NCT03672019
Active, Not Recruiting
N/A
Health-Related Quality of Life in Patients Undergoing Percutaneous Biliary Drainage For Malignant Biliary Obstruction
ConditionsMalignant Biliary Obstruction
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Malignant Biliary Obstruction
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 118
- Locations
- 5
- Primary Endpoint
- change in the FACT-Hep scores
- Status
- Active, Not Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
The purpose of this study is to compare the participant's health-related quality of life before and after the biliary drainage procedure. The study will also help us learn whether having a drainage catheter or a stent placed during the procedure makes a difference in the participant's quality of life.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with known malignancy presenting for treatment of biliary obstruction
- •Undergoing initial Interventional Radiology PBD procedure
- •Fluent in English to enable instrument completion
- •At least18 years of age
- •Must be physically and mentally capable of completing instruments
- •Must be able to comprehend and execute informed consent
Exclusion Criteria
- •Patients will be excluded if:
- •Indication for drainage is acute, symptomatic cholangitis requiring an emergent procedure
- •Previous PBD procedure
- •Presence of an indwelling biliary stent
- •Medical or psychiatric condition that, in the judgment of the consenting professional, prevents appropriate comprehension and execution of either the informed consent or the study instruments
Outcomes
Primary Outcomes
change in the FACT-Hep scores
Time Frame: baseline to week 4 post-procedure
The FACT-Hep minimum score is 0 and the maximum is 180.
Study Sites (5)
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