Biodegradable Stents Versus Plastic Stents for Treatment of Biliary Anastomotic Strictures in Liver Transplant RecipIents

Status: Recruiting
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Contact Information
Primary
Tomas Hucl, Prof
tomas.hucl@ikem.cz
420261364016
Backup
Iveta Matulova
iveta.matulova@ikem.cz
420261365154
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 70
Treatments
Experimental: Management of anastomotic biliary strictures with biodegradable stents
Initially, a single biodegradable stent is used for treatment of an anastomotic biliary stricture. If needed, this may be followed by usage of another biodegradable stent or plastic stents.
Active_comparator: Management of anastomotic biliary strictures with multiple plastic stents in
Multiple plastic stents are used for treatment of an anastomotic biliary stricture.
Related Therapeutic Areas
Sponsors
Leads: Institute for Clinical and Experimental Medicine

This content was sourced from clinicaltrials.gov