Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors

Study Overview
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Brief Summary
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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.

Official Title
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Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors With High Iatrogenic Risk

Conditions
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Microwaves, Radiology, Interventional, Liver Neoplasm, Carcinoma, Hepatocellular (RENI), Neoplasm Metastasis, Ablation Techniques, Radiofrequency Ablation

Intervention / Treatment
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* Procedure: Thermal Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with single liver tumor traited by thermoablation with high iatrogenic risk, with biliary or digestive protection by ambiant air interposition | Procedure: Thermal Ablation<br>* Data collection about complications, succes of the procedure, succes of complete treatement, recurrence, biologic pertubations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasability | Technical succes of the procedure = feasibility of insulation with room air | 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. | 2 months | 
| Efficacity | Response in imaging (MRI or CT) for the tumor treated with thermal ablation | 2 months | 
| Clinical success | Overall survival | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and distant recurrence | 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 | 2 months | 
| Local tumorous recurrence free survival | Local tumorous recurrence free survival analysis | 2 months | 
| Progression free survival | Local or distant recurrence free survival analysis | 2 months |