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

Neoplasm Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05495529
• Other study ID #: 22Imagerie01
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: May 11, 2022

Study information

• Verified date: August 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 11, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ablation Techniques
• Carcinoma, Hepatocellular
• Liver Neoplasm
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Radiofrequency Ablation

Intervention

Procedure:
• Thermal Ablation
Data collection about complications, succes of the procedure, succes of complete treatement, recurrence, biologic pertubations.

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasability	Technical succes of the procedure = feasibility of insulation with room air	1 day
Primary	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
Primary	Efficacity	Response in imaging (MRI or CT) for the tumor treated with thermal ablation	2 months
Primary	Clinical success	Overall survival	2 months
Secondary	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
Secondary	Local tumorous recurrence free survival	Local tumorous recurrence free survival analysis	2 months
Secondary	Progression free survival	Local or distant recurrence free survival analysis	2 months