Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. This is a retrospective monocentric study that divides patients into three groups according to the organ concerned (liver, kidney, lung). It concerns patients with hepatic, renal or pulmonary tumours whose indication for treatment by thermo-ablation has been validated in RCP at the University Hospital of Nîmes. Each patient was informed of the therapeutic management and was seen in interventional radiology consultation before the expected date of thermo-ablation. A letter of no objection was sent to each patient prior to treatment. A CT or MRI control imaging is performed one month before the operation, systematically at the University Hospital of Nîmes after a thermo-ablative procedure. The size of the ablation volume obtained is measured (major axis and minor axis) on this control imaging. This volume will be compared to the ablation volume planned by the manufacturer, depending on the power and duration of the impact chosen according to the size of the tumor (evaluated on the imaging prior to the procedure). Data stored in Redcap. 50-60 patients included. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04072224
Study type Observational
Source Centre Hospitalier Universitaire de Nimes
Contact
Status Completed
Phase
Start date October 23, 2018
Completion date October 23, 2020

See also
  Status Clinical Trial Phase
Completed NCT03900364 - a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy N/A
Completed NCT02862288 - Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia. Phase 1/Phase 2
Enrolling by invitation NCT05115812 - Renal Autotransplantation; Case Series
Completed NCT04096534 - Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses N/A
Recruiting NCT03747133 - SABR for Renal Tumors N/A
Recruiting NCT04506671 - Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor N/A
Recruiting NCT05377632 - Comparing Two Different Approaches in Robotic-Assisted Renal Surgery N/A
Recruiting NCT03667885 - Non-Invasive Diagnostics of Small Renal Masses
Completed NCT03841149 - Volume 3D_US Kidney
Recruiting NCT05976607 - Clinical Study of 18F -FAPI-RGD in Renal Tumor
Recruiting NCT06322745 - Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy N/A
Terminated NCT02581384 - Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors Phase 1/Phase 2
Completed NCT02335827 - Irreversible Electroporation(IRE) For Unresectable Renal Tumors N/A
Completed NCT05089006 - Cost-effectivness of Robot-assisted Surgery Compared to Open Surgery for Partial Nephrectomy in Context of Renal Tumor
Recruiting NCT03810651 - Pencil Beam Scanning in Patients With Renal Tumors Early Phase 1
Not yet recruiting NCT05572216 - A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99) N/A
Recruiting NCT06076538 - PET/MR for Characterization of Renal Masses (RMs)
Completed NCT01833728 - A Comparison of Nefopam-propacetamol Combination and Propacetamol for Postoperative Quality of Recovery After Laparoscopic Nephrectomy N/A
Recruiting NCT04537247 - A Comparative Study Between Open and Robotic Partial Nephrectomy in Treatment of High Complex Renal Tumors. N/A