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

Non Recruiting
19 years of age
Both
Phase N/A

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Overview

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

Description

This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.

Eligibility

Inclusion Criteria:

  • Adults with 19 years of age or older
  • Those who voluntarily consented to the trial and signed a written consent
  • Inoperable malignant biliary obstruction

Exclusion Criteria:

  • Previous surgical biliary drainage
  • Patients continuosly requiring percutaneous transhepatic biliary drainage
  • History of biliary drainage with metal stent
  • Biliary obstruction located in hilum or intrahepatic duct
  • Patients with life expectancy of 3 months or less
  • On pregnancy
  • Unable to underwent endoscopic procedures

Study details

Malignant Biliary Obstruction

NCT05220475

Seoul National University Hospital

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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