NCT06716541 Biodegradable Stents in Liver Transplant RecipIents for Treatment of Biliary Anastomotic Strictures
| NCT ID | NCT06716541 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute for Clinical and Experimental Medicine |
| Condition | Liver Transplant, Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-11-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Biliary complications after liver transplantation (LT) remain common and are associated with higher morbidity in liver transplant recipients and liver graft failure. Anastomotic biliary strictures are the most common biliary strictures after LT. Today, the gold standard for treatment remains endoscopic retrograde cholangiopancreatography (ERCP) with either multiple plastic stenting (MPS) or fully covered metal stents. These methods have disadvantages such as the need for repeated ERCP procedures, high costs or the risk of migration. Biodegradable stents (BDS) are a novel type of stents made from various synthetic polymers or their copolymers, which are now being used in a variety of medical fields, including the pancreatobiliary tract.The use of biodegradable stents has shown good potential in the treatment of benign biliary strictures. However, overall data on their endoscopic use in liver transplant recipients, particularly in the treatment of anastomotic biliary strictures, are scarce. Most studies have either been in animal models, using percutaneously implanted stents, or in non-transplanted patients. There are no randomised controlled trials investigating their use in LT patients. Based on the available evidence, the use of BDS in the treatment of anastomotic biliary strictures in liver transplant recipients appears to be a promising technique that may be as effective as the standard treatment with MPS, but may reduce the number of ERCP procedures and eliminate the risk of migration. The aim of this randomised prospective study is to compare the difference in rates of anastomotic stricture resolution between the active (BDS) and control (MPS) groups to demonstrate non-inferiority of the biodegradable stents. Outcomes will be classified as complete resolution (no significant stricture at the anastomotic site on imaging and resolution of cholestasis), significant response (relative stricture and resolution of cholestasis) or failure (persistent stricture and/or persistent cholestasis). Secondary outcomes are technical feasibility, immediate and late complications.
Eligibility 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
Contact & Investigator
Tomas Hucl, Prof
PRINCIPAL INVESTIGATOR
Institute for Clinical and Experimental Medicine
Frequently Asked Questions
Who can join the NCT06716541 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Transplant, Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06716541 currently recruiting?
Yes, NCT06716541 is actively recruiting participants. Contact the research team at tomas.hucl@ikem.cz for enrollment information.
Where is the NCT06716541 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT06716541 clinical trial?
NCT06716541 is sponsored by Institute for Clinical and Experimental Medicine. The principal investigator is Tomas Hucl, Prof at Institute for Clinical and Experimental Medicine. The trial plans to enroll 70 participants.