Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses

Not Applicable

Completed

• Conditions: Renal Tumor; Renal Malignant Tumor
• Interventions: Procedure: Hypotonic partial nephrectomy; Procedure: Normotonic partial nephrectomy

• Registration Number: NCT04096534
• Lead Sponsor: Saint Petersburg State University, Russia

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.

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-20
• Study Start: 2019-10-07
• Status Verified: 2022-05
• Primary Completion: 2022-05-07
• Study Completion: 2022-05-07
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypotonic partial nephrectomy	Hypotonic partial nephrectomy	Performing a partial nephrectomy under hypotonic body blood pressure
Normotonic partial nephrectomy	Normotonic partial nephrectomy	Performing a partial nephrectomy under normal body blood pressure

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

State University Clinic; 🇷🇺 Saint Petersburg, Russian Federation