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NCT Number: NCT04096534

Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses

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).

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Key information

Conditions

Renal Malignant Tumor Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Tumor Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State University Clinic

Saint Petersburg, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Normotonic partial nephrectomy

Procedure

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

Hypotonic partial nephrectomy

Procedure

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Acronym: NORPN

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 20, 2019
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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