Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses

Renal Tumor Clinical Trial

— NORPN  

Official title:

Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04096534
• Other study ID #: NORPN
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: May 7, 2022

Study information

• Verified date: May 2022
• Source: Saint Petersburg State University, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 7, 2022
• Est. primary completion date: May 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Neoplasms
• Renal Malignant Tumor
• Renal Tumor

Intervention

Procedure:
• Normotonic partial nephrectomy
partial nephrectomy performing with avoidance of hypotension: mean blood pressure more or equal 65 mm Hg
• Hypotonic partial nephrectomy
partial nephrectomy performing with using of medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg

Locations

Country	Name	City	State
Russian Federation	State University Clinic	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function	glomerular filtration rate calculation (mL/min), nephroscintigraphy	within the first 3 month after surgery
Primary	Blood loss	Volume of intraoperative blood loss (ml)	enrollment
Secondary	Disease-free survival	Survival without local or systemic recurrence (months)	1 year after last patient enrolled
Secondary	Resection margins status	Evaluating of resection margins status (positive/negative)	enrollment