Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

NCT ID: NCT03395379

Last Updated: 2018-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-11

Study Completion Date

2016-05-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Unrecognized Condition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

RFA without air dissection protection

RFA

Intervention Type 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.

Group 2

RFA with air dissection protection

RFA

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 10869624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17116555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16304025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21993321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25962750 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19933665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16632684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14573426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9376843 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4916825/

Thermal protection during percutaneous thermal ablation procedures: interest of carbon dioxide dissection and temperature monitoring.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3834111/

Minimizing diaphragmatic injury during radiofrequency ablation: efficacy of intra-abdominal carbon dioxide insufflation

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2408950/

Thermal protection during percutaneous thermal ablation of renal cell carcinoma.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2443416/

Thermal protection with 5% dextrose solution blanket during radiofrequency ablation.

Other Identifiers

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URO-BASE01

Identifier Type: -

Identifier Source: org_study_id

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