Small and Steatotic Hepatocellular Carcinoma

May 4, 2020 updated by: University Hospital, Montpellier

Small and Steatotic Hepatocellular Carcinoma : a Distinctive Radiological Variant With Improved Outcome After Percutenous Ablation

Percutaneous thermoablation in an effective local curative treatment in patients with cirrhosis and HCC smaller than 3 cm in diameter (BCLC 0-A).

Around 30% of HCC patients referred for percutaneous ablation were regarded as non-feasible because of a difficult-at risk location or undetectable nodules.

We used percutaneous thermoablation to treat HCC on high risk locations (subcapsular or liver dome) with or without lipiodol marked (for undetectable HCC).

No clinical study has been published so far to compare percutaneous thermoablation of HCC on liver dome CT guided with artificial pneumothorax and lipiodol marked, and percutaneous thermoablation of HCC guided by ultrasonography (non subcapsular, distent form diaphragm).

This retrospective study evaluate the overall survival, the local tumor progression or distant liver progression after percutaneous ablation for HCC and determine prognostic factors.

Study Overview

Status

Completed

Conditions

Detailed Description

We performed 412 percutaneous thermoablations on 238 patients for HCC between January 2015 and November 2019.

All thermoablation procedures were performed percutaneously under ultrasound or CT guidance, with ou without artificial pneumothorax or ascites, with ou without lipiodol marked.

Purposes:

  • Tumor response upon mRECIST criteria
  • Progression-free survival
  • Overall survival
  • Local tumor progression
  • Distent liver progression
  • Prognostic factors

Study Type

Observational

Enrollment (Actual)

238

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who underwent one or several percutaneous thermoablations for HCC form January 2015 to November 2019 at the Department of Radiology St-Eloi University Hospital - Montpellier School of Medicine France.

Description

Inclusion criteria:

  • HCC according to histological examination or Barcelona criteria
  • BCLC0 or A
  • Measurable targets according to mRECIST v1.1
  • Child A or B7 cirrhosis
  • HCC < 4 cm, < 3 nodules, Age ≥ 18 years
  • No extrahepatic metastasis, no vascular invasion
  • Performance status 0 or 1
  • Thrombocytes ≥ 50 000/mm3, TP > 50%

Exclusion criteria:

  • Follow-up < 1month
  • Lobar/main portal venous thrombus
  • Abundant ascites
  • Antecedent of bilio-digestive anastomosis or endoscopic sphincterotomy
  • Combined treatment with embolization or chemo-embolization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thermal ablations
Time Frame: 1 day
Evaluation of thermal ablations (radiofrequency and microwave ablation)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: BORIS GUIU, PU-PH, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL17_0436

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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