A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage

Health-Related Quality of Life in Patients Undergoing Percutaneous Biliary Drainage For Malignant Biliary Obstruction

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03672019

Enrollment

118

Registered

2018-09-14

Start date

2018-09-11

Completion date

2026-09-01

Last updated

2026-07-07

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

Conditions

Malignant Biliary Obstruction

Keywords

Percutaneous Biliary Drainage, Quality of life, 18-366

Brief summary

The purpose of this study is to compare the participant's health-related quality of life before and after the biliary drainage procedure. The study will also help us learn whether having a drainage catheter or a stent placed during the procedure makes a difference in the participant's quality of life.

Interventions

BEHAVIORALFACT-Hep

Patient Reported Outcomes (PRO) assessments at baseline and at three time points post-procedure: 4 weeks (+/- 1 weeks), 12 weeks (+/- 2 weeks), and 6 months (+/- 2 weeks).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with known malignancy presenting for treatment of biliary obstruction * Undergoing initial Interventional Radiology PBD procedure * Fluent in English to enable instrument completion * At least18 years of age * Must be physically and mentally capable of completing instruments * Must be able to comprehend and execute informed consent

Exclusion criteria

* Patients will be excluded if: * Indication for drainage is acute, symptomatic cholangitis requiring an emergent procedure * Previous PBD procedure * Presence of an indwelling biliary stent * Medical or psychiatric condition that, in the judgment of the consenting professional, prevents appropriate comprehension and execution of either the informed consent or the study instruments

Design outcomes

Primary

Measure	Time frame	Description
change in the FACT-Hep scores	baseline to week 4 post-procedure	The FACT-Hep minimum score is 0 and the maximum is 180.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPiera Cote Robson, MSN, CNS, NP

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026