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

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ClinicalTrials.gov Identifier: NCT04096534
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Vladislav Osetnik, Saint Petersburg State University, Russia

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).

Condition or disease Intervention/treatment Phase
Renal Malignant Tumor Renal Tumor Procedure: Normotonic partial nephrectomy Procedure: Hypotonic partial nephrectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : February 7, 2021
Estimated Study Completion Date : October 7, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Renal function [ Time Frame: within the first 3 month after surgery ]
    glomerular filtration rate calculation (mL/min), nephroscintigraphy

  2. Blood loss [ Time Frame: enrollment ]
    Volume of intraoperative blood loss (ml)


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 1 year after last patient enrolled ]
    Survival without local or systemic recurrence (months)

  2. Resection margins status [ Time Frame: enrollment ]
    Evaluating of resection margins status (positive/negative)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096534


Contacts
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Contact: Vladislav Osetnik, MD 89312064346 osetnik@bk.ru
Contact: Eldar Mamijev, MD 89217696923 mamijev@mail.ru

Locations
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Russian Federation
State University Clinic Recruiting
Saint Petersburg, Russian Federation
Contact: Vladislav Osetnik, MD         
Sponsors and Collaborators
Saint Petersburg State University, Russia
Investigators
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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
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Responsible Party: Vladislav Osetnik, Principal Investigator, Saint Petersburg State University, Russia
ClinicalTrials.gov Identifier: NCT04096534    
Other Study ID Numbers: NORPN
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are not planning to share personal patient data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vladislav Osetnik, Saint Petersburg State University, Russia:
partial nephrectomy
zero ischaemia
renal function
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type