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

I.M. Sechenov First Moscow State Medical University

Status: Unknown

Conditions: Renal Cell Carcinoma

Treatments: Procedure: Off-clamp partial nephrectomy; Procedure: On-clamp partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04798963

MACT-PN 2021

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

On-clamp partial nephrectomy

Other group

Description:

Patients who are assigned to on-clamp partial nephrectomy.

Treatment:

Procedure: On-clamp partial nephrectomy

Off-clamp partial nephrectomy

Other group

Description:

Patients who are assigned to off-clamp partial nephrectomy.

Treatment:

Procedure: Off-clamp partial nephrectomy