Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-07 @ 8:41 AM
Study NCT ID:
NCT03163134
Status:
TERMINATED
Last Update Posted:
2017-08-16
First Post:
2017-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lumbar Drain After Endoscopic Surgery of the Skull Base
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002558', 'term': 'Cerebrospinal Fluid Otorrhea'}], 'ancestors': [{'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'valappilb2@upmc.edu', 'phone': '412.864.1744', 'title': 'Benita Valappil', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Three times a year', 'eventGroups': [{'id': 'EG000', 'title': 'No Lumbar Drain Group', 'description': 'Group of patients that did not receive a lumbar drain after surgery', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lumbar Drain Group', 'description': 'Group of patients that received a lumbar drain after surgery\n\nLumbar Drain', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Cerebrospinal Fluid (CSF) Leak', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Lumbar Drain Group', 'description': 'Group of patients that did not receive a lumbar drain after surgery.'}, {'id': 'OG001', 'title': 'Lumbar Drain Group', 'description': 'Group of patients that received a lumbar drain after surgery.\n\nLumbar Drain'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1month', 'description': 'Determine the rate of CSF leak in endoscopic endonasal approach (EEA) patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Lumbar Drain Group', 'description': 'Group of patients that did not receive a lumbar drain after surgery.'}, {'id': 'OG001', 'title': 'Lumbar Drain Group', 'description': 'Group of patients that received a lumbar drain after surgery.\n\nLumbar Drain'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.577', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Determine the rate of any postoperative complications related to Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Meningitis and Respiratory infections in EEA patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Lumbar Drain Group', 'description': 'Group of patients that did not receive a lumbar drain after surgery'}, {'id': 'FG001', 'title': 'Lumbar Drain Group', 'description': 'Group of patients that received a lumbar drain after surgery\n\nLumbar Drain'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All adult patients undergoing endoscopic endonasal approach (EEA) at the Center for Cranial Base Surgery of the University of Pittsburgh Medical Center from February 2011 to April 2015 were evaluated for enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Lumbar Drain Group', 'description': 'Group of patients that did not receive a lumbar drain after surgery.'}, {'id': 'BG001', 'title': 'Lumbar Drain Group', 'description': 'Group of patients that received a lumbar drain after surgery.\n\nLumbar Drain'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '15.11', 'groupId': 'BG000'}, {'value': '51', 'spread': '15.49', 'groupId': 'BG001'}, {'value': '52', 'spread': '15.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'whyStopped': 'Due to the fact data results were statistically significant among the two groups', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-17', 'studyFirstSubmitDate': '2017-05-19', 'resultsFirstSubmitDate': '2017-05-26', 'studyFirstSubmitQcDate': '2017-05-19', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-17', 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Cerebrospinal Fluid (CSF) Leak', 'timeFrame': '1month', 'description': 'Determine the rate of CSF leak in endoscopic endonasal approach (EEA) patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Postoperative Complications', 'timeFrame': '1 year', 'description': 'Determine the rate of any postoperative complications related to Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Meningitis and Respiratory infections in EEA patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Lumbar Drain, CSF Leak'], 'conditions': ['Quality of Life']}, 'referencesModule': {'references': [{'pmid': '30485224', 'type': 'DERIVED', 'citation': 'Zwagerman NT, Wang EW, Shin SS, Chang YF, Fernandez-Miranda JC, Snyderman CH, Gardner PA. Does lumbar drainage reduce postoperative cerebrospinal fluid leak after endoscopic endonasal skull base surgery? A prospective, randomized controlled trial. J Neurosurg. 2018 Oct 19;131(4):1172-1178. doi: 10.3171/2018.4.JNS172447. Print 2019 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'The overall purpose of this study was to assess the necessity of lumbar drain placement after endoscopic endonasal approach (EEA) surgery in reducing cerebrospinal fluid (CSF) leak postoperatively and promote a standardization of its use.', 'detailedDescription': 'In the past, reconstructions were performed using fat grafts or fascia lata for EEA surgery. Considerably high postoperative CSF leaks were reported and were a major cause of concern due CSF fistula increasing risk of infection. Since external lumbar drain can lower CSF pressure and is believed to prevent post operative CSF leak, it was used commonly after EEA. With improvements in EEA skull base reconstructions using a nasal septal flap in the recent years, postoperative CSF leaks have been reported in much lower rates. With this improvement in reconstruction techniques, the use of lumbar drain may not be necessary as it may not significantly lower the risk of CSF leak further. In this prospective randomized study, we will randomize subjects at high risk for CSF leak to either receive a prophylactic lumbar drain or to not receive a prophylactic lumbar drain and compare the rate of CSF leaks and other complications in the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Patients undergoing EEA for resection of brain tumors\n* Dural defect greater than 1cm\n* Extensive arachnoid dissection\n* Dissection into a ventricle or cistern\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Spina Bifida'}, 'identificationModule': {'nctId': 'NCT03163134', 'briefTitle': 'Lumbar Drain After Endoscopic Surgery of the Skull Base', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Lumbar Drain After Endoscopic Surgery of the Skull Base', 'orgStudyIdInfo': {'id': 'PRO10030258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Lumbar Drain Group', 'description': 'Group of patients that did not receive a lumbar drain after surgery'}, {'type': 'EXPERIMENTAL', 'label': 'Lumbar Drain Group', 'description': 'Group of patients that received a lumbar drain after surgery', 'interventionNames': ['Device: Lumbar Drain']}], 'interventions': [{'name': 'Lumbar Drain', 'type': 'DEVICE', 'armGroupLabels': ['Lumbar Drain Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Paul Gardner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Paul Gardner', 'investigatorAffiliation': 'University of Pittsburgh'}}}}