NCT05971628Not yet recruiting
Resection And Partial LIver Transplantation With Delayed Hepatectomy for Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 2 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 30 Jun 2023
- Start date
- Sept 2023
- Primary completion date
- Oct 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05971628
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Sept 2023 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Expected combined transplant
- Severe comorbidities, in particular severe cardiovascular or respiratory or renal pathology (at the discretion of the medical-surgical team)
- 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:
Other illness
- 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
- Portal or arterial thrombosis
- Hepatitis C viral load +
- Acute or chronic hepatitis B (not cured)
- HIV + serology
- Serology: anti-HBc negative, anti-HCV negative
Lab values
- Biological and hepatic assessment compatible with the realization of a split, in particular transaminases \< 4 times the normal
Age
- 18 years ≤ age ≤ 65 years
Other
- HCC located 1 cm away from the transection line required by the first stage hepatectomy
- patient with a pre-graft hepatic venous pressure gradient ≥ 20mmHg
- Ascites (clinical or radiological) less than 5 years ago
- Patient on anticoagulant treatment
- Brain-dead donor (no living donor)
- 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)
- Graft not assigned to a protocol requiring machine infusion.
Who the study is looking for
- 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
Age in the registry: 18 years to 68 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AP-HP, Paul Brousse Hospital Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.