Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses

NCT ID: NCT04096534

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2022-05-07

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.

Conditions

Renal Malignant Tumor; Renal Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normotonic partial nephrectomy

Performing a partial nephrectomy under normal body blood pressure

Group Type: EXPERIMENTAL

Normotonic partial nephrectomy

Intervention Type: PROCEDURE

partial nephrectomy performing with avoidance of hypotension: mean blood pressure more or equal 65 mm Hg

Hypotonic partial nephrectomy

Performing a partial nephrectomy under hypotonic body blood pressure

Group Type: ACTIVE_COMPARATOR

Hypotonic partial nephrectomy

Intervention Type: PROCEDURE

partial nephrectomy performing with using of medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg

Interventions

Normotonic partial nephrectomy

partial nephrectomy performing with avoidance of hypotension: mean blood pressure more or equal 65 mm Hg

Intervention Type: PROCEDURE

Hypotonic partial nephrectomy

partial nephrectomy performing with using of medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Petersburg State University, Russia

OTHER

Sponsor Role: lead

Responsible Party

Vladislav Osetnik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Imran Dzhalilov, MD

Role: STUDY_DIRECTOR

Saint Petersburg State University, Russia

Vladislav Osetnik, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Petersburg State University, Russia

Batyrbek Aslanov, PhD

Role: STUDY_CHAIR

Mechnikov North-West State Medical University

Locations

State University Clinic

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

NORPN

Identifier Type: -

Identifier Source: org_study_id