Resection And Partial LIver Transplantation With Delayed Hepatectomy for Hepatocellular Carcinoma
RAPID-HCC
1 other identifier
interventional
50
1 country
1
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 transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hepatocellular-carcinoma
Started Sep 2023
Longer than P75 for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2023
CompletedFirst Posted
Study publicly available on registry
August 2, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
August 2, 2023
June 1, 2023
4.1 years
June 30, 2023
July 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of patient with successful RAPID procedure
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.
4 months after the second RAPID step
Tolerance of the RAPID procedure
Tolerance will be assessed with Adverse events related to the procedure
from first stage of the surgical protocol and until 90 days after the second stage
Secondary Outcomes (10)
Proportion of grafts in place
4 months after the first surgical step
Survival of grafts at 2 years from liver transplantation (LT)
at 2 Years from LT
Survival of patient at 2 year after their registration on the waiting list of transplantation
at 2 year after their registration on the waiting list of transplantation
Survival of patient at 2 year after LT
at 2 year after LT
Incidence of rejection after RAPID
at 2 years after the first stage of RAPID
- +5 more secondary outcomes
Study Arms (2)
Liver transplantation with the RAPID procedure
EXPERIMENTALLiver transplantation for hepatocellular carcinoma according to the RAPID protocol. This protocol is an auxiliary liver transplantation of a partial graft with total hepatectomy in two stages (2 successive operations).
Comparator group with standard liver transplantation (whole graft)
NO INTERVENTIONOrthotopic liver transplantation with whole organ from deceased donor for hepatocellular carcinoma. Data will be provided by Biomedicine Agency, following pairing rules.
Interventions
RAPID procedure stands for Resection And Partial Liver Transplantation with Delayed Hepatectomy for hepatocellular carcinoma
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AP-HP, Paul Brousse Hospital
Villejuif, 94800, France
Related Publications (1)
Peloso A, Pietrasz D, Daillier E, Cylly L, Scatton O, Goumard C, Mabrut JY, Mohkam K, Lesurtel M, Dokmak S, Jeddou H, Boudjema K, Allard MA, Adam R, Sa Cunha A, Azoulay D, Cherqui D, Vibert E, Golse N. Resection and partial liver transplantation from deceased donors with delayed total hepatectomy (RAPID procedure) for hepatocellular carcinoma: a national, multicenter, non-randomized, prospective trial. BMC Cancer. 2025 May 9;25(1):848. doi: 10.1186/s12885-025-14127-7.
PMID: 40346479DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas GOLSE, Doctor
APHP, Paul Brousse Hospital, villejuif, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2023
First Posted
August 2, 2023
Study Start
September 1, 2023
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
June 1, 2029
Last Updated
August 2, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share