Renal Malignant Tumor, Renal Tumor
Conditions
Keywords
partial nephrectomy, zero ischaemia, renal function
Brief summary
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
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.
Interventions
PROCEDURENormotonic partial nephrectomy
partial nephrectomy performing with avoidance of hypotension: mean blood pressure more or equal 65 mm Hg
PROCEDUREHypotonic partial nephrectomy
partial nephrectomy performing with using of medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg
Sponsors
Saint Petersburg State University, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal function | within the first 3 month after surgery | glomerular filtration rate calculation (mL/min), nephroscintigraphy |
| Blood loss | enrollment | Volume of intraoperative blood loss (ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 1 year after last patient enrolled | Survival without local or systemic recurrence (months) |
| Resection margins status | enrollment | Evaluating of resection margins status (positive/negative) |
Countries
Russia
Outcome results
None listed