Non Transplantable Recurrence After Percutaneous Thermal Ablation of HCC

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT05202184

Collaborator

(none)

213

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HCC	Procedure: Percutaneous thermal ablation

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.

Study Design

Study Type:

Observational

Actual Enrollment :

213 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Percutaneous thermal ablation of small HCC Percutaneous thermal ablation of small HCC	Procedure: Percutaneous thermal ablation All thermoablation procedures were performed percutaneously under ultrasound and/or CT guidance

Arm

Intervention/Treatment

Percutaneous thermal ablation of small HCC

Procedure: Percutaneous thermal ablation

All thermoablation procedures were performed percutaneously under ultrasound and/or CT guidance

Outcome Measures

Primary Outcome Measures

Incidence of non transplantable recurrence [1 day]
Incidence of non transplantable recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).