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.

Randomized control trial (RCT) of Radiofrequency Ablation (RFA) and Percutaneous acetic acid (PAI) for the Treatment of Hepatocellular Carcinoma in Patients of Cirrhosis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000061

Enrollment

Registered

2008-07-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Ablation by Acetic acid: Not Applicable Control Intervention1: Ablation by radio frequency: Not Applicable

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary OutcomeTimepoint: a) Local recurrence When the Triple phase CT shows- â?¢ An area of nodular enhancement seen within or at the periphery of the ablative defect. â?¢ Recurrent soft tissue causing distortion of the otherwise smooth interphase with the adjoining liver parenchyma. 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. c) Complications- Post procedural complications will be noted within 24 hours, 24 hours to 1 week and more than a week.	—

Measure

Time frame

Primary OutcomeTimepoint: a) Local recurrence When the Triple phase CT shows- â?¢ An area of nodular enhancement seen within or at the periphery of the ablative defect. â?¢ Recurrent soft tissue causing distortion of the otherwise smooth interphase with the adjoining liver parenchyma. 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. c) Complications- Post procedural complications will be noted within 24 hours, 24 hours to 1 week and more than a week.

—

Secondary

Measure	Time frame
Secondary Outcome Timepoint: a) Survival rate- The survival rate will be estimated at one and two years post ablation. b) Childsâ?? status of cirrhosis- will be ascertained at one and two years of follow up depending upon the Childsâ?? score- Score <6- Childsâ??A, >6 - <9 Childsâ??B and >9 Childsâ??C	—

Countries

India

Contacts

Public ContactSubrat Acharya

AIIMS

subratacharya2004@yahoo.com011-26594934

Outcome results