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Trial Title:
Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC
NCT ID:
NCT05729867
Condition:
Malignant Biliary Obstruction
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Self expandable metal stent
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Endoscpic biliary drainage using fully covered metal stent
Description:
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.
Arm group label:
fully covered self-expanable metal stent with HCC
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.
Criteria for 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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sang Hyub Lee, MD. PhD.
Phone:
+82-2-2072-4892
Email:
gidoctor@snu.ac.kr
Start date:
April 27, 2020
Completion date:
April 26, 2025
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05729867
