Clinical trial NCT04096534: Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses
Official title: Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Malignant Tumor
Renal Tumor
Keywords: partial nephrectomy
zero ischaemia
renal function
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Renal function
timeFrame: within the first 3 month after surgery
measure: Blood loss
timeFrame: enrollment
Secondary outcomes:
measure: Disease-free survival
timeFrame: 1 year after last patient enrolled
measure: Resection margins status
timeFrame: enrollment
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: State University Clinic
Study officials:
affiliation: Saint Petersburg State University, Russia
name: Imran Dzhalilov, MD
role: STUDY_DIRECTOR
affiliation: Saint Petersburg State University, Russia
name: Vladislav Osetnik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mechnikov North-West State Medical University
name: Batyrbek Aslanov, PhD
role: STUDY_CHAIR
References: