Clinical trial · Interventional
Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Patients enrollment problem
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Neoplasm | Bile Duct Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Obstructive Jaundice | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| parallel stent | Procedure | — | UNRESOLVED |
| Y-stent (BONASTENT M-Hilar) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- parallel stent
- description
- parallel stent insertion group
- interventionNames
- Procedure: parallel stent
- type
- ACTIVE_COMPARATOR
- label
- Y-stent
- description
- Y-stent insertion group
- interventionNames
- Device: Y-stent (BONASTENT M-Hilar)
Primary outcomes (1)
- measure
- The time taken to insert bilateral stent
- timeFrame
- After the ERCP procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available