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Clinical Trials/NCT03672019
NCT03672019
Active, Not Recruiting
N/A

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

Memorial Sloan Kettering Cancer Center5 sites in 1 country118 target enrollmentSeptember 11, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malignant Biliary Obstruction
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
118
Locations
5
Primary Endpoint
change in the FACT-Hep scores
Status
Active, Not Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 11, 2018
End Date
September 1, 2026
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (5)

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