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

Hepatocellular Carcinoma Clinical Trial

Official title:

Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable Hepatocellular Carcinoma: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05729867
• Other study ID #: H-2004-175-1119
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: April 26, 2025

Study information

• Verified date: February 2023
• Source: Seoul National University Hospital
• Contact: Sang Hyub Lee, MD, PhD
• Phone: 82-2072-2228
• Email: gidoctor[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 26, 2025
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Malignant Biliary Obstruction

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Primary	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.	1 day
Secondary	Stent patency duration	Stent patency duration is defined as number of days between immediately after procedure and occurrence of stent dysfunction.	1 year
Secondary	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.	1 year
Secondary	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.	1 year