NCT03439020

Brief Summary

The aim of this study is to demonstrate that the group with an additional plastic stent to anchor the fully covered self expandable metal stent (FCSEMS) in patients with malignant biliary stricture has less stent migration than the group with FCSEMS only. The primary outcome is stent migration for 6 months. The secondary outcomes are stent related adverse events, stent patency, and overall survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 1, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

February 26, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

1.7 years

First QC Date

February 1, 2018

Last Update Submit

November 20, 2019

Conditions

Malignant Biliary Stricture

Outcome Measures

Primary Outcomes (1)

  • Stent migration rate

    Stent migration is classified as proximal or distal migration. Proximal stent migration is defined as any migration of the FCSEMS(Fully covered self expandable metal stent) into the bile duct, preventing its easy removal. Distal stent migration is defined in three ways. The first is when the stent is completely distally migrated without being lodged into the duodenum. The second is when the stent is lodged in the distal bile duct below the stricture. The third case is when the stent is migrated to the distal portion of the stricture and is lodged in the duodenum opposite the papilla

    6 months after randomization

Secondary Outcomes (3)

  • Stent-related adverse events

    6 months after randomization

  • Duration of stent patency

    6 months after randomization

  • Overall survival

    6 months after randomization

Study Arms (2)

FCSEMS + Plastic

EXPERIMENTAL

Insert a fully covered self expandable metal stent (FCSEMS) for malignant biliary stricture and insert an additional plastic stent to anchor the metal stent. (Plastic stent anchoring)

Procedure: Plastic stent anchoringProcedure: FCSEMS

FCSEMS

ACTIVE COMPARATOR

Insert only a fully covered self expandable metal stent (FCSEMS) without a plastic stent for malignant biliary stricture.

Procedure: FCSEMS

Interventions

Plastic stent anchoringPROCEDURE

Insert an additional plastic stent to anchor the fully covered self expandable metal stent.

FCSEMS + Plastic
FCSEMSPROCEDURE

Insert a fully covered self expandable metal stent (FCSEMS) for malignant biliary stricture

FCSEMSFCSEMS + Plastic

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Malignant biliary stricture requiring biliary drainage through endoscopic procedure

You may not qualify if:

  • Previous history of metal stent placement for malignant biliary stricture
  • Hilar cholangiocarcinoma
  • Malignant biliary stricture of intrahepatic duct
  • A recurrence after surgery due to malignant biliary stricture
  • Life expectancy less than 3 months
  • Pregnancy
  • If endoscopy is not possible based on the judgement of the researcher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • Paik WH, Woo SM, Chun JW, Song BJ, Lee WJ, Ahn DW, Lee YS, Choi YH, Ryu JK, Kim YT, Lee SH. Efficacy of an internal anchoring plastic stent to prevent migration of a fully covered metal stent in malignant distal biliary strictures: a randomized controlled study. Endoscopy. 2021 Jun;53(6):578-585. doi: 10.1055/a-1256-0571. Epub 2020 Oct 8.

    PMID: 32886935DERIVED

Study Officials

  • Sang Hyub Lee, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 20, 2018

Study Start

February 26, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations

KR(1)