Malignant Hepatobiliary Neoplasm
Conditions
Brief summary
The purpose of this study was to compare the difference in the stent patency duration between side-by-side fully covered self-expanding metal stents (SEMS) and side-by-side plastic stents in patients with malignant hilar biliary obstruction.
Detailed description
In the case of distal common bile duct obstruction, the SEMS was reported to be clinically superior to the plastic stent in previous studies. However, there are few studies comparing the two methods in patients with malignant hilar biliary obstruction. In contrast to the distal common bile duct obstruction, the advantage of plastic stents over SEMSs exists, and plastic stents are used commonly in real clinical practice.
Interventions
PROCEDUREendoscopic retrograde cholangio-pancreatography
In patients who were identified to have malignant hilar biliary obstruction, bilateral stents insertion is attempted via ERCP. There will be two groups divided by stent material; FCSEMS and Plastic stent.
Sponsors
Taewoong Medical Co., Ltd.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Unresectable malignant hilar biliary stricture requiring biliary drainage through endoscopic procedure
Exclusion criteria
* If endoscopy is not possible based on the judgement of the researcher * Life expectancy less than 6 months * Acute cholecystitis * Previous history of percutaneous transhepatic biliary drainage * Previous history of metal stent placement for malignant biliary stricture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of stent patency | 9 months after randomization. | The period from the insertion of the stent to the point at which stent revision is required. |
Countries
South Korea
Contacts
Primary ContactMin su You, MD
Backup ContactWoo Hyun Paik, MD, PhD
Outcome results
None listed