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

N/AActive Not RecruitingNCT04857424

Mayo Clinic206 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

206

Conditions

Biliary Obstruction

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline, 1 month, 3 months

Data from ClinicalTrials.gov

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