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

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ClinicalTrials.gov Identifier: NCT04857424
Recruitment Status : Not yet recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Andrew C. Storm, Mayo Clinic

Brief Summary:
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).

Condition or disease
Biliary Obstruction

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Study Type : Observational
Estimated Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparative Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage of Benign and Malignant Biliary Obstruction
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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



Primary Outcome Measures :
  1. Change in European Quality of Life-5 Dimensions questionnaire score [ Time Frame: Baseline, 1 month, 3 months ]
    Measured using the European Quality of Life-5 Dimensions questionnaire that measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The Euro-QOL-5D score is derived from adding the scores from each of the five items. The best possible score is five (i.e., asymptomatic in each item) and the worst possible score is 15 (incapacitated in each item).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients aged 18 or over with a diagnosis of benign or malignant biliary obstruction who have underwent an ERCP and/or PTBD will be identified through Best Practices Advisory (BPA), referrals from the clinics of GI consultants and the gastroenterology department procedure schedules at Mayo Clinic, Rochester.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857424


Contacts
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Contact: William C Winter 507-422-5673 Winter.William@mayo.edu
Contact: Tala Mahmoud, MD Mahmoud.Tala@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Andrew Storm, MD Mayo Clinic
Additional Information:
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Responsible Party: Andrew C. Storm, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04857424    
Other Study ID Numbers: 21-000142
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No