Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-04-05 @ 9:39 AM
Study NCT ID:
NCT01891032
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Acute Renal Injury During Partial Nephrectomy Using Neutrophil Gelatinase-associated Lipocalin (NGAL): Prospective Comparative Study Between Open, Video-assisted Minilaparotomy, Laparoscopic, and Robotic-assisted Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-24', 'studyFirstSubmitDate': '2013-06-27', 'studyFirstSubmitQcDate': '2013-06-27', 'lastUpdatePostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The level of urinary NGAL', 'timeFrame': 'changes from Preoperative, postop 3hr, 24hr, 48hrs after partial nephrectomy', 'description': 'Analysis of correlation between the level of preoperative and postoperative urinary NGAL'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute kidney injury, partial nephrectomy, biomarker'], 'conditions': ['the Patients With Partial Nephrectomy']}, 'descriptionModule': {'briefSummary': 'Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of acute kidney injury. We are trying to analyze whether it is related with the grade of acute kiney injury after partial nephrectomy and there is any difference between the kinds of surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. the adult patients with open partial nephrectomy\n2. the adult patients with laparoscopic partial nephrectomy\n3. the adult patients with VAMS partial nephrectomy, 4: the adult patients with robotic partial nephrectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adults patient more than 20 years old with ASA score 1-3\n2. the patients who undergoing partial nephrectomy for the renal mass less than 7 cm\n\nExclusion Criteria:\n\n1. the patient with previous history with renal surgery\n2. the patient with bilateral partial nephrectomy\n3. the patient with synchronous operation for other intraperitoneal surgery\n4. the renal mass more than 7 cm\n5. previous kinds of surgery is changed into other kinds due to bleeding, etc\n6. the patient with serum Cr level more than 1.4 mg/dl\n7. the patient who does not understand the consent form'}, 'identificationModule': {'nctId': 'NCT01891032', 'briefTitle': 'Assessment of Acute Renal Injury During Partial Nephrectomy Using Neutrophil Gelatinase-associated Lipocalin (NGAL): Prospective Comparative Study Between Open, Video-assisted Minilaparotomy, Laparoscopic, and Robotic-assisted Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2013-0261'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the patients with open partial nephrectomy', 'description': 'the adult patients with open partial nephrectomy'}, {'label': 'laparoscopic', 'description': 'the adult patients with laparoscopic partial nephrectomy'}, {'label': 'VAMS', 'description': 'the adult patients with VAMS partial nephrectomy'}, {'label': 'robotic', 'description': 'the adult patients with robotic partial nephrectomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}