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

NCT05495529 | Completed

• 1 other identifier: 22Imagerie01
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Local and distant recurrence

  2 months

• Local tumorous recurrence free survival

  2 months

• Progression free survival

  2 months

Study Arms (1)

Patients

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

Procedure: Thermal Ablation

Interventions

Thermal Ablation PROCEDURE

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

Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma; Neoplasm Metastasis

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• GARGIULO Manuel

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 10, 2022
• Study Start: January 1, 2013
• Primary Completion: December 31, 2021
• Study Completion: May 11, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)