Small and Steatotic Hepatocellular Carcinoma

NCT03428321 | Completed

• 1 other identifier: RECHMPL17_0436
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 1

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.

Conditions

HCC

Keywords

Microwave ablation; Percutaneous thermalablation; High risk location; Articifial pneumothorax; Lipiodol marked; Prognostic factor

Outcome Measures

Primary Outcomes (1)

• Thermal ablations

  Evaluation of thermal ablations (radiofrequency and microwave ablation)

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

• BORIS GUIU, PU-PH

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: February 9, 2018
• Study Start: January 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: December 30, 2019
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

FR (1)