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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04096534
Other study ID # NORPN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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