Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT02252393
Status:
WITHDRAWN
Last Update Posted:
2016-11-09
First Post:
2014-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], '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': 'D001745', 'term': 'Urinary Bladder 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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'waiting on surgeon training', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-08', 'studyFirstSubmitDate': '2014-09-26', 'studyFirstSubmitQcDate': '2014-09-26', 'lastUpdatePostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': '90 days after surgery', 'description': 'Analyzed using multivariable logistical regression. Descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event reporting.'}], 'secondaryOutcomes': [{'measure': 'Time to passage of flatus', 'timeFrame': 'Up to 90 days', 'description': 'Analyzed using regression analysis.'}, {'measure': 'Analgesic requirement (narcotic use)', 'timeFrame': 'Up to 90 days', 'description': 'Analyzed using logistical regression.'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Up to 90 days', 'description': 'Analyzed using regression analysis.'}, {'measure': 'Total operating time', 'timeFrame': 'Up to completion of surgery', 'description': 'Analyzed using regression analysis.'}, {'measure': 'Estimated blood loss', 'timeFrame': 'Up to 90 days', 'description': 'Analyzed using regression analysis.'}, {'measure': 'Readmission rate', 'timeFrame': 'Up to 90 days', 'description': 'Analyzed using regression analysis.'}, {'measure': 'Quality of life assessed using the Bladder Cancer Index Questionnaire', 'timeFrame': 'Up to 5 years', 'description': 'The Cox proportional hazards model will be used. The hazard ratio (HR) and 95% confidence interval (95% CI) associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.'}, {'measure': 'Ureteral strictures', 'timeFrame': 'Up to 5 years', 'description': 'The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.'}, {'measure': 'Stromal stenosis', 'timeFrame': 'Up to 5 years', 'description': 'The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.'}, {'measure': 'Disease recurrence', 'timeFrame': 'Up to 5 years', 'description': 'The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.'}, {'measure': 'Secondary procedures', 'timeFrame': 'Up to 5 years', 'description': 'The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.'}, {'measure': 'Cumulative complication incidence', 'timeFrame': 'Up to 5 years', 'description': 'Graphically described using the Kaplan-Meier method. Descriptions and grading scales found in the NCI CTCAE version 4.0 will be utilized for adverse event reporting.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Recurrent Bladder Cancer', 'Stage 0 Bladder Cancer', 'Stage I Bladder Cancer', 'Stage II Bladder Cancer', 'Urinary Complications']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion during robotic assisted radical cystectomy in reducing complications in patients with bladder cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a new way for urine to leave the body) is performed. It is not yet known whether intracorporeal (within the body) or extracorporeal (outside of the body) urinary diversion is a better method in patients with bladder cancer undergoing robotic assisted radical cystectomy.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To compare perioperative outcomes and complications after robotic assisted radical cystectomy (RARC) with intracorporeal urinary diversion (IUD) and RARC with extracorporeal urinary diversion (EUD) in a prospective randomized fashion.\n\nSECONDARY OBJECTIVES:\n\nI. Time to passage of flatus. II. Analgesic requirement (narcotic use). III. Hospital length of stay. IV. Total operating time. V. Estimated blood loss. VI. Readmission rate. VII. Bladder Cancer Index Questionnaire. VIII. Ureteral strictures. IX. Stomal stenosis. X. Disease recurrence. XI. Secondary procedures.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients undergo RARC with IUD.\n\nARM II: Patients undergo RARC with EUD.\n\nAfter completion of study treatment, patients are followed up within 90 days and then for 2-5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Grade G1 - G3 bladder cancer\n* T stage: cTis - T2\n* N0\n* M0\n* American Society of Anesthesiologists (ASA) \\< 4\n* Informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status 2 or better\n* Hemoglobin (Hgb) \\> 8.0 g/dL\n* White blood cell (WBC) \\> 2.0 k/uL\n* Platelets \\> 50,000\n* Creatinine \\< 3.0 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) \\< 5.0 x ULN\n* Alanine transaminase (ALT) \\< 5.0 x ULN\n\nExclusion Criteria:\n\n* Patient unsuitable for or refusing radical cystectomy\n* T stage ≥ T3 (mass extending outside the bladder)\n* Gross nodal or metastatic disease at presentation (≥ N1, M1)\n* Prior pelvic radiation\n* Prior open or laparoscopic/robotic bladder or prostate surgery\n* Prior colorectal surgery or history of inflammatory bowel disease\n* Body mass index (BMI) ≥ 40\n* ECOG performance status 3 or worse\n* History of coagulopathy or bleeding disorders\n* Chronic steroid use\n* Patients with end stage renal disease (ESRD) and/or on dialysis'}, 'identificationModule': {'nctId': 'NCT02252393', 'briefTitle': 'Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy', 'orgStudyIdInfo': {'id': 'CASE7814'}, 'secondaryIdInfos': [{'id': 'NCI-2014-01530', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CASE 7814', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}, {'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (RARC with IUD)', 'description': 'Patients undergo RARC with IUD.', 'interventionNames': ['Procedure: robot-assisted laparoscopic surgery', 'Other: intraoperative complication management/prevention', 'Other: quality-of-life assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (RARC with EUD)', 'description': 'Patients undergo RARC with EUD.', 'interventionNames': ['Procedure: robot-assisted laparoscopic surgery', 'Other: intraoperative complication management/prevention', 'Other: quality-of-life assessment']}], 'interventions': [{'name': 'robot-assisted laparoscopic surgery', 'type': 'PROCEDURE', 'description': 'Undergo RARC with IUD', 'armGroupLabels': ['Arm I (RARC with IUD)']}, {'name': 'robot-assisted laparoscopic surgery', 'type': 'PROCEDURE', 'description': 'Undergo RARC with EUD', 'armGroupLabels': ['Arm II (RARC with EUD)']}, {'name': 'intraoperative complication management/prevention', 'type': 'OTHER', 'description': 'Undergo RARC with IUD', 'armGroupLabels': ['Arm I (RARC with IUD)']}, {'name': 'intraoperative complication management/prevention', 'type': 'OTHER', 'description': 'Undergo RARC with EUD', 'armGroupLabels': ['Arm II (RARC with EUD)']}, {'name': 'quality-of-life assessment', 'type': 'OTHER', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (RARC with IUD)', 'Arm II (RARC with EUD)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jihad Kaouk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}