Actively Recruiting
Biodegradable Stents Versus Plastic Stents for Treatment of Biliary Anastomotic Strictures in Liver Transplant Recipients
Led by Institute for Clinical and Experimental Medicine · Updated on 2024-12-04
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Biliary complications after liver transplantation are common and can lead to serious health issues including liver graft failure. Anastomotic biliary strictures are the most frequent type of biliary stricture following liver transplant. Researchers are studying biodegradable stents, a new type of stent made from synthetic materials, to see if they are as effective as the current standard treatments using multiple plastic stents. This study aims to compare how well these biodegradable stents resolve biliary strictures and to assess their safety and technical use. The study compares two treatments for biliary anastomotic strictures after liver transplantation. One group receives biodegradable stents placed endoscopically via ERCP, potentially followed by additional stents if needed. The other group receives multiple plastic stents through repeated ERCP procedures. The biodegradable stents may reduce the number of ERCPs needed and avoid stent migration risks. The study is randomized and participants are assigned to one of these two treatments to evaluate outcomes. Participants will be followed for at least 12 months to monitor stricture resolution, number of ERCP procedures, stent placement, safety, and quality of life. Assessments include imaging to check the bile duct, liver function tests, and monitoring for complications. The study also tracks how well the biodegradable stents degrade over six months. Results will help determine if biodegradable stents are a feasible and safe alternative to multiple plastic stents for treating biliary strictures after liver transplant.
CONDITIONS
Brief Title
Biodegradable Stents in Liver Transplant RecipIents for Treatment of Biliary Anastomotic Strictures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Liver transplant recipients
- Duct-to-duct biliary anastomosis
- Presence of anastomotic biliary stricture confirmed by cholestasis, liver biopsy, or MRCP imaging
- Signed informed consent
You will not qualify if you...
- Presence of hepaticojejunoanastomosis
- Physical or psychological inability to understand the study or cooperate
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive endoscopic retrograde cholangiopancreatography (ERCP) to place either a biodegradable stent or multiple plastic stents to treat anastomotic biliary strictures. Additional stents may be placed if needed.
Multiple ERCP procedures scheduled every 1 to 3 months, typically 3-4 procedures
Duration - Up to 6 months after treatment
Participants are monitored for stricture resolution, stent degradation, safety, and quality of life after completion of stent treatment.
Visits scheduled for assessment of stricture resolution and stent degradation
Trial Site Locations
Total: 1 location
1
Institute for Clinical and Experimental Medicine, Department of Gastroenterology and Hepatology
Prague, Czechia, 140 21
Actively Recruiting
Research Team
T
Tomas Hucl, Prof
I
Iveta Matulova
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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