A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage (NCT03672019) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage
United States118 participantsStarted 2018-09-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.