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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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The investigators aimed to evaluate the feasibility and safety of using ambient air to protect against thermal injury during RadioFrequency Ablation (RFA) for Renal Cell Carcinoma (RCC) based on data from cases at their institute.
The incidence of renal cell carcinoma (RCC) has been increasing, particularly among patients >65 years of age. As older individuals are at higher risk for surgical complications, the use of radiofrequency ablation (RFA) for small renal masses (SRM) <4 cm in size, which include T1a tumors,may be a compelling treatment option for elderly patients. However, RFA uses heat to destroy abnormal tissue, with the risk of thermal injury to tissues and organs, including gastric tissue and nerve roots, which are in proximity to the targeted treatment zone. The incidence rate of major complication with RFA, including thermal wounds, has been reported to vary between 3.2% and 5.2%. Different thermal protection methods have been developed to lower the risk of injury to adjacent tissues during ablation, such as air dissection using CO2 injection and hydrodissection using G5% for shielding. Although both of these options are effective, they are expensive. To lower the cost of thermal protection, the investigators have been using ambient air instead of CO2 for air dissection prior to RFA for SRM-RCCs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | RFA without air dissection protection |
| |
| Group 2 | RFA with air dissection protection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RFA | Procedure | Radiofrequency ablation (RFA) is a medical procedure in which part of the electrical conduction system of the tumor is ablated using the heat generated from medium frequency alternating current. |
| Measure | Description | Time Frame |
|---|---|---|
| Failure rate of the air dissection procedure | The failure rate of the air dissection procedure is defined as the need for another dissection method, the inability to create sufficient space for successful dissection and/or damage to surrounding vital tissues. | 6 weeks post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative complications | Minor and major complications are recorded, corresponding to Clavien Dindo classification | 6 weeks post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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The study cohort is selected from our institution. Patients with a single SRM of <4 cm, confirmed as RCC on biopsy, are offered RFA as an alternative to open resection. In cases in which vital tissues are located within 10 mm of the target treatment area, air dissection are planned if the patient provide his consent.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10869624 | Background | Luciani LG, Cestari R, Tallarigo C. Incidental renal cell carcinoma-age and stage characterization and clinical implications: study of 1092 patients (1982-1997). Urology. 2000 Jul;56(1):58-62. doi: 10.1016/s0090-4295(00)00534-3. | |
| 17116555 | Background | Turrentine FE, Wang H, Simpson VB, Jones RS. Surgical risk factors, morbidity, and mortality in elderly patients. J Am Coll Surg. 2006 Dec;203(6):865-77. doi: 10.1016/j.jamcollsurg.2006.08.026. |
| Label | URL |
|---|---|
| Recommandations en onco-urologie 2013 du CCAFU: Cancer du rein | View source |
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Submission at several congress: WCE2016, EAU2017, AUA2017 Publication at the Journal of Urology in December 2017
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 16304025 | Background | Boss A, Clasen S, Kuczyk M, Anastasiadis A, Schmidt D, Claussen CD, Schick F, Pereira PL. Thermal damage of the genitofemoral nerve due to radiofrequency ablation of renal cell carcinoma: a potentially avoidable complication. AJR Am J Roentgenol. 2005 Dec;185(6):1627-31. doi: 10.2214/AJR.04.1946. |
| 21993321 | Background | Joniau S, Tsivian M, Gontero P. Radiofrequency ablation for the treatment of small renal masses: safety and oncologic efficacy. Minerva Urol Nefrol. 2011 Sep;63(3):227-36. |
| 25962750 | Background | Pieper CC, Fischer S, Strunk H, Meyer C, Thomas D, Willinek WA, Hauser S, Nadal J, Schild H, Wilhelm K. Percutaneous CT-Guided Radiofrequency Ablation of Solitary Small Renal Masses: A Single Center Experience. Rofo. 2015 Jul;187(7):577-83. doi: 10.1055/s-0034-1399340. Epub 2015 Apr 21. |
| 19933665 | Background | Arellano RS, Garcia RG, Gervais DA, Mueller PR. Percutaneous CT-guided radiofrequency ablation of renal cell carcinoma: efficacy of organ displacement by injection of 5% dextrose in water into the retroperitoneum. AJR Am J Roentgenol. 2009 Dec;193(6):1686-90. doi: 10.2214/AJR.09.2904. |
| 16632684 | Background | Laeseke PF, Sampson LA, Brace CL, Winter TC 3rd, Fine JP, Lee FT Jr. Unintended thermal injuries from radiofrequency ablation: protection with 5% dextrose in water. AJR Am J Roentgenol. 2006 May;186(5 Suppl):S249-54. doi: 10.2214/AJR.04.1240. |
| 14573426 | Background | Farrell MA, Charboneau JW, Callstrom MR, Reading CC, Engen DE, Blute ML. Paranephric water instillation: a technique to prevent bowel injury during percutaneous renal radiofrequency ablation. AJR Am J Roentgenol. 2003 Nov;181(5):1315-7. doi: 10.2214/ajr.181.5.1811315. No abstract available. |
| 9376843 | Background | Zlotta AR, Wildschutz T, Raviv G, Peny MO, van Gansbeke D, Noel JC, Schulman CC. Radiofrequency interstitial tumor ablation (RITA) is a possible new modality for treatment of renal cancer: ex vivo and in vivo experience. J Endourol. 1997 Aug;11(4):251-8. doi: 10.1089/end.1997.11.251. |
| Guidelines on renal cell carcinoma. European Association of Urology | View source |
| Thermal protection during percutaneous thermal ablation procedures: interest of carbon dioxide dissection and temperature monitoring. | View source |
| Minimizing diaphragmatic injury during radiofrequency ablation: efficacy of intra-abdominal carbon dioxide insufflation | View source |
| Thermal protection during percutaneous thermal ablation of renal cell carcinoma. | View source |
| Thermal protection with 5% dextrose solution blanket during radiofrequency ablation. | View source |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |