Radiology, InterventionalNCT05495529
Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors
An observational study of Radiology, Interventional and Liver Neoplasm, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
This study aims to analyse retrospectively the feasibility, the safety, and the efficiency, of biliary or digestive protection with room air interposition for thermal ablation of central liver tumors with high iatrogenic risk. Thermal ablation is a mini-invasive and curative treatement of liver tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiology, Interventional, Liver Neoplasm, Carcinoma, Hepatocellular (RENI)
- What is being tested?
- Thermal Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2013to 11 May 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with single malignant liver tumor with high iatrogenic risk treated by thermal ablation with biliary or digestive protection by room air interposition, in Nice CHU, between January 2013 and December 2021.
Who may be able to join
- Patients with single malignant primary or secondary liver tumor
- Thermal ablation area located within 1 centimeter from central biliary tree or gut
- Thermal insulation using room air interposition
- Follow-up of at least 2 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors With High Iatrogenic Risk
This study aims to analyse retrospectively the feasibility, the safety, and the efficiency, of biliary or digestive protection with room air interposition for thermal ablation of central liver tumors with high iatrogenic risk.
Thermal ablation is a mini-invasive and curative treatement of liver tumors. However, it requires to be carefull about surrunding organs, such as digestive structures or central biliary tree, which can be injured if not insulated.
Read more
The technique of gas interposition to protect adjacent gut is already known and validated with carbonic gas. Nevertheless, resorption of this gas is very fast, making its use tricky to keep a correct insulation during the whole thermal ablation process.
Room air interposition is easy to use and can offer a slow resorption speed. Furthermore no datas are available concerning the use of room air whatever the organ protected, and the protection of central biliary tree whatever the gas used.
- Conditions
- Radiology, Interventional, Liver Neoplasm, Carcinoma, Hepatocellular (RENI), Neoplasm Metastasis, Ablation Techniques, Radiofrequency Ablation
- Being tested
- Thermal Ablation
- Medical subject headings
- Liver Neoplasms, Carcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal AblationProcedure or surgery
Data collection about complications, succes of the procedure, succes of complete treatement, recurrence, biologic pertubations.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with single liver tumor traited by thermoablation with high iatrogenic risk, with biliary or digestive protection by ambiant air interposition Receives: Procedure: Thermal Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability
Technical succes of the procedure = feasibility of insulation with room air
Measured: 1 day
Security
Complications (intraoperative clinical or radiological event/abnormality, biological perturbation, clinical event in hospitalization report, imaging request), classified according to SIR (Society of Interventional Radiology) classification in two classes: minor (no additional therapy needed) and major (specific therapy needed) complications.
Measured: 2 months
Efficacity
Response in imaging (MRI or CT) for the tumor treated with thermal ablation
Measured: 2 months
Clinical success
Overall survival
Measured: 2 months
Secondary outcomes (3)
Local and distant recurrence
- Local recurrence: defined by MRI or CT recurrence within 10 mm from thermal ablation area
- Distant recurrence:
- Hepatic: defined by MRI or CT intra-hepatic recurrence which is not defined as local recurrence II. Extrahepatic: defined by MRI or CT extra-hepatic recurrence
Measured: 2 months
Local tumorous recurrence free survival
Local tumorous recurrence free survival analysis
Measured: 2 months
Progression free survival
Local or distant recurrence free survival analysis
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Jan 2013
- Primary completion31 Dec 2021
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiology, InterventionalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GARGIULO Manuel, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495529
- Sponsor's protocol ID
- 22Imagerie01
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors With High Iatrogenic Risk
- ClinicalTrials.gov ID
- NCT05495529
- Acronym / sponsor ID
- 22Imagerie01
- Conditions
- Radiology, Interventional, Liver Neoplasm, Carcinoma, Hepatocellular (RENI), Neoplasm Metastasis, Ablation Techniques, Radiofrequency Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 10 Aug 2022 (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.
This study aims to analyse retrospectively the feasibility, the safety, and the efficiency, of biliary or digestive protection with room air interposition for thermal ablation of central liver tumors with high iatrogenic risk.
Thermal ablation is a mini-invasive and curative treatement of liver tumors. However, it requires to be carefull about surrunding organs, such as digestive structures or central biliary tree, which can be injured if not insulated.
The technique of gas interposition to protect adjacent gut is already known and validated with carbonic gas. Nevertheless, resorption of this gas is very fast, making its use tricky to keep a correct insulation during the whole thermal ablation process.
Room air interposition is easy to use and can offer a slow resorption speed. Furthermore no datas are available concerning the use of room air whatever the organ protected, and the protection of central biliary tree whatever the gas used.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Thermal AblationPatients with single liver tumor traited by thermoablation with high iatrogenic risk, with biliary or digestive protection by ambiant air interposition |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with single malignant liver tumor with high iatrogenic risk treated by thermal ablation with biliary or digestive protection by room air interposition, in Nice CHU, between January 2013 and December 2021.
Key inclusion criteria (4 listed)
- Patients with single malignant primary or secondary liver tumor
- Thermal ablation area located within 1 centimeter from central biliary tree or gut
- Thermal insulation using room air interposition
- Follow-up of at least 2 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Thermal AblationData collection about complications, succes of the procedure, succes of complete treatement, recurrence, biologic pertubations. | Procedure or surgery | Patients |
Primary outcome
Feasability
Time frame: 1 day
Technical succes of the procedure = feasibility of insulation with room air
Security
Time frame: 2 months
Complications (intraoperative clinical or radiological event/abnormality, biological perturbation, clinical event in hospitalization report, imaging request), classified according to SIR (Society of Interventional Radiology) classification in two classes: minor (no additional therapy needed) and major (specific therapy needed) complications.
Efficacity
Time frame: 2 months
Response in imaging (MRI or CT) for the tumor treated with thermal ablation
Clinical success
Time frame: 2 months
Overall survival
3 secondary outcomes
Local and distant recurrence
Time frame: 2 months
Local tumorous recurrence free survival
Time frame: 2 months
Progression free survival
Time frame: 2 months
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 10 Aug 2022.
- Individual participant dataSharing planned: No
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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.
GARGIULO Manuel principal investigator
Centre Hospitalier Universitaire de Nice
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 Radiology, Interventional and Liver Neoplasm, run by Centre Hospitalier Universitaire de Nice 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 4 inclusion and 0 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 10 Aug 2022. 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?
Feasability (time frame: 1 day). The study lists 4 primary outcomes in all. 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 10 Aug 2022.