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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04798963
• Other study ID #: MACT-PN 2021
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2021
• Est. completion date: March 2, 2022

Study information

• Verified date: March 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Dmitry Fiev, M.D., Ph.D.
• Phone: +79265690949
• Email: fiev[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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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. -

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Procedure:
• On-clamp partial nephrectomy
Partial nephrectomy will performed with renal artery clamping (less than or equal to 25 minutes)
• Off-clamp partial nephrectomy
Partial nephrectomy will performed without renal artery clamping

Locations

Country	Name	City	State
Russian Federation	Sechenov University.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GFR after the surgery		6 months
Secondary	Complication rate (Clavien-Dindo)		3 months