Small and Steatotic Hepatocellular Carcinoma

NCT ID: NCT03428321

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

238 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2019-12-30

Brief Summary

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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

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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

Conditions

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HCC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BORIS GUIU, PU-PH

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL17_0436

Identifier Type: -

Identifier Source: org_study_id

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