Skip to main content
OpenTrials
Completed

NCT Number: NCT04857424

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Biliary Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in European Quality of Life-5 Dimensions questionnaire score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.