Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

NCT03395379 | Completed

• 1 other identifier: URO-BASE01
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Unrecognized Condition

Keywords

Radiofrequency; Thermal Protection; Percutaneous thermal ablation; Kidney neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-operative complications

  6 weeks post-operative

Study Arms (2)

Group 1

RFA without air dissection protection

Procedure: RFA

Group 2

RFA with air dissection protection

Procedure: RFA

Interventions

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.

Group 1; Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Related Publications (9)

• 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.

  PMID: 10869624 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.

  PMID: 17116555 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.

  PMID: 16304025 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.

  PMID: 21993321 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.

  PMID: 25962750 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.

  PMID: 19933665 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.

  PMID: 16632684 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.

  PMID: 14573426 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.

  PMID: 9376843 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; 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: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 10, 2018
• Study Start: January 11, 2012
• Primary Completion: March 15, 2016
• Study Completion: May 15, 2016
• Last Updated: January 10, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share