Back to resultsEfficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC
Primary Purpose
Malignant Biliary Obstruction, Hepatocellular Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endoscpic biliary drainage using fully covered metal stent
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Biliary Obstruction focused on measuring Self expandable metal stent
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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fully covered self-expanable metal stent with HCC
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Stent patency duration
Stent patency duration is defined as number of days between immediately after procedure and occurrence of stent dysfunction.
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.
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.
Full Information
NCT ID
NCT05729867
First Posted
February 6, 2023
Last Updated
February 14, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05729867
Brief Title
Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC
Official Title
Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable Hepatocellular Carcinoma: A Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
April 26, 2024 (Anticipated)
Study Completion Date
April 26, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Biliary Obstruction, Hepatocellular Carcinoma
Keywords
Self expandable metal stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fully covered self-expanable metal stent with HCC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endoscpic biliary drainage using fully covered metal stent
Intervention 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.
Primary Outcome Measure Information:
Title
Clinical success rate
Description
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
Title
Technical success rate
Description
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 Outcome Measure Information:
Title
Stent patency duration
Description
Stent patency duration is defined as number of days between immediately after procedure and occurrence of stent dysfunction.
Time Frame
1 year
Title
Stent migration rate
Description
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
Title
Stent dysfunction rate
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Hyub Lee, MD, PhD
Phone
82-2072-2228
Email
gidoctor@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Hyub Lee, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Hyub Lee, MD. PhD.
Phone
+82-2-2072-4892
Email
gidoctor@snu.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC
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