Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT05971628
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
68 Years
Study:
NCT05971628
Study Brief:
Protocol Section:
NCT05971628