Using biodegradable stents to treat bile duct issues in liver transplant patients
Biodegradable Stents Versus Plastic Stents for Treatment of Biliary Anastomotic Strictures in Liver Transplant RecipIents
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute for Clinical and Experimental Medicine Government |
| Locations | 1 site (Prague) |
| Trial ID | NCT06716541 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have undergone liver transplantation and are experiencing biliary anastomotic strictures.
Not a fit: Patients with a different type of biliary anastomosis or those who are pregnant will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Prague
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.