Non Transplantable Recurrence After Percutaneous Thermal Ablation of HCC

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non Transplantable Recurrence After Percutaneous Thermal Ablation of ≤3cm HCC: Predictors and Implications for Treatment Allocation

Conditions
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HCC

Intervention / Treatment
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* Procedure: Percutaneous thermal ablation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : 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). Exclusion criteria: - age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Percutaneous thermal ablation of small HCC<br>Percutaneous thermal ablation of small HCC | Procedure: Percutaneous thermal ablation<br>* All thermoablation procedures were performed percutaneously under ultrasound and/or CT guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of non transplantable recurrence | Incidence of non transplantable recurrence | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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With or without cirrhosis, BCLC0 or A, No extra-hepatic disease, Radiofrequency ablation, Microwave ablation, Liver transplantation