Clinical trial · Observational
Quality Of Life in Patients With Malignant Biliary Obstruction
Impact of Biliary Drainage on Quality Of Life in Patients With Malignant Biliary Obstruction
NCT00579865CI-TRIAL-00003022completedClinicalTrials.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)
You may have symptoms like itching, abdominal pain, loss of appetite, fatigue, fevers and chills. The treatment you will receive to relieve the blockage is also intended to relieve symptoms and improve your quality of life. The purpose of this study is to find out if relieving the blockage in your bile duct improves your quality of life.
Conditions
Conditions (3)
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 Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group A
- description
- Patients scheduled for percutaneous drainage
- interventionNames
- Behavioral: questionnaires
- label
- Group B
- description
- Patients scheduled for a surgical bypass or resection of a high bile duct tumor.
- interventionNames
- Behavioral: questionnaires
Primary outcomes (1)
- measure
- To determine how surgical or percutaneous drainage affects HRQL scores in patients with MBO, and to determine if these changes are sustained or change over time.
- timeFrame
- conclusion of the study
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of malignant biliary obstruction * Radiologic or histologic evidence of MBO * Percutaneous biliary drainage procedure planned or * Surgical biliary enteric bypass, or hepatic resection with biliary reconstruction (high bile duct tumors) planned * KPS \>50% * Age 18 years or greater * Able to speak and read English * Able to comprehend and execute informed consent * Prior intervention for MBO not exclusionary Exclusion Criteria: * Unable to complete questionnaire due to performance status * Proxy completion is not accepted * Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument
References
Publications (0)
Data not yet available
No reference posted for this study.