A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Malignant Biliary Obstruction

Treatments: Behavioral: FACT-Hep

Study type: Observational

Funder types: Other

Identifiers

NCT03672019

18-366

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

118 participants in 1 patient group

Patients Undergoing Percutaneous Biliary Drainage

Description:

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).

Treatment:

Behavioral: FACT-Hep