Renal Cell CarcinomaNCT04798963
The Evaluation of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy
A study testing On-clamp partial nephrectomy and Off-clamp partial nephrectomy in people with Renal Cell Carcinoma, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- On-clamp partial nephrectomy and Off-clamp partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 2 Mar 2021to 2 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
Dmitry Enikeev, M.D., Ph.D. contact
Russia1 site, 1 recruiting
- Recruiting
Sechenov University.
Moscow, 119991
Dmitry Enikeev, MD, +7 925 517 79 26, enikeev-dv@1msmu.ru
About this study
Official title: 3D Assessment of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy
The study aims to compare pre- and postoperative 3D renal function results of patients who underwent on-clamp and off-clamp partial nephrectomy.
- Conditions
- Renal Cell Carcinoma
- Being tested
- On-clamp partial nephrectomy, Off-clamp partial nephrectomy
- Keywords
- kidney cancer, partial nephrectomy, split renal function
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-clamp partial nephrectomyProcedure or surgery
Partial nephrectomy will performed with renal artery clamping (less than or equal to 25 minutes)
Off-clamp partial nephrectomyProcedure or surgery
Partial nephrectomy will performed without renal artery clamping
| Study group | Role | What they receive |
|---|---|---|
| On-clamp partial nephrectomy | Other | Patients who are assigned to on-clamp partial nephrectomy. Receives: Procedure: On-clamp partial nephrectomy |
| Off-clamp partial nephrectomy | Other | Patients who are assigned to off-clamp partial nephrectomy. Receives: Procedure: Off-clamp partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR after the surgery
Measured: 6 months
Secondary outcomes (1)
Complication rate (Clavien-Dindo)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start2 Mar 2021
- Primary completion2 Mar 2022 (estimated)
- Study completion2 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798963
- Sponsor's protocol ID
- MACT-PN 2021
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Assessment of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT04798963
- Acronym / sponsor ID
- MACT-PN 2021
- Conditions
- Renal Cell Carcinoma
- Keywords
- kidney cancer, partial nephrectomy, split renal function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 2 Mar 2022 (estimated)
- Study completion
- 2 Mar 2022 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to compare pre- and postoperative 3D renal function results of patients who underwent on-clamp and off-clamp partial nephrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-clamp partial nephrectomy | Other | Procedure: On-clamp partial nephrectomyPatients who are assigned to on-clamp partial nephrectomy. |
| Off-clamp partial nephrectomy | Other | Procedure: Off-clamp partial nephrectomyPatients who are assigned to off-clamp partial nephrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-clamp partial nephrectomyPartial nephrectomy will performed with renal artery clamping (less than or equal to 25 minutes) | Procedure or surgery | On-clamp partial nephrectomy |
| Off-clamp partial nephrectomyPartial nephrectomy will performed without renal artery clamping | Procedure or surgery | Off-clamp partial nephrectomy |
Primary outcome
GFR after the surgery
Time frame: 6 months
1 secondary outcome
Complication rate (Clavien-Dindo)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitry Enikeev, M.D., Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-clamp partial nephrectomy and Off-clamp partial nephrectomy in people with Renal Cell Carcinoma, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Fiev, M.D., Ph.D. (+79265690949, fiev@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GFR after the surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.