Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-01-02 @ 1:15 AM
Study NCT ID:
NCT05939856
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2023-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lymph Node Dissection Before or After Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2023-06-06', 'studyFirstSubmitQcDate': '2023-07-03', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intraoperative complications rate', 'timeFrame': 'At the end of the surgery (after the completion of skin closure and wound dressing)', 'description': 'Intraoperative complications rate'}, {'measure': 'Positive surgical margin rate', 'timeFrame': 'When pathology report is available (on average, the pathology report is available within 14 days after the surgery)', 'description': 'Positive surgical margin rate'}, {'measure': 'Ureters clamping time', 'timeFrame': 'At the end of the surgery (after the completion of skin closure and wound dressing)', 'description': 'Ureters clamping time'}, {'measure': 'Postoperative estimated glomerular filtration rate (eGFR)', 'timeFrame': 'Within 7 days after the surgery', 'description': 'eGFR on postoperative day 1 and day 4-7'}, {'measure': 'Complications severity and type', 'timeFrame': 'Within 30 days after the surgery', 'description': 'Severity and type of complications'}], 'primaryOutcomes': [{'measure': 'Early complications rate', 'timeFrame': 'Within 30 days after the surgery', 'description': 'Complications rate within 30 postoperative days'}], 'secondaryOutcomes': [{'measure': 'Lymph node yield', 'timeFrame': 'When pathology report is available (on average, the pathology report is available within 14 days after the surgery)', 'description': 'Number of lymph nodes removed'}, {'measure': 'Operative time', 'timeFrame': 'At the end of the surgery (after the completion of skin closure and wound dressing)', 'description': 'Total operative time, bladder resection time, lymph node dissection time'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bladder Cancer', 'Muscle-invasive bladder cancer', 'Radical cystectomy', 'Lymph node dissection'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare different ways of performing surgery for bladder cancer. Specifically, the goal is to determine whether it is better to remove the lymph nodes before removing the bladder or after removing the bladder during radical cystectomy.\n\nThe study aims to answer two main questions:\n\n* Does the order of surgical steps during radical cystectomy affect the occurrence of complications after surgery?\n* Does the order of surgical steps during radical cystectomy impact the duration of the operation and the number of lymph nodes removed?\n\nParticipants in the study will be randomly assigned to one of two groups. One group will undergo lymph node removal before bladder resection, while the other group will have lymph node removal after bladder resection during radical cystectomy.\n\nThroughout their hospital stay and for 30 days following the operation, participants will be closely monitored for various factors including operative details, pathology results, and any complications that may arise.', 'detailedDescription': 'Lymph node dissection (LND) is an integral part of radical cystectomy (RC) for bladder cancer. LND provides important diagnostic and prognostic information, and according to most studies, is associated with therapeutic benefit. The optimal extent and template for LND in bladder cancer remains to be established. Currently, there are no specific recommendations regarding the sequence of lymph nodes removal and bladder resection during radical cystectomy, and the decision is based mainly on individual surgeon preference.\n\nThe aim of the LBOAC pilot randomized trial is to evaluate the difference in intraoperative parameters and postoperative outcomes between patients undergoing LND before bladder resection during RC and those undergoing LND after bladder resection during RC.\n\nLBOAC is a pilot randomized controlled trial with two parallel groups. The primary objective of the trial is the comparison of complication rate within 30 postoperative days. Secondary objectives of LBOAC include comparing lymph node yield and operative time between the two groups.\n\nData for will be collected using electronic case report forms (eCRFs) at baseline and within 30 days after the surgery.\n\nThis pilot study is designed to test feasibility of, to support the refinements of the protocol and to aid in sample calculation that can be used for larger scale trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing radical cystectomy for bladder cancer in the Department of Urology University Hospital in Krakow\n\nExclusion Criteria:\n\n* Previous pelvic lymph node dissection'}, 'identificationModule': {'nctId': 'NCT05939856', 'acronym': 'LBOACP', 'briefTitle': 'Lymph Node Dissection Before or After Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Lymph Node Dissection Before or After Cystectomy - Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LBOACPUJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1 Lymph node dissection before bladder resection', 'description': 'Lymph node dissection will be performed before bladder resection during radical cystectomy', 'interventionNames': ['Other: Lymph node dissection before bladder resection']}, {'type': 'OTHER', 'label': '2 Lymph node dissection after bladder resection', 'description': 'Lymph node dissection will be performed after bladder resection during radical cystectomy', 'interventionNames': ['Other: Lymph node dissection after bladder resection']}], 'interventions': [{'name': 'Lymph node dissection before bladder resection', 'type': 'OTHER', 'description': 'Lymph node dissection before bladder resection', 'armGroupLabels': ['1 Lymph node dissection before bladder resection']}, {'name': 'Lymph node dissection after bladder resection', 'type': 'OTHER', 'description': 'Lymph node dissection after bladder resection', 'armGroupLabels': ['2 Lymph node dissection after bladder resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30-688', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Department of Urology, University Hospital, Jagiellonian University', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Anna K. Czech', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna K. Czech, MD', 'investigatorAffiliation': 'Jagiellonian University'}}}}