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

Not Applicable

• Conditions: Renal Cell Carcinoma
• Interventions: Procedure: Off-clamp partial nephrectomy; Procedure: On-clamp partial nephrectomy

• Registration Number: NCT04798963
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-02
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-11
• Last Update Submitted: 2021-03-11
• Study First Posted: 2021-03-16
• Last Update Posted: 2021-03-16
• Primary Completion: 2022-03-02
• Study Completion: 2022-03-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Off-clamp partial nephrectomy	Off-clamp partial nephrectomy	Patients who are assigned to off-clamp partial nephrectomy.
On-clamp partial nephrectomy	On-clamp partial nephrectomy	Patients who are assigned to on-clamp partial nephrectomy.

Primary Outcome Measures

Name	Time	Method
GFR after the surgery	6 months

Secondary Outcome Measures

Name	Time	Method
Complication rate (Clavien-Dindo)	3 months

Trial Locations

Locations (1)

Sechenov University.; 🇷🇺 Moscow, Russian Federation