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Trial of Ablation of Small Hepatocellular Carcinomas in Patients of Cirrhosis

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ClinicalTrials.gov Identifier: NCT01438437
Recruitment Status : Unknown
Verified July 2012 by Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Recruiting
First Posted : September 22, 2011
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: PAI Procedure: RFA Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2001
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Local tumor response [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Survival rate [ Time Frame: 2 years ]
  2. Number of patients with complications [ Time Frame: 2 years ]
    Number of patients developing any complications during and after procedure will be noted.

  3. 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




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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by Subrat Kumar Acharya, 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
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents