Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-24 @ 7:34 AM
Study NCT ID:
NCT01607866
Status:
WITHDRAWN
Last Update Posted:
2016-11-08
First Post:
2012-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quadrant Versus Superficial Parotidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of enrollment of eligible patients for randomization.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-07', 'studyFirstSubmitDate': '2012-05-24', 'studyFirstSubmitQcDate': '2012-05-25', 'lastUpdatePostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with permanent facial nerve palsy', 'timeFrame': 'measured six months after the date of surgery', 'description': 'using clinical neurological examination'}], 'secondaryOutcomes': [{'measure': 'Number of participants with temporary facial nerve palsy', 'timeFrame': 'Measured at one day and at three months from the date of surgery.', 'description': 'using clinical neurological examination'}, {'measure': 'Operative time in minutes', 'timeFrame': 'Measured at the time of surgery', 'description': 'Median and range of operative time per intervention arm will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pleomorphic Adenoma of the Parotid Gland']}, 'referencesModule': {'references': [{'pmid': '21417969', 'type': 'BACKGROUND', 'citation': 'Uyar Y, Caglak F, Keles B, Yildirim G, Salturk Z. Extracapsular dissection versus superficial parotidectomy in pleomorphic adenomas of the parotid gland. Kulak Burun Bogaz Ihtis Derg. 2011 Mar-Apr;21(2):76-9. doi: 10.5606/kbbihtisas.2011.003.'}, {'pmid': '1328626', 'type': 'BACKGROUND', 'citation': 'Prichard AJ, Barton RP, Narula AA. Complications of superficial parotidectomy versus extracapsular lumpectomy in the treatment of benign parotid lesions. J R Coll Surg Edinb. 1992 Jun;37(3):155-8.'}]}, 'descriptionModule': {'briefSummary': 'The most common benign tumor of the parotid gland is the so called pleomorphic adenoma. Although benign, this tumor may recur after surgical removal due to tumor cells left behind during the surgical operation. Thus, pleomorphic adenomas have been treated with wide resection similar to malignant tumors. This extensive surgery often leads to injury to the motor nerves responsible for facial expression and eye protection. The investigators propose less extensive surgery which should be thorough enough to prevent tumor recurrence while keeping the facial nerve out of risk.', 'detailedDescription': 'Pleomorphic adenoma is notorious of its propensity to local recurrence due to the microscopic extracapsular extension of the tumor. Superficial parotidectomy (SP) is the standard treatment. Extracapsular dissection (ED) has been proposed to minimize the risk of facial nerve palsy. However, the oncologic safety of ED is controversial in the literature. We propose quadrant parotidectomy (QP) which is less radical than SP and less conservative than ED. QP entails dissection overlying one primary division of the facial nerve leaving the other division undisturbed while the resection safety margin is still generous.\n\nSurgery for pleomorphic adenoma is a compromise between radicality and facial nerve morbidity. Risk of local recurrence is imprecisely described in the literature and is universally regarded as infrequent and remote. Many studies did not report recurrent cases. Thus, Facial nerve injury is the main concern of parotid surgeons and is considered the primary end point of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with pleomorphic adenoma of the parotid gland with Cytology- proven diagnosis\n\nExclusion Criteria:\n\n* Collagen diseases\n* Previous parotid surgery\n* Previous facial nerve palsy\n* Neuromuscular diseases affecting the face\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT01607866', 'briefTitle': 'Quadrant Versus Superficial Parotidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma', 'orgStudyIdInfo': {'id': 'R/89'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadrant parotidectomy', 'description': 'Patients in this arm will receive excision of the parotid gland quadrant harboring the tumor', 'interventionNames': ['Procedure: Quadrant parotidectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Superficial parotidectomy', 'description': 'Patients in this group will receive superficial parotidectomy', 'interventionNames': ['Procedure: Superficial parotidectomy']}], 'interventions': [{'name': 'Quadrant parotidectomy', 'type': 'PROCEDURE', 'description': 'Excision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland', 'armGroupLabels': ['Quadrant parotidectomy']}, {'name': 'Superficial parotidectomy', 'type': 'PROCEDURE', 'description': 'Excision of the whole superficial lobe of the parotid gland', 'armGroupLabels': ['Superficial parotidectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura University Cancer Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Osama Hussein, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}, {'name': 'Adel Denewer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Osama Hussein', 'investigatorAffiliation': 'Mansoura University'}}}}