Status:
NOT_YET_RECRUITING
Resection And Partial LIver Transplantation With Delayed Hepatectomy for Hepatocellular Carcinoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-68 years
Phase:
NA
Brief Summary
This is a national, non-randomized, multicentric trial evaluating the feasibility and the tolerance of the RAPID procedure in patients with HCC with preserved liver function requiring a liver transpla...
Detailed Description
In France, the liver transplant allocation is based on the severity of liver failure, but patients with hepatocellular carcinoma (HCC) usually do not have hepatocellular failure, resulting in reduced ...
Eligibility Criteria
Inclusion
- Inclusion criteria (RAPID receiver)
- 18 years ≤ age ≤ 68 years
- Indication of LT for HCC validated in multidisciplinary meeting
- AFP score ≤ 2 (15)
- Body mass index \< 30 kg/m2
- MELD score ≤ 15, without access to prioritization
- PET CT-choline and PET CT-FDG without sign of extra-hepatic localizaton
- Patient having been informed and able to give written consent to participate in the RAPID-HCC study
- Validation of the patient's inclusion in the RAPID-HCC protocol by the scientific committee
- Exclusion criteria
- History of, liver transplant, surgical or radiological portocaval anastomosis
- History of major abdominal surgery (including hepatectomy)
- History of abdominal radiotherapy (extrahepatic)
- History of acute/chronic pancreatitis
- Expected combined transplant
- HCC located 1 cm away from the transection line required by the first stage hepatectomy
- Portal or arterial thrombosis
- patient with a pre-graft hepatic venous pressure gradient ≥ 20mmHg
- Ascites (clinical or radiological) less than 5 years ago
- Hepatitis C viral load +
- Acute or chronic hepatitis B (not cured)
- HIV + serology
- Severe comorbidities, in particular severe cardiovascular or respiratory or renal pathology (at the discretion of the medical-surgical team)
- Patient on anticoagulant treatment
- Patient who has received (or is due to receive) preoperative treatment with radioembolization on the right side, hepatectomy or radiotherapy near the hilum
- Patient who received (or should receive) preoperative treatment with anti-tyrosine kinase (TKI) less than three months ago
- Patients receiving or having received immunotherapy
- Donor selection criteria:
- Brain-dead donor (no living donor)
- 18 years ≤ age ≤ 65 years
- Hepatic, vascular and biliary anatomy compatible with performing a split. Analysis entrusted to the team that will carry out the split, and based on the scanner of the donor (to be available on the Biomedicine Agency website)
- Biological and hepatic assessment compatible with the realization of a split, in particular transaminases \< 4 times the normal
- Graft not assigned to a protocol requiring machine infusion.
- Serology: anti-HBc negative, anti-HCV negative
Exclusion
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05971628
Start Date
September 1 2023
End Date
June 1 2029
Last Update
August 2 2023
Active Locations (1)
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1
AP-HP, Paul Brousse Hospital
Villejuif, France, 94800