Clinical trial NCT03428321: Small and Steatotic Hepatocellular Carcinoma
Official title: Small and Steatotic Hepatocellular Carcinoma : a Distinctive Radiological Variant With Improved Outcome After Percutenous Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC
Keywords: Microwave ablation
Percutaneous thermalablation
High risk location
Articifial pneumothorax
Lipiodol marked
Prognostic factor
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Thermal ablations
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: BORIS GUIU, PU-PH
role: STUDY_DIRECTOR
References: