Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses

Study Overview
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Brief Summary
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This study evaluates novel surgical approach in treating small renal masses. Half of participants will undergo hypotonic zero-ischaemia partial nephrectomy (standard of care), while the other half will undergo normotonic zero-ischaemia partial nephrectomy (experimental method).

Detailed Description
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Partial nephrectomy is believed to be the gold standard for treating small renal masses (SRM). The warm ischaemia and hypotonic zero-ischaemia approach are widely used techniques of care. But they have some negative effects according to renal function (RF) after surgery. We decided to compare influence of arterial blood pressure (normotension or hypotension) during partial nephrectomy on RF. A single-center prospective study comparing normotonic and hypotonic partial nephrectomy will be conducted. The design involves random allocation of eligible patients to normotonic or hypotonic partial nephrectomy group in 1:1 ratio. Experimental group - normotonic partial nephrectomy (avoidance of hypotension: mean blood pressure more or equal 65 mm Hg). Control group - hypotonic partial nephrectomy (using medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg According to preliminary calculations, taking into account type I error of 5% and power of 80%, 100 patients should be included in the study. In order to compensate for data loss, the estimated sample size is increased by 10%. As a result, the total sample size is 100 +10 = 110 patients (55 patients for each group). The expected duration of the study is 36 months.

Official Title
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Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses

Conditions
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Renal Malignant Tumor, Renal Tumor

Intervention / Treatment
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* Procedure: Normotonic partial nephrectomy
* Procedure: Hypotonic partial nephrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected by computed tomography or another instrumental method renal mass Clinical stage T1-2N0-2M0-1 (distant metastases must be resectable) Indications for partial nephrectomy Eastern Cooperative Oncology Group status 0-2 At least 18 years of age Written informed consent Exclusion Criteria: Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol Pregnancy or breast feeding Medical contraindications for surgical treatment Synchronous or metachronous malignancy Non-resectable distant metastases The patient's refusal to perform research procedures. Refusal of the patient to continue participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normotonic partial nephrectomy<br>Performing a partial nephrectomy under normal body blood pressure | Procedure: Normotonic partial nephrectomy<br>* partial nephrectomy performing with avoidance of hypotension: mean blood pressure more or equal 65 mm Hg<br>|
| Active Comparator: Hypotonic partial nephrectomy<br>Performing a partial nephrectomy under hypotonic body blood pressure | Procedure: Hypotonic partial nephrectomy<br>* partial nephrectomy performing with using of medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function | glomerular filtration rate calculation (mL/min), nephroscintigraphy | within the first 3 month after surgery | 
| Blood loss | Volume of intraoperative blood loss (ml) | enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Survival without local or systemic recurrence (months) | 1 year after last patient enrolled | 
| Resection margins status | Evaluating of resection margins status (positive/negative) | enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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partial nephrectomy, zero ischaemia, renal function