Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT04096534
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2019-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2019-09-18', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal function', 'timeFrame': 'within the first 3 month after surgery', 'description': 'glomerular filtration rate calculation (mL/min), nephroscintigraphy'}, {'measure': 'Blood loss', 'timeFrame': 'enrollment', 'description': 'Volume of intraoperative blood loss (ml)'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '1 year after last patient enrolled', 'description': 'Survival without local or systemic recurrence (months)'}, {'measure': 'Resection margins status', 'timeFrame': 'enrollment', 'description': 'Evaluating of resection margins status (positive/negative)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['partial nephrectomy', 'zero ischaemia', 'renal function'], 'conditions': ['Renal Malignant Tumor', 'Renal Tumor']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nA single-center prospective study comparing normotonic and hypotonic partial nephrectomy will be conducted.\n\nThe design involves random allocation of eligible patients to normotonic or hypotonic partial nephrectomy group in 1:1 ratio.\n\nExperimental group - normotonic partial nephrectomy (avoidance of hypotension: mean blood pressure more or equal 65 mm Hg).\n\nControl group - hypotonic partial nephrectomy (using medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg\n\nAccording 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Suspected by computed tomography or another instrumental method renal mass\n* Clinical stage T1-2N0-2M0-1 (distant metastases must be resectable)\n* Indications for partial nephrectomy\n* Eastern Cooperative Oncology Group status 0-2\n* At least 18 years of age\n* Written informed consent\n\nExclusion Criteria:\n\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol\n* Pregnancy or breast feeding\n* Medical contraindications for surgical treatment\n* Synchronous or metachronous malignancy\n* Non-resectable distant metastases\n* The patient's refusal to perform research procedures.\n* Refusal of the patient to continue participation in the study."}, 'identificationModule': {'nctId': 'NCT04096534', 'acronym': 'NORPN', 'briefTitle': 'Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses', 'organization': {'class': 'OTHER', 'fullName': 'Saint Petersburg State University, Russia'}, 'officialTitle': 'Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses', 'orgStudyIdInfo': {'id': 'NORPN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normotonic partial nephrectomy', 'description': 'Performing a partial nephrectomy under normal body blood pressure', 'interventionNames': ['Procedure: Normotonic partial nephrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypotonic partial nephrectomy', 'description': 'Performing a partial nephrectomy under hypotonic body blood pressure', 'interventionNames': ['Procedure: Hypotonic partial nephrectomy']}], 'interventions': [{'name': 'Normotonic partial nephrectomy', 'type': 'PROCEDURE', 'description': 'partial nephrectomy performing with avoidance of hypotension: mean blood pressure more or equal 65 mm Hg', 'armGroupLabels': ['Normotonic partial nephrectomy']}, {'name': 'Hypotonic partial nephrectomy', 'type': 'PROCEDURE', 'description': 'partial nephrectomy performing with using of medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg', 'armGroupLabels': ['Hypotonic partial nephrectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'State University Clinic', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Imran Dzhalilov, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Saint Petersburg State University, Russia'}, {'name': 'Vladislav Osetnik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Petersburg State University, Russia'}, {'name': 'Batyrbek Aslanov, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mechnikov North-West State Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We are not planning to share personal patient data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Petersburg State University, Russia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vladislav Osetnik', 'investigatorAffiliation': 'Saint Petersburg State University, Russia'}}}}