Status:
TERMINATED
Major RF Ablations of Hepatomas Under MR Thermometry Monitoring
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hepatocellular Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Object of the study: To assess the effectiveness of MR temperature monitoring of RFA of large hepatocellular carcinomas (HCC) (≥ 5 cm) in terms of complete tumor necrosis rate achieved and in term of...
Detailed Description
The RF procedure and results assessment: 1. In preparing MR room, the patient will be positioned on MR bed put on dedicated MR compatible trolley. The abdominal antenna will be installed. 2. General ...
Eligibility Criteria
Inclusion
- Patient of 18 year old.
- Up to 3 tumors unresectable suspected to be HCC according the criteria as previously defined by EASL and recently revised by AASLD among them at least one having a maximal diameter equal or larger than 5 cm.
- Proof of underlying cirrhosis.
- Multidisciplinary decision of RF ablation treatment
- Informed consent of patient
- Available healthcare insurance
Exclusion
- Patient with short term life training uncontrollable disease
- Pregnancy
- Follow up Impossible
- Contra indication for general anesthesia
- Contra indication for MR examination with gadolinium injection
- Tumor located at less than 10 mm from colonic wall or main biliary tract
- Tumor invisible on MR examination
- Absence of safe percutaneous course to puncture the tumor
- Child - Pugh B or C cirrhosis
- Abundant ascites
- PROTHROMBIN activity \< 50 %
- Platelet count \< 40 .10 3/ml
- Antecedent of ascitis decompensation
- Severe portal hypertension defined by the presence of large oesophageal variceal (grade 2) , of radiological ascitis or umbilical vein repermeabilisation
- Elevation of transaminases (\>3 upper limit normal range)
- Antecedent of biliodigestive anastomosis
- Antecedent of endoscopic sphincterotomy
Key Trial Info
Start Date :
June 20 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01486134
Start Date
June 20 2012
End Date
December 20 2016
Last Update
May 13 2020
Active Locations (1)
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1
CHU Jean VERDIER
Bondy, France, 93140