NCT05202184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

5.9 years

First QC Date

January 7, 2022

Last Update Submit

January 24, 2022

Conditions

Keywords

With or without cirrhosisBCLC0 or ANo extra-hepatic diseaseRadiofrequency ablationMicrowave ablationLiver transplantation

Outcome Measures

Primary Outcomes (1)

  • Incidence of non transplantable recurrence

    Incidence of non transplantable recurrence

    1 day

Study Arms (1)

Percutaneous thermal ablation of small HCC

Percutaneous thermal ablation of small HCC

Procedure: Percutaneous thermal ablation

Interventions

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

Percutaneous thermal ablation of small HCC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • \- age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

  • BORIS GUIU, PU-PH

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 21, 2022

Study Start

January 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 30, 2020

Last Updated

February 8, 2022

Record last verified: 2022-01

Locations