseasesEndoscopic Retrograde Cholangiopancreatography

Keywords

ERCPFully Covered Self-expandable Metal Stent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Distal migration rate

    6 months

  • Proximal migration rate

    6 months

  • Rate of cholangitis after FCSEMS placement

    6 months

  • Complications related to stent removal

    6 months

Study Arms (2)

FCSEMS+Clip

EXPERIMENTAL

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

FCSEMS

SHAM COMPARATOR

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

Device: FCSEMS

Interventions

FCSEMS plus ClipDEVICE

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+Clip
FCSEMSDEVICE

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

FCSEMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80
  • 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.

You may not qualify if:

  • Expected life span ≤6 months
  • Considering tumor resection within 6 months
  • Failed CBD cannulation
  • Hilar stricture (Bismuth II, III and IV)
  • CBD dilating by a balloon catheter with diameter≥8mm
  • Inserting the whole FCSEMS into CBD and the distal end of FCSEMS invisible in endoscopic view
  • Maximal CBD diameter ≤6mm
  • Pregnancy or lactation
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Xiamen Humanity Hospital

Xiamen, Fujian, 361001, China

Location

Huaihe Hospital of Henan University

Kaifeng, Henan, 475000, China

Location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University

Chongqing, 400010, China

Location

The Third Affiliated Hospital of Second Military Medical University

Shanghai, 200433, China

Location

Related Publications (1)

  • Wang X, Shi X, Luo H, Ren G, Wang X, Zhao J, Li H, Ning B, Yi H, Zhong L, Zhang R, Ni Z, Liang S, Xia M, Hu B, Pan Y, Fan D. Effects of Clip Anchoring on Preventing Migration of Fully Covered Self-Expandable Metal Stent in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: A Multicenter, Randomized Controlled Study. Am J Gastroenterol. 2024 Oct 1;119(10):2028-2035. doi: 10.14309/ajg.0000000000002813. Epub 2024 Apr 15.

    PMID: 38619136DERIVED

MeSH Terms

Interventions

Surgical Instruments

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 27, 2020

Study Start

October 21, 2019

Primary Completion

November 19, 2022

Study Completion

November 19, 2022

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)