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

NCT ID: NCT05495529

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2022-05-11

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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients

Patients with single liver tumor traited by thermoablation with high iatrogenic risk, with biliary or digestive protection by ambiant air interposition

Thermal Ablation

Intervention Type PROCEDURE

Data collection about complications, succes of the procedure, succes of complete treatement, recurrence, biologic pertubations.

Interventions

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Thermal Ablation

Data collection about complications, succes of the procedure, succes of complete treatement, recurrence, biologic pertubations.

Intervention Type PROCEDURE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GARGIULO Manuel

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice

Nice, , France

Site Status

Countries

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France

Other Identifiers

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22Imagerie01

Identifier Type: -

Identifier Source: org_study_id

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