Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-31 @ 2:52 AM
Study NCT ID:
NCT04213157
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2019-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Partial Nephrectomy for cT1 Tumors
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'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}], 'ancestors': [{'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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-27', 'studyFirstSubmitDate': '2019-12-25', 'studyFirstSubmitQcDate': '2019-12-25', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operation time', 'timeFrame': 'at the end of the surgery', 'description': 'time from onset to complete of surgery'}, {'measure': 'Blood loss', 'timeFrame': 'at the end of the surgery', 'description': 'amount of bleeding during surgery (mL)'}, {'measure': 'warm ischemia time', 'timeFrame': 'at the and of the surgery', 'description': 'The clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy'}, {'measure': 'intraoperative complication', 'timeFrame': 'at the end of the surgery', 'description': 'abnormal problmes that may be seen during surgery'}, {'measure': 'Postoperative complication', 'timeFrame': 'up to 3 months', 'description': 'abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up'}, {'measure': 'functional outcomes', 'timeFrame': 'up to 1 year postoperatively', 'description': 'serum creatinine level and estimated glomerular filtration rate'}, {'measure': 'surigcal margin status', 'timeFrame': 'up to 1 month postoperatively', 'description': 'presence or absence of tumors at the surgical margin'}, {'measure': 'Relative decrease in renal function', 'timeFrame': 'up to 1 year postoperatively', 'description': 'Comparison of preoperative and postoperative renal functions according to numerical and percentile values'}, {'measure': 'CKD stage upgrading', 'timeFrame': 'up to 1 year postoperatively', 'description': 'evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages'}, {'measure': 'Oncological outomes', 'timeFrame': 'up to the last clinical control (months)', 'description': 'Presence or absence of local and/or distal tumor recurrence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic partial nephrectomy', 'Trifecta', 'Pentafecta', 'Outcomes'], 'conditions': ['Renal Cancer', 'Renal Neoplasm', 'Renal Cell Carcinoma', 'Surgery', 'Surgery--Complications', 'Renal Functional Abnormality', 'Oncology', 'Oncology Problem', 'Kidney Ischemia', 'Kidney Injury', 'Urologic Neoplasms', 'Urologic Cancer', 'Kidney Neoplasms']}, 'referencesModule': {'references': [{'pmid': '23937616', 'type': 'RESULT', 'citation': 'Porpiglia F, Bertolo R, Amparore D, Fiori C. Margins, ischaemia and complications rate after laparoscopic partial nephrectomy: impact of learning curve and tumour anatomical characteristics. BJU Int. 2013 Dec;112(8):1125-32. doi: 10.1111/bju.12317. Epub 2013 Aug 13.'}, {'pmid': '24013181', 'type': 'RESULT', 'citation': 'Minervini A, Siena G, Antonelli A, Bianchi G, Bocciardi AM, Cosciani Cunico S, Ficarra V, Fiori C, Fusco F, Mari A, Martorana G, Medica M, Mirone V, Morgia G, Porpiglia F, Rocco F, Rovereto B, Schiavina R, Simeone C, Terrone C, Volpe A, Carini M, Serni S; Members of the RECORd Project-LUNA Foundation. Open versus laparoscopic partial nephrectomy for clinical T1a renal masses: a matched-pair comparison of 280 patients with TRIFECTA outcomes (RECORd Project). World J Urol. 2014 Feb;32(1):257-63. doi: 10.1007/s00345-013-1155-7. Epub 2013 Sep 7.'}, {'pmid': '26251228', 'type': 'RESULT', 'citation': 'Osaka K, Makiyama K, Nakaigawa N, Yao M. Predictors of trifecta outcomes in laparoscopic partial nephrectomy for clinical T1a renal masses. Int J Urol. 2015 Nov;22(11):1000-5. doi: 10.1111/iju.12893. Epub 2015 Aug 6.'}, {'pmid': '18632142', 'type': 'RESULT', 'citation': 'Rais-Bahrami S, Romero FR, Lima GC, Kohanim S, Permpongkosol S, Trock BJ, Jarrett TW, Kavoussi LR. Elective laparoscopic partial nephrectomy in patients with tumors >4 cm. Urology. 2008 Sep;72(3):580-3. doi: 10.1016/j.urology.2008.05.027. Epub 2008 Jul 16.'}, {'pmid': '32967451', 'type': 'DERIVED', 'citation': 'Mercimek MN, Ozden E, Gulsen M, Yakupoglu YK, Bostanci Y, Sarikaya S. Which Is the Best Predictor to Achieve Trifecta in Patients Undergoing Elective Laparoscopic Partial Nephrectomy with Global Hilar Clamping? Comparative Analysis in Patients with Clinical T1a and T1b Renal Tumors. J Endourol. 2021 May;35(5):615-622. doi: 10.1089/end.2020.0758. Epub 2020 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate trifecta and pentafecta outcomes for laparoscopic partial nephrectomy (LNP) in patients with clinical T1N0M0 renal tumor.', 'detailedDescription': 'From November 2009 to August 2018 a total of 292 patients who underwent LPN by global ischemia were included in the study. The patients were allocated into two groups according to the tumor size; T1a (≤ 40 mm, n=215), T1b (41-70 mm, n=77). Demographics features, clinical tumor characteristics, intraoperative and postoperative outcomes were analyzed. A negative surgical margin, warm ischemia time (WIT) \\< 20 min and no postoperative complications (Clavien-Dindo ≥ grade 3) were accepted to achieve the trifecta outcomes. Pentafecta has defined as trifecta criteria plus \\>90% preservation of estimated glomerular filtration rate (eGFR) and no stage upgrade of chronic kidney disease 12 months after LPN. Univariable and multivariable analysis were used to identify factors predicting trifecta and pentafecta achievement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Two hundred ninety-two patients who have a follow-up at least 12 months were included in the study. Those were allocated into two groups according to radiological tumor size; 215 patients with tumor size ≤ 40 mm were included in group T1a and 77 patients with tumor size 41-70 mm were included in group T1b.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Functioning contraleteral kidney\n* Patients with complete data\n* Patients with single renal tumor on the effected side\n* Patients who approved the written consent form\n\nExclusion Criteria:\n\n* The patients with bilateral renal tumors (n=8, 16 LPNs)\n* solitary kidney (n=8)\n* horseshoe kidney (n=4)\n* pelvic ectopic kidney (n=2)\n* graft kidney (n=2)\n* those with multiple renal tumors in a single kidney (n=3) or with \\> 7 cm renal tumor (n=6)\n* Patients who were operated on for colon cancer (n=4), prostate cancer (n=2), endometrial cancer (n=1) or adrenal mass (n=2) within the first year after LPN'}, 'identificationModule': {'nctId': 'NCT04213157', 'briefTitle': 'Laparoscopic Partial Nephrectomy for cT1 Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Samsun Liv Hospital'}, 'officialTitle': 'Evaluation Trifecta and Pentafecta Outcomes of Patients Underwent Laparoscopic Partial Nephrectomy for cT1 Renal Tumor', 'orgStudyIdInfo': {'id': 'OMU KAEK 2019/241'}}, 'contactsLocationsModule': {'locations': [{'zip': '55020', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Liv hospital samsun', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'zip': '55030', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayıs University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Saban Sarıkaya, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Ondokuz Mayıs University'}, {'name': 'Ender Ozden, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ondokuz Mayıs University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not yet known if there will be a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsun Liv Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mehmet Necmettin Mercimek', 'investigatorAffiliation': 'Samsun Liv Hospital'}}}}