Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses

  • STATUS
    Recruiting
  • End date
    Oct 7, 2022
  • participants needed
    110
  • sponsor
    Saint Petersburg State University, Russia
Updated on 30 April 2021
ct scan
ischemia
metastasis
nephrectomy

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).

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.

Details
Condition Malignant neoplasm of kidney, Kidney Cancer, Renal Cancer, cancer, renal, kidney tumor, renal tumors, neoplasia renal, renal neoplasm, renal tumor, kidney tumours, kidney tumors
Treatment Normotonic partial nephrectomy, Hypotonic partial nephrectomy
Clinical Study IdentifierNCT04096534
SponsorSaint Petersburg State University, Russia
Last Modified on30 April 2021

Eligibility

Yes No Not Sure

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
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