Hepatocellular Carcinoma, Malignant Biliary Obstruction
Conditions
Keywords
Self expandable metal stent
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.
Interventions
PROCEDUREEndoscpic 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.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactSang Hyub Lee, MD, PhD
Outcome results
None listed