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A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent

NCT05220475 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-02-02

No results posted yet for this study

Summary

Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction

Conditions

  • Malignant Biliary Obstruction

Interventions

DEVICE

fully covered self-expandable metal stent with an anchoring external plastic stent

Extrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent

DEVICE

uncovered self-expandable metal stent

Extrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent

Sponsors & Collaborators

  • 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
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2023-10-24
Completion
2024-10-24

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 NCT05220475 on ClinicalTrials.gov