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Non Transplantable Recurrence After Percutaneous Thermal Ablation of HCC

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

HCC

Treatments

Procedure: Percutaneous thermal ablation

Study type

Observational

Funder types

Other

Identifiers

NCT05202184
RECHMPL17_0436_3

Details and patient eligibility

About

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.

Full 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.

Enrollment

213 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

213 participants in 1 patient group

Percutaneous thermal ablation of small HCC
Description:
Percutaneous thermal ablation of small HCC
Treatment:
Procedure: Percutaneous thermal ablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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