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The Efficacy of Plastic Stent Anchoring to Reduce Migration of Metal Stent

NCT03439020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-11-21

No results posted yet for this study

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.

Conditions

  • Malignant Biliary Stricture

Interventions

PROCEDURE

Plastic stent anchoring

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

PROCEDURE

FCSEMS

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

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Sang Hyub Lee, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03439020 on ClinicalTrials.gov