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

NCT06716541 | Recruiting

• 1 other identifier: IKEM BDS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant, Complications; Biliary Anastomotic Stenosis; Endoscopic Retrograde Cholangiopancreatography

Outcome Measures

Primary Outcomes (2)

• 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)

  12+6 months

• Number of ERCPs

  The total number of ERCPs required for the stricture resolution

  12 months

Secondary Outcomes (8)

• Initial anastomotic stricture resolution

  12 months

• Technical feasibility

  12 months

• Safety

  12 months

• Number of stents placed

  12 months

• Duration of stenting

  12 months

Study Arms (2)

Management of anastomotic biliary strictures with biodegradable stents

EXPERIMENTAL

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.

Procedure: ERCP implantation of a biodegradable stent; Procedure: ERCP implantation of plastic stents

Management of anastomotic biliary strictures with multiple plastic stents in

ACTIVE COMPARATOR

Multiple plastic stents are used for treatment of an anastomotic biliary stricture.

Procedure: ERCP implantation of plastic stents

Interventions

ERCP implantation of a biodegradable stent PROCEDURE

Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a biodegradable stent to treat anastomotic biliary stricture (possibly combined with removal of previous plastic stents).

Management of anastomotic biliary strictures with biodegradable stents

ERCP implantation of plastic stents PROCEDURE

Endoscopic 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).

Management of anastomotic biliary strictures with biodegradable stents; Management of anastomotic biliary strictures with multiple plastic stents in

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hepaticojejunoanastomosis
• Physical and/or psychological inability to understand the aims of the research and to adequately cooperate
• Pregnancy

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine, Department of Gastroenterology and Hepatology

Prague, 140 21, Czechia

RECRUITING

Study Officials

• Tomas Hucl, Prof

  Institute for Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Hucl, Prof

CONTACT

420261364016; tomas.hucl@ikem.cz

Iveta Matulova

CONTACT

420261365154; iveta.matulova@ikem.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 4, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

CZ (1)