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Starting soon Not applicable

Resection And Partial LIver Transplantation With Delayed Hepatectomy for Hepatocellular Carcinoma

NCT05971628 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-09
Last updated
2023-08-02

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

Sex
ALL
Min age
18 Years
Max age
68 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
AP-HP, Paul Brousse Hospital Villejuif France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05971628 on ClinicalTrials.gov ↗ ← All trials in France