Clinical trial NCT05202184: Non Transplantable Recurrence After Percutaneous Thermal Ablation of HCC
Official title: Non Transplantable Recurrence After Percutaneous Thermal Ablation of ≤3cm HCC: Predictors and Implications for Treatment Allocation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC
Keywords: With or without cirrhosis
BCLC0 or A
No extra-hepatic disease
Radiofrequency ablation
Microwave ablation
Liver transplantation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing PTA for HCC between January 2015 and December 2020 were included. Data were collected from our prospective database at the Department of Radiology St-Eloi University Hospital - Montpellier School of Medicine France.

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.

Eligibility 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

Primary outcomes:
measure: Incidence of non transplantable recurrence
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: BORIS GUIU, PU-PH
role: STUDY_DIRECTOR
References: