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Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT03395379
Recruitment Status : Completed
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.

Condition or disease Intervention/treatment
Unrecognized Condition Procedure: RFA

Detailed 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.

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma
Actual Study Start Date : January 11, 2012
Actual Primary Completion Date : March 15, 2016
Actual Study Completion Date : May 15, 2016


Group/Cohort Intervention/treatment
Group 1
RFA without air dissection protection
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.

Group 2
RFA with air dissection protection
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.




Primary Outcome Measures :
  1. Failure rate of the air dissection procedure [ Time Frame: 6 weeks post-operative ]
    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.


Secondary Outcome Measures :
  1. Post-operative complications [ Time Frame: 6 weeks post-operative ]
    Minor and major complications are recorded, corresponding to Clavien Dindo classification



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Additional Information:
Publications:

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03395379    
Other Study ID Numbers: URO-BASE01
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Submission at several congress: WCE2016, EAU2017, AUA2017 Publication at the Journal of Urology in December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nice:
Radiofrequency
Thermal Protection
Percutaneous thermal ablation
Kidney neoplasms
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases