Evaluation of the Reproducibility of Ablation Volumes at One Month After Microwave Treatment Compared to the Manufacturer's Abacus: on the Kidney, Liver and Lung

NCT04072224 | Completed

• 1 other identifier: Local/2018/02
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Microwave thermal ablation (MO) is recognized as an alternative to surgery for the local-regional treatment of primary and secondary hepatic and renal tumors and for secondary pulmonary tumors in patients at anesthetic and/or surgical risk. Microwaves have a reputation for not producing reproducible ablation volumes with elliptical deformations and risks of over or under processing. The Covidien manufacturer offers a microwave system that guarantees more spherical and reproducible ablations: Emprint TM ablation system with Thermosphere TM technology (thermal control, field control, wavelength control). The investigators have 2 years of experience and therefore propose to carry out a first retrospective study, on a cohort of about fifty patients, whose objective will be to compare the volume of in vivo ablation one month after thermo-ablative treatment by microwave of a hepatic, renal or pulmonary tumour with the reference volume announced by the Covidien abacus manufacturer. Microwave ablation, which is much less studied, is less used because of the low reproducibility of necrosis volumes. The Covidien manufacturer offers a system that allows ablation volumes that are supposed to be reproducible, which attracted the Nîmes University Hospital during the call for tenders. To the investigator's knowledge, there are no studies that have evaluated the actual volume of ablation by this system.

Conditions

Hepatic Tumor; Renal Tumor

Outcome Measures

Primary Outcomes (1)

• Description of volume of in vivo ablation

  microwave ablation Versus ablation by the Covidien abacus manufacturer

  at one month

Secondary Outcomes (2)

• spleen response

  at one month

• liver response

  at one month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major patients who have received thermoablative treatment with MO with the Covidian manufacturer of a primary hepatic or renal tumor or secondary hepatic, renal or pulmonary tumor

You may qualify if:

• thermo-ablative treated patients with MO with the Covidian manufacturer
• primary hepatic or renal or secondary hepatic, renal or pulmonary tumor at the University Hospital of Nîmes between June 2016 and June 2018
• diagnosis and size of the tumour established on the basis of tomodensitometric (CT) or magnetic resonance (MRI) imaging.

You may not qualify if:

• patients with coagulation disorders
• patients with progressive infectious process contraindicating the procedure and/or for whom thermo-ablation equipment other than Covidien has been used

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: August 28, 2019
• Study Start: October 23, 2018
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

FR (1)