NCT01438437

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for phase_4 hepatocellular-carcinoma

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_4 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
10.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

13.4 years

First QC Date

September 14, 2011

Last Update Submit

July 12, 2012

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaRadiofrequency ablationPercutaneous acetic acid ablationTumour response

Outcome Measures

Primary Outcomes (1)

  • Local tumor response

    2 years

Secondary Outcomes (3)

  • Survival rate

    2 years

  • Number of patients with complications

    2 years

  • Change from baseline in Child status at 1 year

    2 years

Study Arms (2)

Percutaneous acetic acid

ACTIVE COMPARATOR
Procedure: PAI

Radiofrequency ablation

ACTIVE COMPARATOR
Procedure: RFA

Interventions

PAIPROCEDURE

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

Percutaneous acetic acid
RFAPROCEDURE

Under aseptic conditions and local anesthesia, the needle electrode would be introduced percutaneously into the tumor under ultrasound guidance.

Radiofrequency ablation

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIIMS

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Subrat K Acharya, DM

CONTACT

01126594934subratacharya2004@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor and Head

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 22, 2011

Study Start

March 1, 2001

Primary Completion

August 1, 2014

Study Completion

September 1, 2015

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

IN(1)