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Stent across bile leak for Bile Leak
N/A
Waitlist Available
Led By James Buxbaum, M.D.
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 5 weeks
Awards & highlights
Study Summary
This trial is testing whether placing a biliary stent across the leak or just across the papilla improves the treatment of biliary leaks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 5 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 5 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with resolution of bile leak by cholangiography
Secondary outcome measures
Proportion of patients who required surgery
Time to from ERCP to remove surgical drain
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Stent across bile leakExperimental Treatment1 Intervention
Stent placement across the bile leak (with a longer stent) for biliary leak
Group II: Transpapillary StentsActive Control1 Intervention
Stent placement across the Papilla (with a short plastic stent) for biliary leak
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,186 Total Patients Enrolled
James Buxbaum, M.D.Principal InvestigatorUSC Health Sciences Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If your bile duct has been completely cut into two parts, you will not be able to participate because this condition cannot be treated with endoscopic therapy.You will be excluded from the study if you have a suspected bile leak that is not caused by surgery, such as from cancer, injury, or other rare causes.If you had surgery recently and there is a suspicion of bile leaks within two weeks, you will not be included in the study.After surgery on your liver or gallbladder, you continue to have a lot of bile fluid draining from surgical drains.
Research Study Groups:
This trial has the following groups:- Group 1: Transpapillary Stents
- Group 2: Stent across bile leak
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has enrollment for this investigation commenced?
"Data hosted on clinicaltrials.gov reveals that this medical study, initially posted in November 2016 and edited most recently in December 2021, is not currently enrolling patients. That being said, there are alternative studies seeking participants at the present moment."
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