Small and Steatotic Hepatocellular Carcinoma

HCC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428321
• Other study ID #: RECHMPL17_0436
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: December 30, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HCC

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thermal ablations	Evaluation of thermal ablations (radiofrequency and microwave ablation)	1 day