Clinical trial · Interventional
Palliative Biliary Stenting on the Quality of Life of Patients With Unresectable Carcinoma Gallbladder With Hiliar Block.
Effect of Palliative Biliary Stenting Versus Conservative Treatment on the Quality of Life (QOL) of Patients With Unresectable Carcinoma of the Gallbladder With Hiliar Block: A Randomised Controlled Trial
NCT00391183CI-TRIAL-00011315completedPhase 2 / Phase 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 purpose of the study is to determine whether palliative biliary stenting improves the quality of life, of gallblader cancer patients, who present with hilar block and obstructive jaundice.
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 |
|---|---|---|---|
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biliary stenting | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Endoscopic stenting
- description
- patients with biliary obstruction will undergo endoscopic stenting.
- interventionNames
- Procedure: Biliary stenting
- type
- NO_INTERVENTION
- label
- Best supportive care
Primary outcomes (1)
- measure
- Improvement in the physical functioning scale (containing five items) of EORTC QLQ-30 one month after after biliary stenting.
- timeFrame
- 30 days
Secondary outcomes (6)
- measure
- Improvements in other functional and social scales and single items of EORTC QLQ-30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with unresectable gallbladder cancer (Bismuth type II to IV). 2. Eastern Cooperative Oncology Group Performance (ECOG) status 0-3. Exclusion Criteria: 1. Preoperative stenting 2. ECOG status 4 3. Distant residence precluding follow up visits, or unwillingness to return for follow up. 4. Poor comprehension of the Hindi QOL questionnaire.
References
Publications (3)
- BACKGROUNDBallinger AB, McHugh M, Catnach SM, Alstead EM, Clark ML. Symptom relief and quality of life after stenting for malignant bile duct obstruction. Gut. 1994 Apr;35(4):467-70. doi: 10.1136/gut.35.4.467. PMID 7513672
- BACKGROUNDLuman W, Cull A, Palmer KR. Quality of life in patients stented for malignant biliary obstructions. Eur J Gastroenterol Hepatol. 1997 May;9(5):481-4. doi: 10.1097/00042737-199705000-00013. PMID 9187881
- BACKGROUNDAbraham NS, Barkun JS, Barkun AN. Palliation of malignant biliary obstruction: a prospective trial examining impact on quality of life. Gastrointest Endosc. 2002 Dec;56(6):835-41. doi: 10.1067/mge.2002.129868. PMID 12447294