Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT02326558
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2014-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma
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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-03', 'studyFirstSubmitDate': '2014-12-17', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'absolute change in glomerular filtration rate (GFR) of the affected kidney', 'timeFrame': 'baseline, 3 months and 12 months', 'description': 'measured by renal scintigraphy'}], 'secondaryOutcomes': [{'measure': 'absolute change in eGFR of the affected kidney', 'timeFrame': 'baseline, 3 months, 6 months and 12 months'}, {'measure': 'absolute change in total GFR', 'timeFrame': 'baseline and 6 months', 'description': 'measured by renal scintigraphy'}, {'measure': 'blood loss', 'timeFrame': 'during surgery'}, {'measure': 'operation time', 'timeFrame': 'during surgery'}, {'measure': 'surgical margin', 'timeFrame': '1 month', 'description': 'assessed according to the pathology report of the operation specimen'}, {'measure': 'postoperative complications', 'timeFrame': 'up to 6 months', 'description': 'number of participants with postoperative complications graded by Clavien- Dindo system'}, {'measure': 'progression-free survival', 'timeFrame': '12 months'}, {'measure': 'local recurrence', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['zero ischemia', 'microwave', 'ablation', 'enucleation', 'renal cell carcinoma'], 'conditions': ['Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.', 'detailedDescription': 'Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with 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* exophytic cancer\n* distance from the hilar renal vessels and urinary collecting system \\>= 1cm\n* patients with normal contralateral renal function (differential renal function of \\>40% as determined by renal scintigraphy)\n* patients giving consent to the participation in the current clinical trial\n\nExclusion Criteria:\n\n* patients with a history of other renal diseases, such as urinary lithiasis\n* patients with a history of renal surgery'}, 'identificationModule': {'nctId': 'NCT02326558', 'briefTitle': 'Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Comparison of Zero Ischemia Laparoscopic Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'RenJiH-URO-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'microwave enucleation', 'description': 'zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor', 'interventionNames': ['Procedure: laparoscopic microwave ablation-assisted enucleation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic partial nephrectomy', 'description': 'conventional laparoscopic partial nephrectomy with clamping of the renal artery', 'interventionNames': ['Procedure: conventional laparoscopic partial nephrectomy']}], 'interventions': [{'name': 'laparoscopic microwave ablation-assisted enucleation', 'type': 'PROCEDURE', 'armGroupLabels': ['microwave enucleation']}, {'name': 'conventional laparoscopic partial nephrectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['laparoscopic partial nephrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Yi-Ran Huang, M.D.', 'role': 'STUDY_CHAIR', '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': 'Chef of Urology', 'investigatorFullName': 'Huang Yi-Ran', 'investigatorAffiliation': 'RenJi Hospital'}}}}