Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT01838720
Status:
UNKNOWN
Last Update Posted:
2014-08-13
First Post:
2013-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D007511', 'term': 'Ischemia'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-12', 'studyFirstSubmitDate': '2013-04-14', 'studyFirstSubmitQcDate': '2013-04-20', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the absolute change in glomerular filtration rate (GFR) of the affected kidney', 'timeFrame': 'baseline and 12 months', 'description': '12 months minus baseline'}], 'secondaryOutcomes': [{'measure': 'estimated GFR (eGFR)', 'timeFrame': '12 months'}, {'measure': 'changes in GFR of total kidneys by renal scintigraphyby', 'timeFrame': 'baseline and 12 months'}, {'measure': 'blood loss', 'timeFrame': 'during surgery'}, {'measure': 'surgical margin', 'timeFrame': 'postoperative', 'description': 'pathologic confirm of surgical margin'}, {'measure': 'postoperative complications', 'timeFrame': '12 months'}, {'measure': 'progression-free survival', 'timeFrame': '12 months'}, {'measure': 'local recurrence', 'timeFrame': '12 months'}, {'measure': 'the absolute change in glomerular filtration rate (GFR) of the affected kidney', 'timeFrame': 'baseline and 6 months', 'description': '6 months minus baseline'}, {'measure': 'estimated GFR (eGFR) of 6 month', 'timeFrame': '6 month'}, {'measure': 'changes in GFR of total kidneys by renal scintigraphyby of 6 month', 'timeFrame': '6 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['renal cell carcinoma', 'ischemia', 'radio frequency ablation'], 'conditions': ['Renal Cell Carcinoma', 'Zero Ischemia']}, 'referencesModule': {'references': [{'pmid': '26905020', 'type': 'DERIVED', 'citation': 'Huang J, Zhang J, Wang Y, Kong W, Xue W, Liu D, Chen Y, Huang Y. Comparing Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Tumor Enucleation and Laparoscopic Partial Nephrectomy for Clinical T1a Renal Tumor: A Randomized Clinical Trial. J Urol. 2016 Jun;195(6):1677-83. doi: 10.1016/j.juro.2015.12.115. Epub 2016 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the feasibility and efficiency of zero ischemia laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.', 'detailedDescription': 'Warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (PN). Zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. The technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. Our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma\n* patients with normal contralateral renal function (differential renal function of \\>40% as determined by radionuclide scintigraphy)\n* patients agreeable to participate in this long-term follow-up study\n\nExclusion Criteria:\n\n* patients' aged \\>80 years\n* patients with other renal diseases\n* patients not able to tolerate the laparoscopic procedure\n* patients with previous renal surgery or history of any inflammatory conditions of the operative kidney\n* patients with the renal tumor close to the calyces"}, 'identificationModule': {'nctId': 'NCT01838720', 'briefTitle': 'Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'RenJiH-20130406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zero ischemia laparoscopic RFA assisted TE', 'description': 'RFA will be performed for 1 to 4 cycles for 4 to 12 minutes each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping.', 'interventionNames': ['Procedure: zero ischemia laparoscopic RFA assisted TE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional laparoscopic partial nephrectomy', 'description': 'Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.', 'interventionNames': ['Procedure: ischemia']}], 'interventions': [{'name': 'zero ischemia laparoscopic RFA assisted TE', 'type': 'PROCEDURE', 'otherNames': ['zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation'], 'armGroupLabels': ['zero ischemia laparoscopic RFA assisted TE']}, {'name': 'ischemia', 'type': 'PROCEDURE', 'otherNames': ['renal artery will be clamped during surgery.'], 'description': 'conventional laparoscopic partial nephrectomy', 'armGroupLabels': ['conventional laparoscopic partial nephrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yiran Huang, M.D.', 'role': 'CONTACT', 'email': 'yrhuangrenji@163.com', 'phone': '86-13501835219'}, {'name': 'Yiran Huang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'RenJi Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yiran Huang, M.D.', 'role': 'CONTACT', 'email': 'yrhuangrenji@163.com', 'phone': '86-13501835219'}], 'overallOfficials': [{'name': 'Yiran Huang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yiran Huang', 'investigatorAffiliation': 'RenJi Hospital'}}}}