Non Transplantable Recurrence After Percutaneous Thermal Ablation of HCC

Completed

• Conditions: HCC
• Interventions: Procedure: Percutaneous thermal ablation

• Registration Number: NCT05202184
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-30
• Status Verified: 2022-01
• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-21
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Percutaneous thermal ablation of small HCC	Percutaneous thermal ablation	Percutaneous thermal ablation of small HCC

Primary Outcome Measures

Name	Time	Method
Incidence of non transplantable recurrence	1 day	Incidence of non transplantable recurrence

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France