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Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC

Recruiting
19 years of age
Both
Phase N/A

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Overview

The effectiveness and safety of fully covered metal stent in malignant biliary obstruction caused by HCC are still unknown. These would be clarified in this prospective cohort study.

Description

In this study, endoscopic biliary drainage was performed using fully covered self-expancdable metal stent for malignant biliary obstruction caused by HCC. Main outcome is efficacy and safety of this procedure including clinical success rate, technical success rate, stent patency, stent dysfunction, and any adverse events during the follow-up period.

Eligibility

Inclusion Criteria:

  • Adults aged 19 years or older, those who consented to the clinical research participation and signed a written consent form
  • Obstructive jaundice caused by unresectable hepatocellular carcinoma

Exclusion Criteria:

  • Patients who have previously undergone surgical biliary drainage
  • Patients who need to remain percutaneous transhepatic biliary drainage
  • Patients whose life expectancy is less than 3 months (BCLC stage D without a treatment plan for hepatocellular carcinoma)
  • Patients who cannot undergo endoscopic procedure according to the judgment of the researcher

Study details

Malignant Biliary Obstruction, Hepatocellular Carcinoma

NCT05729867

Seoul National University Hospital

25 January 2024

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