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

Seoul National University Hospital50 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Biliary Obstruction Hepatocellular Carcinoma

Interventions

Endoscpic biliary drainage using fully covered metal stentPROCEDURE

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Clinical success rate

Clinical success rate is defined as a reduction of total bilirubin level above 50% or total bilirubin level less than 2 mg/dL within 1 month after the procedure. Clinical success rate of all procedures will be measured.

Time frame: 1 month

Technical success rate

Technical success is defined as whether the stent is properly inserted into the stricture site and the bile or contrast agent is drained. Technical success rate of all procedures will be measured.

Time frame: 1 day

Secondary Outcomes

Stent patency duration

Stent patency duration is defined as number of days between immediately after procedure and occurrence of stent dysfunction.

Time frame: 1 year

Stent migration rate

Stent migration is divided in two types. Proximal dislocation is defined as the movement of the stent into the bile duct at the site of obstruction, and distal dislocation is defined as the distal displacement of the stent from the stenotic site (including cases where the stent is not observed due to self-removal). The rate of stent migration including both proximal and distal dislocation will be measured.

Time frame: 1 year

Stent dysfunction rate

The stent dysfunction includes stent migration, occlusion, jaundice after stent insertion (increased more than 2-fold based on the lowest total bilirubin level), situations requiring endoscopy or radiologic intervention. The stent dysfunction rate of all patients will be measured.

Time frame: 1 year

Central Contacts

Sang Hyub Lee, MD, PhD

CONTACT

82-2072-2228 gidoctor@snu.ac.kr

Data from ClinicalTrials.gov

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