Back to resultsThe Evaluation of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy
Primary Purpose
Renal Cell Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
On-clamp partial nephrectomy
Off-clamp partial nephrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring kidney cancer, partial nephrectomy, split renal function
Eligibility Criteria
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:
- Age < 18 years old or ASA> 3;
- Solitary kidney;
- Bilateral kidney
- The presence of concomitant systemic pathology (DM, AH), as well as kidney disease (glomerulonephritis), which can change the state of the renal parenchyma;
- Obstructive nephropathy
- Systemic intake of nephrotoxic drugs;
- Pregnancy. -
Sites / Locations
- Sechenov University.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
On-clamp partial nephrectomy
Off-clamp partial nephrectomy
Arm Description
Patients who are assigned to on-clamp partial nephrectomy.
Patients who are assigned to off-clamp partial nephrectomy.
Outcomes
Primary Outcome Measures
GFR after the surgery
Secondary Outcome Measures
Complication rate (Clavien-Dindo)
Full Information
NCT ID
NCT04798963
First Posted
March 11, 2021
Last Updated
March 11, 2021
Sponsor
I.M. Sechenov First Moscow State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04798963
Brief Title
The Evaluation of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy
Official Title
3D Assessment of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
March 2, 2022 (Anticipated)
Study Completion Date
March 2, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
kidney cancer, partial nephrectomy, split renal function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
On-clamp partial nephrectomy
Arm Type
Other
Arm Description
Patients who are assigned to on-clamp partial nephrectomy.
Arm Title
Off-clamp partial nephrectomy
Arm Type
Other
Arm Description
Patients who are assigned to off-clamp partial nephrectomy.
Intervention Type
Procedure
Intervention Name(s)
On-clamp partial nephrectomy
Intervention Description
Partial nephrectomy will performed with renal artery clamping (less than or equal to 25 minutes)
Intervention Type
Procedure
Intervention Name(s)
Off-clamp partial nephrectomy
Intervention Description
Partial nephrectomy will performed without renal artery clamping
Primary Outcome Measure Information:
Title
GFR after the surgery
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complication rate (Clavien-Dindo)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Age < 18 years old or ASA> 3;
Solitary kidney;
Bilateral kidney
The presence of concomitant systemic pathology (DM, AH), as well as kidney disease (glomerulonephritis), which can change the state of the renal parenchyma;
Obstructive nephropathy
Systemic intake of nephrotoxic drugs;
Pregnancy. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Fiev, M.D., Ph.D.
Phone
+79265690949
Email
fiev@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Enikeev, M.D., Ph.D.
Facility Information:
Facility Name
Sechenov University.
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Enikeev, MD
Phone
+7 925 517 79 26
Email
enikeev-dv@1msmu.ru
12. IPD Sharing Statement
Learn more about this trial
The Evaluation of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy
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