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NCT04857424 Clinical Trial

Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage in Biliary Obstruction

Biliary Obstruction Clinical Trial

Official title:
A Comparative Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage of Benign and Malignant Biliary Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04857424
Other study ID # 21-000142
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 15, 2021
Est. completion date December 2024

Study information
Verified date March 2024
Source Mayo Clinic
Contact Karl Akiki, MD
Phone (507)284-4723
Email Akiki.karl@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 206
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with benign biliary obstruction - Patients with malignant biliary obstruction - Patients undergoing ERCP and/or PTBD 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in European Quality of Life-5 Dimensions questionnaire score 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). Baseline, 1 month, 3 months
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