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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with single liver tumor traited by thermoablation with high iatrogenic risk, with biliary or digestive protection by ambiant air interposition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal Ablation | Procedure | Data collection about complications, succes of the procedure, succes of complete treatement, recurrence, biologic pertubations. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Local and 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 |
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Inclusion Criteria :
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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.
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| Name | Affiliation | Role |
|---|---|---|
| GARGIULO Manuel | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice | Nice | France |
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| 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 |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D002277 | Carcinoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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