Non Transplantable Recurrence After Percutaneous Thermal Ablation of HCC

NCT ID: NCT05202184

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 213 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2020-12-30

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.

Conditions

HCC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Percutaneous thermal ablation of small HCC

Percutaneous thermal ablation of small HCC

Percutaneous thermal ablation

Intervention Type: PROCEDURE

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

Interventions

Percutaneous thermal ablation

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BORIS GUIU, PU-PH

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Uhmontpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL17_0436_3

Identifier Type: -

Identifier Source: org_study_id