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

Seoul National University

Status: Enrolling

Conditions: Hepatocellular Carcinoma; Malignant Biliary Obstruction

Treatments: Procedure: Endoscpic biliary drainage using fully covered metal stent

Study type: Interventional

Funder types: Other

Identifiers

NCT05729867

H-2004-175-1119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

fully covered self-expanable metal stent with HCC

Experimental group

Description:

This prospective cohort is comprised of patients with malignant biliary obstruction caused by hepatocellular carcinoma who were treated with endoscopic biliary drainage using fully covered self expandable metal stent.

Treatment:

Procedure: Endoscpic biliary drainage using fully covered metal stent