Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients Patients with single liver tumor traited by thermoablation with high iatrogenic risk, with biliary or digestive protection by ambiant air interposition |
Procedure: Thermal Ablation
Data collection about complications, succes of the procedure, succes of complete treatement, recurrence, biologic pertubations.
|
Outcome Measures
Primary Outcome Measures
- Feasability [1 day]
Technical succes of the procedure = feasibility of insulation with room air
- Security [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 [2 months]
Response in imaging (MRI or CT) for the tumor treated with thermal ablation
- Clinical success [2 months]
Overall survival
Secondary Outcome Measures
- Local and distant recurrence [2 months]
Local recurrence: defined by MRI or CT recurrence within 10 mm from thermal ablation area Distant recurrence: I. 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
- Local tumorous recurrence free survival [2 months]
Local tumorous recurrence free survival analysis
- Progression free survival [2 months]
Local or distant recurrence free survival analysis
Eligibility Criteria
Criteria
Inclusion Criteria :
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Patients with single malignant primary or secondary liver tumor
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Thermal ablation area located within 1 centimeter from central biliary tree or gut
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Thermal insulation using room air interposition
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Follow-up of at least 2 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nice | Nice | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nice
Investigators
- Principal Investigator: GARGIULO Manuel, Centre Hospitalier Universitaire de Nice
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22Imagerie01