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

Not Applicable

Recruiting

• Conditions: Malignant Biliary Obstruction; Hepatocellular Carcinoma
• Interventions: Procedure: Endoscpic biliary drainage using fully covered metal stent

• Registration Number: NCT05729867
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2020-04-27
• Status Verified: 2023-02
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Last Update Submitted: 2023-02-14
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-16
• Primary Completion: 2024-04-26
• Study Completion: 2025-04-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fully covered self-expanable metal stent with HCC	Endoscpic biliary drainage using fully covered metal stent	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.

Primary Outcome Measures

Name	Time	Method
Clinical success rate	1 month	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.
Technical success rate	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Stent patency duration	1 year	Stent patency duration is defined as number of days between immediately after procedure and occurrence of stent dysfunction.
Stent migration rate	1 year	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.
Stent dysfunction rate	1 year	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of