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.
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)
Hepaticojejunoanastomosis
Physical and/or psychological inability to understand the aims of the research and to adequately cooperate
Pregnancy
Parallel
ERCP implantation of a biodegradable stent
Procedure/SurgeryEndoscopic retrograde cholangiopancreatography (ERCP) with placement of a biodegradable stent to treat anastomotic biliary stricture (possibly combined with removal of previous plastic stents).
ERCP implantation of plastic stents
Procedure/SurgeryEndoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic stent or multiple stents to treat anastomotic biliary stricture (possibly combined with removal of previous plastic stents).
Persisting anastomotic stricture resolution
Rate of resolution of the anastomotic stricture as confirmed by Endoscopic retrograde cholangiopancreatography (ERCP) or Magnetic Resonance Cholangiopancreatography (MRCP) examination within 12 months since the initial procedure and persistence of the resolution (confirmed by MRCP) 6 months after the initial resolution. Resolution of anastomotic stricture is defined as all of the following simultaneously: * no need of further restenting * residual narrowing of lumen less than 20%) * alkaline phosphatase (ALP) below two times the upper limit of normal (unless a cause of the increase other than the anastomotic stricture is identified)
Number of ERCPs
The total number of ERCPs required for the stricture resolution
Initial anastomotic stricture resolution
Rate of resolution of the anastomotic stricture as confirmed by Endoscopic retrograde cholangiopancreatography (ERCP) or Magnetic Resonance Cholangiopancreatography (MRCP) examination within 12 months since the initial procedure. Resolution of anastomotic stricture is defined as all of the following simultaneously: * no need of further restenting * residual narrowing of lumen less than 20%) * alkaline phosphatase (ALP) below two times the upper limit of normal (unless a cause of the increase other than the anastomotic stricture is identified)
Technical feasibility
Specific technical features related to the biodegradable stent (loadability, pushability, stent deployment, fluoroscopic visibility) and overall technical performance compared to commonly used plastic stents will be evaluated by endoscopists using a questionnaire at the end of the treatment period.
Safety
Device or procedure related adverse events (bleeding, perforation, cholangitis, pancreatitis, stent migration)
Number of stents placed
The total number of stents placed during ERCPs
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