HCCNCT03428321
Small and Steatotic Hepatocellular Carcinoma
An observational study of HCC, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Percutaneous thermoablation in an effective local curative treatment in patients with cirrhosis and HCC smaller than 3 cm in diameter (BCLC 0-A). Around 30% of HCC patients referred for percutaneous ablation were regarded as non-feasible because of a difficult-at risk location or undetectable nodules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC
- How many people
- 238 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to 30 Dec 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent one or several percutaneous thermoablations for HCC form January 2015 to November 2019 at the Department of Radiology St-Eloi University Hospital - Montpellier School of Medicine France.
Who may be able to join
- HCC according to histological examination or Barcelona criteria
- BCLC0 or A
- Measurable targets according to mRECIST v1.1
- Child A or B7 cirrhosis
- HCC < 4 cm, < 3 nodules, Age ≥ 18 years
- No extrahepatic metastasis, no vascular invasion
- Performance status 0 or 1
- Thrombocytes ≥ 50 000/mm3, TP > 50%
Who cannot join
- Follow-up < 1month
- Lobar/main portal venous thrombus
- Abundant ascites
- Antecedent of bilio-digestive anastomosis or endoscopic sphincterotomy
- Combined treatment with embolization or chemo-embolization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Small and Steatotic Hepatocellular Carcinoma : a Distinctive Radiological Variant With Improved Outcome After Percutenous Ablation
Percutaneous thermoablation in an effective local curative treatment in patients with cirrhosis and HCC smaller than 3 cm in diameter (BCLC 0-A).
Around 30% of HCC patients referred for percutaneous ablation were regarded as non-feasible because of a difficult-at risk location or undetectable nodules.
Read more
We used percutaneous thermoablation to treat HCC on high risk locations (subcapsular or liver dome) with or without lipiodol marked (for undetectable HCC).
No clinical study has been published so far to compare percutaneous thermoablation of HCC on liver dome CT guided with artificial pneumothorax and lipiodol marked, and percutaneous thermoablation of HCC guided by ultrasonography (non subcapsular, distent form diaphragm).
This retrospective study evaluate the overall survival, the local tumor progression or distant liver progression after percutaneous ablation for HCC and determine prognostic factors.
Read the detailed description
We performed 412 percutaneous thermoablations on 238 patients for HCC between January 2015 and November 2019.
All thermoablation procedures were performed percutaneously under ultrasound or CT guidance, with ou without artificial pneumothorax or ascites, with ou without lipiodol marked.
Purposes:
- Tumor response upon mRECIST criteria
- Progression-free survival
- Overall survival
- Local tumor progression
- Distent liver progression
- Prognostic factors
- Conditions
- HCC
- Keywords
- Microwave ablation, Percutaneous thermalablation, High risk location, Articifial pneumothorax, Lipiodol marked, Prognostic factor
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal ablations
Evaluation of thermal ablations (radiofrequency and microwave ablation)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Jan 2015
- Primary completion1 Nov 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BORIS GUIU, PU-PH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428321
- Sponsor's protocol ID
- RECHMPL17_0436
- Status last verified
- May 2020
- First submitted
- 8 Jan 2018
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small and Steatotic Hepatocellular Carcinoma : a Distinctive Radiological Variant With Improved Outcome After Percutenous Ablation
- ClinicalTrials.gov ID
- NCT03428321
- Acronym / sponsor ID
- RECHMPL17_0436
- Conditions
- HCC
- Keywords
- Microwave ablation, Percutaneous thermalablation, High risk location, Articifial pneumothorax, Lipiodol marked, Prognostic factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 9 Feb 2018 (actual)
- 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.
Percutaneous thermoablation in an effective local curative treatment in patients with cirrhosis and HCC smaller than 3 cm in diameter (BCLC 0-A).
Around 30% of HCC patients referred for percutaneous ablation were regarded as non-feasible because of a difficult-at risk location or undetectable nodules.
We used percutaneous thermoablation to treat HCC on high risk locations (subcapsular or liver dome) with or without lipiodol marked (for undetectable HCC).
No clinical study has been published so far to compare percutaneous thermoablation of HCC on liver dome CT guided with artificial pneumothorax and lipiodol marked, and percutaneous thermoablation of HCC guided by ultrasonography (non subcapsular, distent form diaphragm).
This retrospective study evaluate the overall survival, the local tumor progression or distant liver progression after percutaneous ablation for HCC and determine prognostic factors.
Detailed description
We performed 412 percutaneous thermoablations on 238 patients for HCC between January 2015 and November 2019.
All thermoablation procedures were performed percutaneously under ultrasound or CT guidance, with ou without artificial pneumothorax or ascites, with ou without lipiodol marked.
Purposes:
- Tumor response upon mRECIST criteria
- Progression-free survival
- Overall survival
- Local tumor progression
- Distent liver progression
- Prognostic factors
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent one or several percutaneous thermoablations for HCC form January 2015 to November 2019 at the Department of Radiology St-Eloi University Hospital - Montpellier School of Medicine France.
Key inclusion criteria (8 listed)
- HCC according to histological examination or Barcelona criteria
- BCLC0 or A
- Measurable targets according to mRECIST v1.1
- Child A or B7 cirrhosis
- HCC < 4 cm, < 3 nodules, Age ≥ 18 years
Key exclusion criteria (5 listed)
- Follow-up < 1month
- Lobar/main portal venous thrombus
- Abundant ascites
- Antecedent of bilio-digestive anastomosis or endoscopic sphincterotomy
- Combined treatment with embolization or chemo-embolization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thermal ablations
Time frame: 1 day
Evaluation of thermal ablations (radiofrequency and microwave ablation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
BORIS GUIU, PU-PH study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC, run by University Hospital, Montpellier at 1 site in France.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 6 May 2020. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal ablations (time frame: 1 day). 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 6 May 2020.