Using a temporary shunt during liver transplantation to improve outcomes from extended criteria donors
APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor
This study is testing whether using a temporary shunt during liver transplants can help improve the function of livers from donors who may not be the healthiest.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 6 sites (Bordeaux and 5 other locations) |
| Trial ID | NCT02784119 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of a temporary porto-caval shunt during liver transplantation to enhance the function of liver grafts obtained from extended criteria donors. The study aims to address the challenges posed by ischemia-reperfusion injury, which can lead to primary non-function or early allograft dysfunction in these grafts. By implementing a shunt during the anhepatic phase of transplantation, the trial seeks to reduce complications associated with blood congestion and inflammatory responses. The trial includes adult candidates for liver transplantation with specific eligibility criteria related to donor characteristics and patient health status.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are awaiting liver transplantation and meet specific criteria related to cirrhosis and donor characteristics.
Not a fit: Patients with fulminant hepatitis, those requiring retransplantation, or those receiving combined organ transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the viability and function of liver grafts from extended criteria donors, potentially increasing transplant success rates.
How similar studies have performed: While the use of temporary porto-caval shunts is a novel approach in this context, similar strategies have shown promise in other surgical settings, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * Candidate of liver transplantation * With cirrhosis from any etiology * Model For End-Stage Liver Disease (MELD) score \< 25 * Transplanted with a liver graft harvested from an extended criteria donor defined as presence of at least one of the following criteria: * Donor age \> 65 years old * Intensive care unit stay \> 7 days * BMI \> 30 * Natremia \> 155 mmol/L * Aspartate aminotransferase (ASAT) \> 150 IU/mL * Alanine aminotransferase (ALAT) \> 170 IU/mL * Occurrence of a cardiac arrest before graft harvesting * Proven biopsy macrosteathosis \> 30% * Non-opposition from the patient Non Inclusion Criteria: * Fulminant hepatitis * Retransplantation * Combined organ transplantation (kidney, pancreas, heart, lung) * Non heart beating donor * Complete portal vein thrombosis on preoperative imaging finding Exclusion Criteria: * Complete portal vein thrombosis found during procedure * Split liver graft * Realisation of a bilio-enteric anastomosis
Where this trial is running
Bordeaux and 5 other locations
- CHU Bordeaux — Bordeaux, France (Recruiting)
- Hospices Civils Lyon — Lyon, France (Recruiting)
- CHU Nice — Nice, France (Recruiting)
- CHU Rennes — Rennes, France (Recruiting)
- CHU Toulouse — Toulouse, France (Recruiting)
- CHU Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Michel RAYAR, MD, PhD
- Email: michel.rayar@chu-rennes.fr
- Phone: 02 99 28 42 65
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.