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

NCT04857424 | Completed

• 1 other identifier: 21-000142
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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).

Conditions

Biliary Obstruction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ERCP

Subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP)

PTBD

Subjects with benign and malignant biliary obstruction who have or will undergo percutaneous trans-hepatic biliary drainage (PTBD).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 or over with a diagnosis of benign or malignant biliary obstruction who have underwent an ERCP and/or PTBD will be identified through Best Practices Advisory (BPA), referrals from the clinics of GI consultants and the gastroenterology department procedure schedules at Mayo Clinic, Rochester.

You may qualify if:

• Patients with benign biliary obstruction
• Patients with malignant biliary obstruction
• Patients undergoing ERCP and/or PTBD

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Jad AbiMansour, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 23, 2021
• Study Start: July 15, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)