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

Completed

• Conditions: Carcinoma, Hepatocellular (RENI); Ablation Techniques; Radiofrequency Ablation; Neoplasm Metastasis; Microwaves; Radiology, Interventional; Liver Neoplasm
• Interventions: Procedure: Thermal Ablation

• Registration Number: NCT05495529
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-05-11
• Status Verified: 2022-08
• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Thermal Ablation	Patients with single liver tumor traited by thermoablation with high iatrogenic risk, with biliary or digestive protection by ambiant air interposition

Primary Outcome Measures

Name	Time	Method
Feasability	1 day	Technical succes of the procedure = feasibility of insulation with room air
Efficacity	2 months	Response in imaging (MRI or CT) for the tumor treated with thermal ablation
Clinical success	2 months	Overall survival
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.

Secondary Outcome Measures

Name	Time	Method
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
Local and distant recurrence	2 months	1. Local recurrence: defined by MRI or CT recurrence within 10 mm from thermal ablation area; 2. 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

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France