A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-11

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Malignant Biliary Obstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients Undergoing Percutaneous Biliary Drainage

Following Percutaneous Biliary Drainage (PBD), participants will complete 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).

FACT-Hep

Intervention Type BEHAVIORAL

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).

Interventions

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FACT-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).

Intervention Type BEHAVIORAL

Other Intervention Names

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The Functional Assessment of Cancer Therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No