Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses (NORPN)

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).

Study Overview

• Status: Completed
• Conditions: Renal Tumor; Renal Malignant Tumor
• Intervention / Treatment: Procedure: Normotonic partial nephrectomy; Procedure: Hypotonic partial nephrectomy

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation
    • State University Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saint Petersburg State University, Russia
• Investigators: Study Director: Imran Dzhalilov, MD, Saint Petersburg State University, Russia; Principal Investigator: Vladislav Osetnik, MD, Saint Petersburg State University, Russia; Study Chair: Batyrbek Aslanov, PhD, Mechnikov North-West State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): May 7, 2022
• Study Completion (Actual): May 7, 2022

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: renal function; partial nephrectomy; zero ischaemia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: NORPN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not planning to share personal patient data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No