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OpenTrials
Completed

NCT Number: NCT03428321

Small and Steatotic Hepatocellular Carcinoma

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.

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Key information

Conditions

HCC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Thermal ablations

    Time frame: 1 day

    Evaluation of thermal ablations (radiofrequency and microwave ablation)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 9, 2018
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.