To assess the efficacy of Radiofrequency Ablation (RFA) and Percutaneous acetic acid (PAI)for the management of small hepatocellular carcinoma (HCC) in patients of cirrhosis of liver and whether PAI is equally effective as RFA.
Phase 3
- Registration Number
- CTRI/2008/091/000061
- Lead Sponsor
- Subrat Acharya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 74
Inclusion Criteria
•Childâ??s A or B cirrhosis with liver mass.
•Number of liver masses not more than 5 and the size of each <5cm in diameter.
•No extrahepatic disease.
•Absence of malignant portal vein thrombosis.
•Platelet count more than 70,000/mm3
•Prothrombin time more than 50%.
•Written consent of patient.
Exclusion Criteria
•Childsâ??C cirrhosis with liver mass.
•Liver mass >5cm in diameter.
•Number of liver masses more than 5.
•Peripherally located masses with no hepatic parenchyma around
•Liver mass not discernable on ultrasound.
•Extra hepatic disease like RP adenopathy, distant metastasis.
•Coagulation disorders.
•Unwilling patient
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary OutcomeTimepoint: a) Local recurrence<br>When the Triple phase CT shows-<br>â?¢ An area of nodular enhancement seen within or at the periphery of the ablative defect. <br>â?¢ Recurrent soft tissue causing distortion of the otherwise smooth interphase with the adjoining liver parenchyma.<br> <br>b) Fresh lesion- When a new lesion is seen in the liver at a site other than the primary site of the treated lesion with normal liver parenchyma intervening in between , will be considered as a fresh lesion.<br><br>c) Complications- Post procedural complications will be noted within 24 hours, 24 hours to 1 week and more than a week.<br>
- Secondary Outcome Measures
Name Time Method Secondary Outcome<br>Timepoint: a) Survival rate- The survival rate will be estimated at one and two years post ablation.<br><br>b)Childsâ?? status of cirrhosis- will be ascertained at one and two years of follow up depending upon the Childsâ?? score- <br>Score <6- Childsâ??A, >6 - <9 Childsâ??B and >9 Childsâ??C<br>