Renal Malignant TumorNORPNNCT04096534
Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses
A study testing Normotonic partial nephrectomy and Hypotonic partial nephrectomy in people with Renal Malignant Tumor and Renal Tumor, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
This study evaluates novel surgical approach in treating small renal masses. Half of participants will undergo hypotonic zero-ischaemia partial nephrectomy (standard of care), while the other half will undergo normotonic zero-ischaemia partial nephrectomy (experimental method). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Malignant Tumor, Renal Tumor
- What is being tested?
- Normotonic partial nephrectomy and Hypotonic partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteRussia
- Study dates
- 7 Oct 2019to 7 May 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected by computed tomography or another instrumental method renal mass
- Clinical stage T1-2N0-2M0-1 (distant metastases must be resectable)
- Indications for partial nephrectomy
- Eastern Cooperative Oncology Group status 0-2
- At least 18 years of age
- Written informed consent
Who cannot join
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
- Pregnancy or breast feeding
- Medical contraindications for surgical treatment
- Synchronous or metachronous malignancy
- Non-resectable distant metastases
- The patient's refusal to perform research procedures.
- Refusal of the patient to continue participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates novel surgical approach in treating small renal masses. Half of participants will undergo hypotonic zero-ischaemia partial nephrectomy (standard of care), while the other half will undergo normotonic zero-ischaemia partial nephrectomy (experimental method).
Read the detailed description
Partial nephrectomy is believed to be the gold standard for treating small renal masses (SRM). The warm ischaemia and hypotonic zero-ischaemia approach are widely used techniques of care. But they have some negative effects according to renal function (RF) after surgery. We decided to compare influence of arterial blood pressure (normotension or hypotension) during partial nephrectomy on RF.
A single-center prospective study comparing normotonic and hypotonic partial nephrectomy will be conducted.
The design involves random allocation of eligible patients to normotonic or hypotonic partial nephrectomy group in 1:1 ratio.
Experimental group - normotonic partial nephrectomy (avoidance of hypotension: mean blood pressure more or equal 65 mm Hg).
Control group - hypotonic partial nephrectomy (using medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg
According to preliminary calculations, taking into account type I error of 5% and power of 80%, 100 patients should be included in the study. In order to compensate for data loss, the estimated sample size is increased by 10%. As a result, the total sample size is 100 +10 = 110 patients (55 patients for each group). The expected duration of the study is 36 months.
- Conditions
- Renal Malignant Tumor, Renal Tumor
- Being tested
- Normotonic partial nephrectomy, Hypotonic partial nephrectomy
- Keywords
- partial nephrectomy, zero ischaemia, renal function
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normotonic partial nephrectomyProcedure or surgery
partial nephrectomy performing with avoidance of hypotension: mean blood pressure more or equal 65 mm Hg
Hypotonic partial nephrectomyProcedure or surgery
partial nephrectomy performing with using of medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Normotonic partial nephrectomy | Experimental | Performing a partial nephrectomy under normal body blood pressure Receives: Procedure: Normotonic partial nephrectomy |
| Hypotonic partial nephrectomy | Active comparator | Performing a partial nephrectomy under hypotonic body blood pressure Receives: Procedure: Hypotonic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
glomerular filtration rate calculation (mL/min), nephroscintigraphy
Measured: within the first 3 month after surgery
Blood loss
Volume of intraoperative blood loss (ml)
Measured: enrollment
Secondary outcomes (2)
Disease-free survival
Survival without local or systemic recurrence (months)
Measured: 1 year after last patient enrolled
Resection margins status
Evaluating of resection margins status (positive/negative)
Measured: enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start7 Oct 2019
- Primary completion7 May 2022
- Study completion7 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Malignant TumorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladislav Osetnik, Saint Petersburg State University, Russia
- Investigators
- Imran Dzhalilov, MD, Study director, Saint Petersburg State University, RussiaVladislav Osetnik, MD, Principal investigator, Saint Petersburg State University, RussiaBatyrbek Aslanov, PhD, Study chair, Mechnikov North-West State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096534
- Sponsor's protocol ID
- NORPN
- Acronym
- NORPN
- Status last verified
- May 2022
- First submitted
- 18 Sep 2019
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning to share personal patient data
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses
- ClinicalTrials.gov ID
- NCT04096534
- Acronym / sponsor ID
- NORPN / NORPN
- Conditions
- Renal Malignant Tumor, Renal Tumor
- Keywords
- partial nephrectomy, zero ischaemia, renal function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 7 May 2022 (actual)
- Study completion
- 7 May 2022 (actual)
- First posted
- 20 Sep 2019 (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.
This study evaluates novel surgical approach in treating small renal masses. Half of participants will undergo hypotonic zero-ischaemia partial nephrectomy (standard of care), while the other half will undergo normotonic zero-ischaemia partial nephrectomy (experimental method).
Detailed description
Partial nephrectomy is believed to be the gold standard for treating small renal masses (SRM). The warm ischaemia and hypotonic zero-ischaemia approach are widely used techniques of care. But they have some negative effects according to renal function (RF) after surgery. We decided to compare influence of arterial blood pressure (normotension or hypotension) during partial nephrectomy on RF.
A single-center prospective study comparing normotonic and hypotonic partial nephrectomy will be conducted.
The design involves random allocation of eligible patients to normotonic or hypotonic partial nephrectomy group in 1:1 ratio.
Experimental group - normotonic partial nephrectomy (avoidance of hypotension: mean blood pressure more or equal 65 mm Hg).
Control group - hypotonic partial nephrectomy (using medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg
According to preliminary calculations, taking into account type I error of 5% and power of 80%, 100 patients should be included in the study. In order to compensate for data loss, the estimated sample size is increased by 10%. As a result, the total sample size is 100 +10 = 110 patients (55 patients for each group). The expected duration of the study is 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normotonic partial nephrectomy | Experimental | Procedure: Normotonic partial nephrectomyPerforming a partial nephrectomy under normal body blood pressure |
| Hypotonic partial nephrectomy | Active comparator | Procedure: Hypotonic partial nephrectomyPerforming a partial nephrectomy under hypotonic body blood pressure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Suspected by computed tomography or another instrumental method renal mass
- Clinical stage T1-2N0-2M0-1 (distant metastases must be resectable)
- Indications for partial nephrectomy
- Eastern Cooperative Oncology Group status 0-2
- At least 18 years of age
Key exclusion criteria (7 listed)
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
- Pregnancy or breast feeding
- Medical contraindications for surgical treatment
- Synchronous or metachronous malignancy
- Non-resectable distant metastases
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 |
|---|---|---|
| Normotonic partial nephrectomypartial nephrectomy performing with avoidance of hypotension: mean blood pressure more or equal 65 mm Hg | Procedure or surgery | Normotonic partial nephrectomy |
| Hypotonic partial nephrectomypartial nephrectomy performing with using of medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg | Procedure or surgery | Hypotonic partial nephrectomy |
Primary outcome
Renal function
Time frame: within the first 3 month after surgery
glomerular filtration rate calculation (mL/min), nephroscintigraphy
Blood loss
Time frame: enrollment
Volume of intraoperative blood loss (ml)
2 secondary outcomes
Disease-free survival
Time frame: 1 year after last patient enrolled
Resection margins status
Time frame: enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No. We are not planning to share personal patient data
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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.
Imran Dzhalilov, MD study director
Saint Petersburg State University, Russia
Vladislav Osetnik, MD principal investigator
Saint Petersburg State University, Russia
Batyrbek Aslanov, PhD study chair
Mechnikov North-West State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normotonic partial nephrectomy and Hypotonic partial nephrectomy in people with Renal Malignant Tumor and Renal Tumor, run by Saint Petersburg State University, Russia 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 6 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: finished, as of the sponsor's last update on 25 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function (time frame: within the first 3 month after surgery). The study lists 2 primary outcomes in all. 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 25 May 2022.