A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage

Active, not recruiting

• Conditions: Malignant Biliary Obstruction
• Interventions: Behavioral: FACT-Hep

• Registration Number: NCT03672019
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-11
• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 118

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Undergoing Percutaneous Biliary Drainage	FACT-Hep	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).

Primary Outcome Measures

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

Trial Locations

Locations (5)

Memorial Sloan Kettering Westchester (Consent only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Basking Ridge (Consent only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Commack (Consent only); 🇺🇸 Commack, New York, United States