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

NCT ID: NCT05729867

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-27
• Study Completion Date: 2025-04-26

Brief Summary

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.

Detailed 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.

Conditions

Malignant Biliary Obstruction; Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fully covered self-expanable metal stent with HCC

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.

Group Type: EXPERIMENTAL

Endoscpic biliary drainage using fully covered metal stent

Intervention Type: PROCEDURE

After selective cannulation of the bile duct, cholangiography is obtained using contrast agent.

A guide wire is passed through the stricture, and then fully-covered metal stent is inserted under fluoroscopy guidance during ERCP.

Interventions

Endoscpic biliary drainage using fully covered metal stent

After selective cannulation of the bile duct, cholangiography is obtained using contrast agent.

A guide wire is passed through the stricture, and then fully-covered metal stent is inserted under fluoroscopy guidance during ERCP.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Hyub Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Hyub Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sang Hyub Lee, MD, PhD

Role: CONTACT

gidoctor@snu.ac.kr

82-2072-2228

Facility Contacts

Sang Hyub Lee, MD. PhD.

Role: primary

gidoctor@snu.ac.kr

+82-2-2072-4892

Other Identifiers

H-2004-175-1119

Identifier Type: -

Identifier Source: org_study_id