The Evaluation of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy

March 11, 2021 updated by: Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University

3D Assessment of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy

The study aims to compare pre- and postoperative 3D renal function results of patients who underwent on-clamp and off-clamp partial nephrectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dmitry Fiev, M.D., Ph.D.
  • Phone Number: +79265690949
  • Email: fiev@mail.ru

Study Contact Backup

  • Name: Dmitry Enikeev, M.D., Ph.D.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Men and women >18 years; 2. Diagnosis of unilateral renal cell carcinoma (stage T1-T3aN0M0); 3. Planned surgery: retroperitoneoscopic/laparoscopic/robotic partial nephrectomy; 4. Patients with CT of the kidneys with contrast enhancement performed according to the required protocol.

-

Exclusion Criteria:

  1. Age < 18 years old or ASA> 3;
  2. Solitary kidney;
  3. Bilateral kidney
  4. The presence of concomitant systemic pathology (DM, AH), as well as kidney disease (glomerulonephritis), which can change the state of the renal parenchyma;
  5. Obstructive nephropathy
  6. Systemic intake of nephrotoxic drugs;
  7. Pregnancy. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: On-clamp partial nephrectomy
Patients who are assigned to on-clamp partial nephrectomy.
Procedure: On-clamp partial nephrectomy
Partial nephrectomy will performed with renal artery clamping (less than or equal to 25 minutes)
Other: Off-clamp partial nephrectomy
Patients who are assigned to off-clamp partial nephrectomy.
Procedure: Off-clamp partial nephrectomy
Partial nephrectomy will performed without renal artery clamping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GFR after the surgery
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Complication rate (Clavien-Dindo)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Anticipated)

March 2, 2022

Study Completion (Anticipated)

March 2, 2022

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MACT-PN 2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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