Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Samsung Medical Center
- Locations
- 1
- Primary Endpoint
- The time taken to insert bilateral stent
Study Overview
Brief Summary
Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.
Bilateral drainage is more physiologic and have more long patency than unilateral drainage.
There are two methods of bilateral drainage: Y-stent and side by side.
However there are no clinical data about comparing the effectiveness of these two methods.
Therefore the investigators want to compare the clinical outcomes of two methods:
Y-stent and side by side.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥ 18 years
- •patient who have obstructive jaundice (bilirubin > 2.0mg/dl) due to hilar malignancy
Exclusion Criteria
- •patients with endoscopic retrograde cholangiogram is not possible
- •bleeding tendency (PT INR > 1.5, platelet < 50,000)
- •poor general condition (ECOG 3-4) or cardiopulmonary deterioration
- •pregnancy
Arms & Interventions
Y-stent
Y-stent insertion group
Intervention: Y-stent (BONASTENT M-Hilar) (Device)
parallel stent
parallel stent insertion group
Intervention: parallel stent (Procedure)
Outcomes
Primary Outcomes
The time taken to insert bilateral stent
Time Frame: After the ERCP procedure
Secondary Outcomes
No secondary outcomes reported
Investigators
Kwang Hyuck Lee
Assistant Professor of Medicine
Samsung Medical Center