Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

Unrecognized Condition Clinical Trial

Official title:

Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395379
• Other study ID #: URO-BASE01
• Status: Completed
• Phase: N/A
• First received: January 4, 2018
• Last updated: January 9, 2018
• Start date: January 11, 2012
• Est. completion date: May 15, 2016

Study information

• Verified date: December 2017
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 15, 2016
• Est. primary completion date: March 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with Renal Cell Carcinoma (RCC)

• Patients with a single SRM of <4 cm, confirmed as RCC on biopsy

• RCC status : pT1a

• Eligible patients for an RadioFrequency Ablation (RFA) treatment

Exclusion Criteria:

• Patients who have already received a RFA treatment for an other tissu or tumor

• Patients who have a bleeding tumor or prior local treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Unrecognized Condition

Intervention

Procedure:
• RFA
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	Institut National de la Santé Et de la Recherche Médicale, France

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Post-operative complications	Minor and major complications are recorded, corresponding to Clavien Dindo classification	6 weeks post-operative

External Links

•   Minimizing diaphragmatic injury during radiofrequency ablation: efficacy of intra-abdominal carbon dioxide insufflation
•   Recommandations en onco-urologie 2013 du CCAFU: Cancer du rein
•   Thermal protection during percutaneous thermal ablation of renal cell carcinoma.
•   Thermal protection during percutaneous thermal ablation procedures: interest of carbon dioxide dissection and temperature monitoring.
•   Thermal protection with 5% dextrose solution blanket during radiofrequency ablation.