Trial of Ablation of Small Hepatocellular Carcinomas in Patients of Cirrhosis

July 12, 2012 updated by: Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi
The purpose of this study is to assess the efficacy of Radiofrequency ablation (RFA) and percutaneous acetic acid ablation (PAI) in the management of small hepatocellular carcinoma (HCC) in patients of cirrhosis of liver.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Setting The study would be conducted at the All India Institute of Medical Sciences, New Delhi, a tertiary care teaching hospital, in the departments of Gastroenetrology and Radiodiagnosis.

Sample size Taking RFA as a standard procedure with an estimated success rate of 95%, a sample size of minimum 27 for each arm is required to detect an equivalence difference of 10%, assuming that PAI has a success rate of 85%. This sample size is expected to provide a power of 80%.

Randomization

  • Stratified randomization of Child A and B will be done.
  • Randomization into A (Acetic acid) and B (Radiofrequency ablation) will be done.

Diagnostic criteria

  • Cirrhosis of liver- Diagnosis will be founded on the basis of clinical, biochemical, imaging and endoscopy findings.

Hepatocellular carcinoma- when any one of the following is present

  1. Two imaging modalities (dual phase CT (DPCT)/ contrast enhanced Magnetic Resonance Imaging (MRI)) showing arterialization of the hepatic mass
  2. AFP more than 400ng/ml along with arterialisation on one imaging modality (DPCT/ contrast enhanced MRI)
  3. Fine needle aspiration cytology (FNAC)

Definitions

  1. Local recurrence : When the Triple phase CT shows-

    • An area of nodular enhancement that abuts or surrounds the ablation defect or protrudes into the low attenuating necrotic tissue (may sometimes be seen only on arterial phase of CT)
    • Recurrent soft tissue causing distortion of the otherwise smooth interphase with the adjoining liver parenchyma.
  2. 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.

  3. Residual disease or incomplete ablation When the follow up Triple phase CT shows-

    • Residual nodular enhancement that abuts or surrounds the low attenuating ablation defect or protrudes into the low attenuating necrotic tissue (may sometimes be seen only on arterial phase of CT)
    • Residual soft tissue causing distortion of the otherwise smooth interphase with the adjoining liver parenchyma.
    • Concenteric hyperemia around the low attenuating defect showing area of focal nodularity or asymmetric thickness.

  4. End point of ablation When the Triple phase CT shows-

    • A homogenous, well defined, uniformly low attenuating defect larger than the pretreatment size.
    • No residual soft tissue seen within or at the periphery of the low attenuating defect
    • Concentric hyperemia around the low attenuating defect of uniform thickness with no focal nodularity.

Follow up

  1. Clinical follow up

    • All patients would be followed up in the Liver clinic monthly unless their clinical condition warrants earlier follow up
    • Liver function tests/ complete blood count would also be done at each visit and Alfafetoprotein (AFP) every six months
    • Patient tolerance, child's status would be estimated.

  2. Imaging follow up

    • At one month, a dual phase CT would be done to ascertain the local response to therapy and the need to repeat the procedure. After achieving the end point after ablation (PAI and RFA, the DPCT would be done at 3 and 6 monthly intervals.

Duration of follow up - Since more than 80% recurrence occurs in 2 years therefore the duration of follow up would be 2 years after ablation.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 66 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child'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:

  • Childs'C cirrhosis with liver mass.
  • Liver mass >5cm in diameter.
  • Number of liver masses more than 3
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Percutaneous acetic acid
Procedure: PAI
Under local anaesthesia, taking proper aseptic precautions, 40% acetic acid (total dose not exceeding 3 times the diameter of the mass, (not more than 2ml in one sitting), will be injected into the mass through the percutaneous route
Active Comparator: Radiofrequency ablation
Procedure: RFA
Under aseptic conditions and local anesthesia, the needle electrode would be introduced percutaneously into the tumor under ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local tumor response
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 2 years
2 years
Number of patients with complications
Time Frame: 2 years
Number of patients developing any complications during and after procedure will be noted.
2 years
Change from baseline in Child status at 1 year
Time Frame: 2 years

Child status is calculated from the following 5 parameters

  1. Bilirubin < 2: 1, 2-3: 2 and > 3 : 3 points
  2. Albumin: > 3.5: 1, 2.8-3.5 : 2 and <2.8: 3 points
  3. Prothrombin time( seconds over control): 1-3: 1, 4-6: 2 and > 6: 3
  4. Encephalopathy: None: 1, (grade 1 and 2): 2 and (grade 3 and 4): 3
  5. Ascites: Absent: 1, slight: 2 and moderate: 3

Child A: score 5-6, Child B: 7-9 and Child C: 10 or more
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 21, 2011

First Posted (Estimate)

September 22, 2011

Study Record Updates

Last Update Posted (Estimate)

July 13, 2012

Last Update Submitted That Met QC Criteria

July 12, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-16/11/2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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