Evaluation of the Efficacy of Radiofrequency in the Treatment of Renal Tumors

Evaluation of the Efficacy of Radiofrequency Ablation in the Treatment of Renal Tumors: Prospective Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02850809

Acronym

RF-REIN

Enrollment

310

Registered

2016-08-01

Start date

2010-10-31

Completion date

2015-12-31

Last updated

2023-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

radiofrequency ablation, complications

Brief summary

Multi-institutional registry on a cohort of 310 patients with biopsy-proven renal cell carcinoma treated by Radiofrequency ablation. All patients will be included consecutively and retrospectively in all centers to obtain the required number of patient followed during 5 years.

Detailed description

Radiofrequency ablation (RFA) of renal cell carcinoma (RCC) is actually used in elderly patients with small renal tumors (diameter ≤ 4 cm) and presenting a high risk of surgery (due to co-morbidity) and/or reduced renal function. RFA is a minimally invasive technique, considered as an alternative to surgery to limit morbidity and to preserve kidney function. The technique is well known and has proven his efficacy for the treatment of small tumors. An enlargement of the indications of RFA to patient without contra-indication to surgery will depend on the efficacy of the technique. The main objective of the study is to evaluate the local efficacy of the ablation based on the technical success, and on the evaluation of local cancer recurrence over 5 years.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient treated with percutaneous RFA * Patient with diagnosis of renal masses with a maximum of 3 masses treated during the ablation * The diameter of the tumor must be ≤ 40 mm, characterized by CT-scan or MRI * The histology of the tumor must be biopsy-proven or the patient must have previous surgical ablation of renal tumor (ipsi or contralateral)

Exclusion criteria

* Patient treated by surgery or laparoscopy * Benign tumors * No histological diagnosis (no biopsy or no previous treated renal carcinoma) * Patient having secondary malignant sites, ganglions or visceral metastatic cells or endo-venous extend at the time of RFA * Patient having a diagnosis of primary or secondary extra-renal tumor location and not into remission * Patients treated with antiangiogenic drugs during the 6 months prior RFA.

Design outcomes

Primary

Measure	Time frame
Rate of local efficacy of RFA treatment	60 months after the RFA treatment (D0)

Secondary

Measure	Time frame
Overall success	At 60 months after the RFA treatment (D0)
No recurrence of RCC	At 60 months after the RFA treatment (D0)
Tolerance of the treatment	At D0, 48 hours, 6, 12, 24, 36, 48 and 60 months after the RFA treatment (D0)

Countries

France

Outcome results