Non Transplantable Recurrence After Percutaneous Thermal Ablation of ≤3cm HCC: Predictors and Implications for Treatment Allocation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HCC
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 213
- Locations
- 1
- Primary Endpoint
- Incidence of non transplantable recurrence
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Percutaneous thermal ablation (PTA), resection and liver transplantation (LT) are the standard curative options for hepatocellular carcinoma (HCC). LT yields the best long-term outcomes but is limited by graft shortage. Thus, patients with ≤3cm HCC are mainly treated by PTA although recurrence is frequent and may occur outside transplant criteria. However, data on non transplantable recurrence (NTR) following PTA are lacking. Therefore, the investigators investigated the incidence and predictors of NTR among transplantable patients with ≤3cm HCC(s) treated by PTA, in order to stratify them according to their NTR risk and to improve treatment allocation.
Detailed Description
Consecutive patients undergoing PTA for HCC between January 2015 and December 2020 were included. Data were collected from our prospective database. This study was approved by our institutional review board (NCT03428321 \[www.clinicaltrials.gov\]) and written informed consent was obtained from all patients. Inclusion criteria were: HCC diagnosed by histopathology or by EASL imaging criteria, HCC ≤30mm, 1 - 3 tumor nodules, follow-up\<3 months, no prior or combined treatment with intra-arterial therapy, potentially transplantable patient (ie, ≤70yr, AFP-score≤2 (7), no macroscopic portal vein invasion or extra-hepatic metastasis, no major comorbidity precluding LT). Patient's and liver's characteristics were collected including: age, sex, HCC-naïve status, body mass index (BMI), diabetes mellitus, liver steatosis, cirrhosis, cause for hepatopathy, AFP serum level, Child-Pugh, MELD and Albumin-Bilirubin (ALBI) scores and preablative biological data. Occurrence of NTR after PTA will be analyzed in a competing risks framework, with transplantation and death as competing events. Covariates associated with NTR were analyzed using Fine-Gray proportional sub-distribution hazards models. Recurrence-free survival (RFS) will be defined as the time from PTA until the first recurrence, death, or last follow-up. OS will be defined as the interval between PTA and death (any cause) or last follow-up. Survival curves will be estimated using the Kaplan-Meier method and compared with the log-rank test.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of non transplantable recurrence
Time Frame: 1 day
Incidence of non transplantable recurrence