Renal Tumor Clinical Trial
— NORPNOfficial title:
Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses
NCT number | NCT04096534 |
Other study ID # | NORPN |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 7, 2019 |
Est. completion date | May 7, 2022 |
Verified date | May 2022 |
Source | Saint Petersburg State University, Russia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 108 |
Est. completion date | May 7, 2022 |
Est. primary completion date | May 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | State University Clinic | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Saint Petersburg State University, Russia |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Renal function | glomerular filtration rate calculation (mL/min), nephroscintigraphy | within the first 3 month after surgery | |
Primary | Blood loss | Volume of intraoperative blood loss (ml) | enrollment | |
Secondary | Disease-free survival | Survival without local or systemic recurrence (months) | 1 year after last patient enrolled | |
Secondary | Resection margins status | Evaluating of resection margins status (positive/negative) | enrollment |
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