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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Local tumor response
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2001

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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