Trial of Ablation of Small Hepatocellular Carcinomas in Patients of Cirrhosis

This study is currently recruiting participants.
Verified July 2012 by All India Institute of Medical Sciences, New Delhi
Sponsor:
Information provided by (Responsible Party):
Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01438437
First received: September 14, 2011
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Procedure: PAI
Procedure: RFA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Local tumor response [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of patients with complications [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Number of patients developing any complications during and after procedure will be noted.

  • Change from baseline in Child status at 1 year [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 54
Study Start Date: March 2001
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438437

Contacts
Contact: Subrat K Acharya, DM 01126594934 subratacharya2004@yahoo.com

Locations
India
AIIMS Recruiting
New Delhi, Delhi, India, 110029
Contact: Subrat K Acharya, DM    911126594934    subratacharya2004@yahoo.com   
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Subrat Kumar Acharya, Proffessor and Head, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01438437     History of Changes
Other Study ID Numbers: 23-16/11/2001
Study First Received: September 14, 2011
Last Updated: July 12, 2012
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Hepatocellular carcinoma
Radiofrequency ablation
Percutaneous acetic acid ablation
Tumour response

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Retinol acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014