Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses

NCT04096534 | Completed

• 1 other identifier: NORPN
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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).

Conditions

Renal Malignant Tumor; Renal Tumor

Keywords

partial nephrectomy; zero ischaemia; renal function

Outcome Measures

Primary Outcomes (2)

• Renal function

  glomerular filtration rate calculation (mL/min), nephroscintigraphy

  within the first 3 month after surgery

• Blood loss

  Volume of intraoperative blood loss (ml)

  enrollment

Secondary Outcomes (2)

• Disease-free survival

  1 year after last patient enrolled

• Resection margins status

  enrollment

Study Arms (2)

Normotonic partial nephrectomy

EXPERIMENTAL

Performing a partial nephrectomy under normal body blood pressure

Procedure: Normotonic partial nephrectomy

Hypotonic partial nephrectomy

ACTIVE COMPARATOR

Performing a partial nephrectomy under hypotonic body blood pressure

Procedure: Hypotonic partial nephrectomy

Interventions

Normotonic partial nephrectomy PROCEDURE

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

Normotonic partial nephrectomy

Hypotonic partial nephrectomy PROCEDURE

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

Hypotonic partial nephrectomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

State University Clinic

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Imran Dzhalilov, MD

  Saint Petersburg State University, Russia

  STUDY DIRECTOR

• Vladislav Osetnik, MD

  Saint Petersburg State University, Russia

  PRINCIPAL INVESTIGATOR

• Batyrbek Aslanov, PhD

  Mechnikov North-West State Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: October 7, 2019
• Primary Completion: May 7, 2022
• Study Completion: May 7, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)