Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-29 @ 3:01 PM
Study NCT ID:
NCT04933604
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2021-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LPN in Patients With High-complex Renal 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': 78}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-13', 'studyFirstSubmitDate': '2021-05-31', 'studyFirstSubmitQcDate': '2021-06-13', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', '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': 'Postoperative complication', 'timeFrame': 'up to 3 months postoperatively', 'description': 'abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up'}, {'measure': 'functional outcomes', 'timeFrame': '1 year after the surgery', 'description': 'serum creatinine level (mg /dL) and estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)'}, {'measure': 'surigcal margin status', 'timeFrame': 'postoperative follow-up, through study completion, an average of 1 year', 'description': 'presence or absence of tumors at the surgical margin'}, {'measure': 'CKD stage upgrading', 'timeFrame': 'postoperative follow-up, through study completion, an average of 1 year', 'description': 'evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages'}, {'measure': 'Oncological outomes', 'timeFrame': 'postoperative follow-up, through study completion, an average of 1 year', 'description': 'Presence or absence of local and/or distal tumor recurrence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopy', 'nephrometry score', 'partial nephrectomy', 'propensity score matching', 'radical nephrectomy'], 'conditions': ['Renal Cancer', 'Renal Neoplasm', 'Renal Cell Carcinoma', 'Surgery', 'Oncology', 'Kidney Ischemia', 'Kidney Injury', 'Urologic Neoplasms', 'Urologic Cancer', 'Kidney Neoplasms']}, 'referencesModule': {'references': [{'pmid': '27988238', 'type': 'RESULT', 'citation': 'Kim SP, Campbell SC, Gill I, Lane BR, Van Poppel H, Smaldone MC, Volpe A, Kutikov A. Collaborative Review of Risk Benefit Trade-offs Between Partial and Radical Nephrectomy in the Management of Anatomically Complex Renal Masses. Eur Urol. 2017 Jul;72(1):64-75. doi: 10.1016/j.eururo.2016.11.038. Epub 2016 Dec 14.'}, {'pmid': '27614693', 'type': 'RESULT', 'citation': 'Mir MC, Derweesh I, Porpiglia F, Zargar H, Mottrie A, Autorino R. Partial Nephrectomy Versus Radical Nephrectomy for Clinical T1b and T2 Renal Tumors: A Systematic Review and Meta-analysis of Comparative Studies. Eur Urol. 2017 Apr;71(4):606-617. doi: 10.1016/j.eururo.2016.08.060. Epub 2016 Sep 7.'}, {'pmid': '31677114', 'type': 'RESULT', 'citation': 'Yang F, Zhou Q, Xing N. Comparison of survival and renal function between partial and radical laparoscopic nephrectomy for T1b renal cell carcinoma. J Cancer Res Clin Oncol. 2020 Jan;146(1):261-272. doi: 10.1007/s00432-019-03058-z. Epub 2019 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the rationale for LPN in patients with high-complexity renal tumors in terms of oncologic and functional outcomes.', 'detailedDescription': 'From November 2009 to October 2018, 399 patients underwent LPN and 307 patients to laparoscopic radical nephrectomy (LRN). 41 patients with RENAL score ≥ 10 enrolled in LPN and 265 patients to the LRN group. Propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (DM), hypertension (HT), coronary artery disease (CAD), and final tumor pathology of RCC) was used to reduce selection bias. Functional and oncological outcomes were compared between the two groups. After propensity score analysis, 39 patients in the LRN group were matched with 39 in the LPN group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'From November 2009 to October 2018, 399 patients underwent LPN and 307 patients to laparoscopic radical nephrectomy (LRN). 41 patients with RENAL score ≥ 10 enrolled in LPN and 265 patients to the LRN group. Propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (DM), hypertension (HT), coronary artery disease (CAD) and final tumor pathology of RCC) was used to reduce selection bias. Functional and oncological outcomes were compared between the two groups. After propensity score analysis, 39 patients in the LRN group were matched with 39 in the LPN group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\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* Patients who not approved the written consent form\n* Patients with incomplete data\n* Patients with low or mild complexity renal tumors'}, 'identificationModule': {'nctId': 'NCT04933604', 'briefTitle': 'LPN in Patients With High-complex Renal Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Samsun Liv Hospital'}, 'officialTitle': 'Comparison of Laparoscopic Partial Nephrectomy Versus Laparoscopic Radical Nephrectomy in Patients With High-Complexity Renal Tumors: A Propensity Score Matched Analysis', 'orgStudyIdInfo': {'id': 'OMU KAEK 11.07.2019/538'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LPN group', 'description': '39 patients with high complexity renal tumors who underwent laparoscopic partial nephrectomy', 'interventionNames': ['Procedure: laparoscopic partial nephrectomy']}, {'label': 'LRN group', 'description': '39 patients with high complexity renal tumors who underwent laparoscopic radical nephrectomy', 'interventionNames': ['Procedure: Laparoscopic radical nephrectomy']}], 'interventions': [{'name': 'laparoscopic partial nephrectomy', 'type': 'PROCEDURE', 'description': 'Nephron sparing minimally invasive surgery', 'armGroupLabels': ['LPN group']}, {'name': 'Laparoscopic radical nephrectomy', 'type': 'PROCEDURE', 'description': 'Completely removal of kidney by using laparoscopic surgery', 'armGroupLabels': ['LRN group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55020', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayıs University, Department of Urology', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Ender Ozden, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ondokuz Mayıs Üniversitesi, Tıp Fakültesi, Üroloji Anabilim dalı'}, {'name': 'Saban Sarıkaya, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ondokuz Mayıs University, Faculty of Medicine, Department of Urology'}, {'name': 'Mehmet Mercimek, MD, FEBU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liv Hospital Samsun, Department of Urology'}, {'name': 'Yakup Bostancı, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ondokuz Mayıs University, Faculty of Medicine, Department of Urology'}, {'name': 'Murat Gulsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsun Gazi State Hospital, Departmen of Urology, Samsun, Turkey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}