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Active, Not Recruiting

NCT Number: NCT03672019

A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Malignant Biliary Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: The Functional Assessment of Cancer Therapy

Primary outcomes

  1. change in the FACT-Hep scores

    Time frame: baseline to week 4 post-procedure

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2018
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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