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Resection And Partial LIver Transplantation With Delayed Hepatectomy for Hepatocellular Carcinoma
Condition(s) studied
Hepatocellular Carcinoma
Investigational drug(s) / intervention(s)
RAPID procedure
RAPID procedure: RAPID procedure stands for Resection And Partial Liver Transplantation with Delayed Hepatectomy for hepatocellular carcinoma
Study 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 transplantation.
Eligibility
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
Primary outcome measure(s)
- Proportion of patient with successful RAPID procedure — 4 months after the second RAPID step
Success of the procedure will be assessed as a patient :
* who complete the 2 steps of the procedure,
* who had no graft resection and who is still alive 4 months later.
- Tolerance of the RAPID procedure — from first stage of the surgical protocol and until 90 days after the second stage
Tolerance will be assessed with Adverse events related to the procedure
Trial sites (1)
| Facility | City | Region | Status |
| AP-HP, Paul Brousse Hospital |
Villejuif |
France |
|
More Assistance Publique - Hôpitaux de Paris trials in France
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