Using biodegradable stents to treat bile duct issues in liver transplant patients
Official title: Biodegradable Stents Versus Plastic Stents for Treatment of Biliary Anastomotic Strictures in Liver Transplant RecipIents
Run by Institute for Clinical and Experimental Medicine · NCT06716541 · Data updated 2026-11-12
This study is testing if biodegradable stents can help liver transplant patients with bile duct problems feel better and avoid complications compared to regular plastic stents.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Institute for Clinical and Experimental Medicine Government |
| Locations | 1 site (Prague) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | December 4, 2024 |
| Trial ID | NCT06716541 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who have undergone liver transplantation and are experiencing biliary anastomotic strictures.
✕Probably not a fit
Patients with a different type of biliary anastomosis or those who are pregnant will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of biodegradable stents for treating biliary anastomotic strictures in liver transplant recipients. The study aims to assess the effectiveness of these stents compared to traditional plastic stents, which often require multiple procedures and can be costly. Participants will undergo endoscopic retrograde cholangiopancreatography (ERCP) for stent implantation, with the goal of reducing complications associated with biliary strictures. The trial will evaluate patient outcomes and the stents' performance in alleviating symptoms and preventing graft failure.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for repeated procedures and improve the quality of life for liver transplant recipients.
How similar studies have gone: While the use of biodegradable stents has shown promise in treating benign biliary strictures, data on their use specifically in liver transplant recipients is limited, making this a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Liver transplant recipients * Duct-to-duct biliary anastomosis * Anastomotic biliary stricture (cholestasis unexplained by other causes and/or liver biopsy showing altered biliary drainage and/or anastomotic stricture on MRCP) * Signed informed consent Exclusion Criteria: * Hepaticojejunoanastomosis * Physical and/or psychological inability to understand the aims of the research and to adequately cooperate * Pregnancy
Where it's running
-
Institute for Clinical and Experimental Medicine, Department of Gastroenterology and Hepatology
Prague, Czechia Recruiting
Study contacts
- Principal investigator: Tomas Hucl, Prof — Institute for Clinical and Experimental Medicine
- Study coordinator: Tomas Hucl, Prof
- Email: tomas.hucl@ikem.cz
- Phone: 420261364016
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.