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

Study Overview
=================
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.

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

Conditions
-----------------
Malignant Biliary Obstruction, Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: Endoscpic biliary drainage using fully covered metal stent


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fully covered self-expanable metal stent with HCC<br>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. | Procedure: Endoscpic biliary drainage using fully covered metal stent<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent patency duration | Stent patency duration is defined as number of days between immediately after procedure and occurrence of stent dysfunction. | 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. | 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. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Self expandable metal stent