A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage

NCT03672019 | Active Not Recruiting

• 1 other identifier: 18-366
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 5

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.

Conditions

Malignant Biliary Obstruction

Keywords

Percutaneous Biliary Drainage; Quality of life; 18-366

Outcome Measures

Primary Outcomes (1)

• change in the FACT-Hep scores

  The FACT-Hep minimum score is 0 and the maximum is 180.

  baseline to week 4 post-procedure

Study Arms (1)

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).

Behavioral: FACT-Hep

Interventions

FACT-Hep 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).

Also known as: The Functional Assessment of Cancer Therapy

Patients Undergoing Percutaneous Biliary Drainage

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

Potential research subjects will be identified in the interventional radiology clinic or while admitted based on a request for a biliary drainage procedure from their primary oncologist or surgeon at MSK.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (5)

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Piera Cote Robson, MSN, CNS, NP

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 14, 2018
• Study Start: September 11, 2018
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

US (5)