Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage in Biliary Obstruction
Recruiting
- Conditions
- Biliary Obstruction
- Registration Number
- NCT04857424
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The aim of this study is to compare the quality of life in subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous trans-hepatic biliary drainage (PTBD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 206
Inclusion Criteria
- Patients with benign biliary obstruction
- Patients with malignant biliary obstruction
- Patients undergoing ERCP and/or PTBD
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Exclusion Criteria
- Patients with gallstone disease
- Patients who will undergo ERCP who have previously underwent a PTBD
- Patients who will undergo PTBD who have previously underwent an ERCP
- Female patients who are pregnant
- Prisoners and other vulnerable populations
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in European Quality of Life-5 Dimensions questionnaire score Baseline, 1 month, 3 months Measured using the European Quality of Life-5 Dimensions questionnaire that measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The Euro-QOL-5D score is derived from adding the scores from each of the five items. The best possible score is five (i.e., asymptomatic in each item) and the worst possible score is 15 (incapacitated in each item).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States