Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-04-15 @ 12:58 PM
Study NCT ID:
NCT01892059
Status:
UNKNOWN
Last Update Posted:
2013-07-03
First Post:
2013-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Segmental Renal Artery Clamping During Laparoscopic Partial Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-02', 'studyFirstSubmitDate': '2013-06-30', 'studyFirstSubmitQcDate': '2013-07-02', 'lastUpdatePostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'estimated blood loss', 'timeFrame': 'during surgery'}], 'primaryOutcomes': [{'measure': 'Glomerular Filtration Rate', 'timeFrame': '3 months postoperative'}], 'secondaryOutcomes': [{'measure': 'warm ischemia time', 'timeFrame': 'during surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['renal tumour', 'partial nephrectomy', 'laparoscope', 'segmental renal artery clamping'], 'conditions': ['Kidney Neoplasms', 'Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '22695243', 'type': 'BACKGROUND', 'citation': 'Shao P, Tang L, Li P, Xu Y, Qin C, Cao Q, Ju X, Meng X, Lv Q, Li J, Zhang W, Yin C. Precise segmental renal artery clamping under the guidance of dual-source computed tomography angiography during laparoscopic partial nephrectomy. Eur Urol. 2012 Dec;62(6):1001-8. doi: 10.1016/j.eururo.2012.05.056. Epub 2012 Jun 7.'}, {'pmid': '23116655', 'type': 'BACKGROUND', 'citation': 'Shao P, Tang L, Li P, Xu Y, Qin C, Cao Q, Ju X, Meng X, Lv Q, Li J, Zhang W, Yin C. Application of a vasculature model and standardization of the renal hilar approach in laparoscopic partial nephrectomy for precise segmental artery clamping. Eur Urol. 2013 Jun;63(6):1072-81. doi: 10.1016/j.eururo.2012.10.017. Epub 2012 Oct 24.'}, {'pmid': '21146917', 'type': 'RESULT', 'citation': 'Shao P, Qin C, Yin C, Meng X, Ju X, Li J, Lv Q, Zhang W, Xu Z. Laparoscopic partial nephrectomy with segmental renal artery clamping: technique and clinical outcomes. Eur Urol. 2011 May;59(5):849-55. doi: 10.1016/j.eururo.2010.11.037. Epub 2010 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and safety of the segmental artery clamping and main renal artery clamping during laparoscopic partial nephrectomy', 'detailedDescription': 'Renal tumor patients,for whom laparoscopic partial nephrectomy is suitable, will be randomly divided into two groups,segmental artery clamping group and main artery clamping group. All procedures were performed by the same laparoscopic surgeon. Blood loss, operation time, warm ischemia time, complications and affected renal function before and after operation will be recorded and compared. The safety and efficiency of laparoscopic partial nephrectomy with segmental renal artery clamping will be evaluated in comparison with the conventional main renal artery clamping technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20\\<age\\<70yr\n* Stage T1a\n* Patients volunteered for this study and provided written informed consent\n\nExclusion Criteria:\n\n* Bilateral renal tumor\n* tumor of solitary kidney\n* glomerulonephritis\n* renal insufficiency\n* GFR of invalid kidney less than 30ml/min\n* presence of suspect metastasis\n* serious systematic disease: severe coagulation disorders\n* important organ insufficiency and severe psychological disease'}, 'identificationModule': {'nctId': 'NCT01892059', 'briefTitle': 'Study of Segmental Renal Artery Clamping During Laparoscopic Partial Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'A Randomized Controlled Trial Comparing the Segmental Artery Clamping and Main Renal Artery Clamping During Laparoscopic Partial Nephrectomy', 'orgStudyIdInfo': {'id': 'ChiCTR-TRC-13003054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Segmental artery clamping', 'description': 'Patients with Renal tumor are randomized into this group,they will received laparoscopic partial nephrectomy. During operation, the technique of segmental renal artery clamping will performed.', 'interventionNames': ['Procedure: Segmental artery clamping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Main renal artery clamping', 'description': 'Patients with renal tumor are randomized into this group,they will received laparoscopic partial nephrectomy. During operation, the technique of traditional main renal artery clamping will be performed.', 'interventionNames': ['Procedure: Main renal artery clamping']}], 'interventions': [{'name': 'Segmental artery clamping', 'type': 'PROCEDURE', 'description': 'Laparoscopic partial nephrectomy with segmental artery clamping will be performed for patients enrolled in this group.', 'armGroupLabels': ['Segmental artery clamping']}, {'name': 'Main renal artery clamping', 'type': 'PROCEDURE', 'description': 'Laparoscopic partial nephrectomy with main renal artery clamping technique will be performed for patients enrolled in this group.', 'armGroupLabels': ['Main renal artery clamping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pu Li', 'role': 'CONTACT', 'email': 'lee_lipu@163.com', 'phone': '+25 68136875'}, {'name': 'Changjun Yin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Urology, First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Changjun Yin, MD, PHD', 'role': 'CONTACT', 'email': 'lee_lipu@163.com', 'phone': '+86 25-68136319'}, {'name': 'Pengfei Shao, MD, PHD', 'role': 'CONTACT', 'email': 'spf032@hotmail.com', 'phone': '+86 25-68136851'}], 'overallOfficials': [{'name': 'Changjun Yin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Urology Department', 'investigatorFullName': 'Changjun Yin', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}