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Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage in Biliary Obstruction

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Mayo Clinic

Status

Active, not recruiting

Conditions

Biliary Obstruction

Study type

Observational

Funder types

Other

Identifiers

NCT04857424
21-000142

Details and patient eligibility

About

The aim of this study is to compare the quality of life in subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous trans-hepatic biliary drainage (PTBD).

Enrollment

206 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with benign biliary obstruction
  • Patients with malignant biliary obstruction
  • Patients undergoing ERCP and/or PTBD

Exclusion criteria

  • Patients with gallstone disease
  • Patients who will undergo ERCP who have previously underwent a PTBD
  • Patients who will undergo PTBD who have previously underwent an ERCP
  • Female patients who are pregnant
  • Prisoners and other vulnerable populations

Trial design

206 participants in 2 patient groups

ERCP
Description:
Subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP)
PTBD
Description:
Subjects with benign and malignant biliary obstruction who have or will undergo percutaneous trans-hepatic biliary drainage (PTBD).

Trial contacts and locations

1

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Central trial contact

Tala Mahmoud, MD; Karl Akiki, MD

Data sourced from clinicaltrials.gov

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