Hepatocellular CarcinomaPhase 4NCT01438437
Trial of Ablation of Small Hepatocellular Carcinomas in Patients of Cirrhosis
A Phase 4 study testing PAI and RFA in people with Hepatocellular Carcinoma, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- PAI and RFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2001to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
AIIMS
New Delhi, National Capital Territory of Delhi, 110029
Subrat K Acharya, DM, 911126594934, subratacharya2004@yahoo.com
About this study
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.
Read the 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
- Two imaging modalities (dual phase CT (DPCT)/ contrast enhanced Magnetic Resonance Imaging (MRI)) showing arterialization of the hepatic mass
- AFP more than 400ng/ml along with arterialisation on one imaging modality (DPCT/ contrast enhanced MRI)
- Fine needle aspiration cytology (FNAC)
Definitions
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- PAI, RFA
- Keywords
- Hepatocellular carcinoma, Radiofrequency ablation, Percutaneous acetic acid ablation, Tumour response
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAIProcedure or surgery
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
RFAProcedure or surgery
Under aseptic conditions and local anesthesia, the needle electrode would be introduced percutaneously into the tumor under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous acetic acid | Active comparator | Not described Receives: Procedure: PAI |
| Radiofrequency ablation | Active comparator | Not described Receives: Procedure: RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor response
Measured: 2 years
Secondary outcomes (3)
Survival rate
Measured: 2 years
Number of patients with complications
Number of patients developing any complications during and after procedure will be noted.
Measured: 2 years
Change from baseline in Child status at 1 year
Child status is calculated from the following 5 parameters
- Bilirubin < 2: 1, 2-3: 2 and > 3 : 3 points
- Albumin: > 3.5: 1, 2.8-3.5 : 2 and <2.8: 3 points
- Prothrombin time( seconds over control): 1-3: 1, 4-6: 2 and > 6: 3
- Encephalopathy: None: 1, (grade 1 and 2): 2 and (grade 3 and 4): 3
- Ascites: Absent: 1, slight: 2 and moderate: 3
Child A: score 5-6, Child B: 7-9 and Child C: 10 or more
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startMar 2001
- Primary completionAug 2014 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subrat Kumar Acharya, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438437
- Sponsor's protocol ID
- 23-16/11/2001
- Status last verified
- Jul 2012
- First submitted
- 14 Sep 2011
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Ablation of Small Hepatocellular Carcinomas in Patients of Cirrhosis
- ClinicalTrials.gov ID
- NCT01438437
- Acronym / sponsor ID
- 23-16/11/2001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Radiofrequency ablation, Percutaneous acetic acid ablation, Tumour response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2001
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 22 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Two imaging modalities (dual phase CT (DPCT)/ contrast enhanced Magnetic Resonance Imaging (MRI)) showing arterialization of the hepatic mass
- AFP more than 400ng/ml along with arterialisation on one imaging modality (DPCT/ contrast enhanced MRI)
- Fine needle aspiration cytology (FNAC)
Definitions
- 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.
- 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.
- 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.
- 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
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous acetic acid | Active comparator | Procedure: PAI |
| Radiofrequency ablation | Active comparator | Procedure: RFA |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAIUnder 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 | Procedure or surgery | Percutaneous acetic acid |
| RFAUnder aseptic conditions and local anesthesia, the needle electrode would be introduced percutaneously into the tumor under ultrasound guidance. | Procedure or surgery | Radiofrequency ablation |
Primary outcome
Local tumor response
Time frame: 2 years
3 secondary outcomes
Survival rate
Time frame: 2 years
Number of patients with complications
Time frame: 2 years
Change from baseline in Child status at 1 year
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PAI and RFA in people with Hepatocellular Carcinoma, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Subrat K Acharya, DM (01126594934, subratacharya2004@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor response (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012.