Clinical trial · Interventional
Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures
Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures: A Prospective, Multi-center Randomized Controlled Trial
NCT00653978CI-TRIAL-00005043unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERCP plus one biliary stent | Procedure | — | UNRESOLVED |
| ERCP plus two biliary stents | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- patients receiving one stent
- interventionNames
- Procedure: ERCP plus one biliary stent
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- patients receiving two stents
- interventionNames
- Procedure: ERCP plus two biliary stents
Primary outcomes (1)
- measure
- Early complications
- timeFrame
- 30 days within treatment
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Consecutive untreated patients with biliary obstruction (Bismuth type II, III) at the hilum due to primary cholangiocarcinoma, gallbladder cancer, or periportal lymph node metastases. Diagnosis is based on US, CT, and MRCP. * Histologic or cytologic confirmation of malignancy is established by percutaneous biopsy (US- or CT-guided) or by endoscopic tissue sampling, endoscopic brushing. Or the diagnosis is based on typical features on imaging and the expected clinical outcome during follow-up. * All patients were considered unsuitable for resection on the basis of general medical condition and/or tumor extent. * Full and informed consent is obtained. Exclusion Criteria: * Refuse to participate in this study. * Refuse to provide informed consent. * Refuse to be placed with plastic stents. * Physically unfit for endoscopic treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.