The Evaluation of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy
3D Assessment of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 2, 2021
CompletedFirst Submitted
Initial submission to the registry
March 11, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2022
CompletedMarch 16, 2021
March 1, 2021
1 year
March 11, 2021
March 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
GFR after the surgery
6 months
Secondary Outcomes (1)
Complication rate (Clavien-Dindo)
3 months
Study Arms (2)
On-clamp partial nephrectomy
OTHERPatients who are assigned to on-clamp partial nephrectomy.
Off-clamp partial nephrectomy
OTHERPatients who are assigned to off-clamp partial nephrectomy.
Interventions
Partial nephrectomy will performed with renal artery clamping (less than or equal to 25 minutes)
Partial nephrectomy will performed without renal artery clamping
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sechenov University.
Moscow, 119991, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Dmitry Enikeev, M.D., Ph.D.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director for Research
Study Record Dates
First Submitted
March 11, 2021
First Posted
March 16, 2021
Study Start
March 2, 2021
Primary Completion
March 2, 2022
Study Completion
March 2, 2022
Last Updated
March 16, 2021
Record last verified: 2021-03