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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04857424

Enrollment

121

Registered

2021-04-23

Start date

2021-07-15

Completion date

2026-03-31

Last updated

2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Obstruction

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJad AbiMansour, MD

Mayo Clinic

Outcome results