Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-25 @ 5:03 PM
Study NCT ID:
NCT03515603
Status:
TERMINATED
Last Update Posted:
2023-05-17
First Post:
2018-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endocrine Outcome of Surgery for Pituitary Adenoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'only surgeon knows the used technique, endocrinologist, patient and all involved medical staff is blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': 'Inadequate recruiting', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-14', 'studyFirstSubmitDate': '2018-04-14', 'studyFirstSubmitQcDate': '2018-05-02', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endocrine function', 'timeFrame': '1 year after surgery', 'description': 'Testing of pituitary function with insulin-hypoglycemic test, results will be dichotomized as satisfactory or not satisfactory. Satisfactory outcome is defined, if pituitary function improves or is stable, if compared to preoperative testing.'}], 'secondaryOutcomes': [{'measure': 'Extent of resection', 'timeFrame': 'tumor volume before the surgery, 3 months after surgery', 'description': 'Volumetric analysis of tumor volume before the surgery, intraoperatively and 3 months after surgery will be performed. Gross total resection is defined as no tumor present in gadolinium enhanced T1 sequences'}, {'measure': 'Quality of Life, EQ-5D', 'timeFrame': '3 months and 1 year after surgery', 'description': 'EQ-5D will be evaluated before surgery, after the surgery in 3 months and after 1 year.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pituitary Adenoma']}, 'referencesModule': {'references': [{'pmid': '39852769', 'type': 'DERIVED', 'citation': 'Pala A, Grubel N, Mayer B, Becker R, Sommer F, Schmitz B, Etzrodt-Walter G, Wirtz CR, Hlavac M. Endocrine Outcome and Quality of Life After Transsphenoidal Resection of Pituitary Adenoma-A Prospective Randomized Single-Blinded Study Comparing Endoscopic Versus Microscopic Resection. Neurol Int. 2025 Jan 10;17(1):5. doi: 10.3390/neurolint17010005.'}]}, 'descriptionModule': {'briefSummary': 'Prospective and randomized compare between microsurgical and endoscopic transsphenoidal MRI assisted resection of pituitary adenomas.', 'detailedDescription': 'The main aim of the study is to compare microsurgical and endoscopic transsphenoidal surgery and to determine endocrine outcome. Secondary extent of resection and quality of life will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected symptomatic or progressively growing pituitary adenoma\n* Informed consent\n\nExclusion Criteria:\n\n* Prolactinoma\n* No follow-up possible\n* Emergency surgery without informed consent or without intraoperative MRI'}, 'identificationModule': {'nctId': 'NCT03515603', 'briefTitle': 'Endocrine Outcome of Surgery for Pituitary Adenoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Compare Between Endoscopic and Microsurgical Transsphenoidal Resection of Pituitary Adenomas With Intraoperative MRI', 'orgStudyIdInfo': {'id': 'EndOSPA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'microsurgical technique', 'interventionNames': ['Procedure: Microsurgical resection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'endoscopic technique', 'interventionNames': ['Procedure: Endoscopic resection']}], 'interventions': [{'name': 'Endoscopic resection', 'type': 'PROCEDURE', 'description': 'Transsphenoidal endoscopic resection of pituitary adenoma', 'armGroupLabels': ['endoscopic technique']}, {'name': 'Microsurgical resection', 'type': 'PROCEDURE', 'description': 'Transsphenoidal microsurgical resection of pituitary adenoma', 'armGroupLabels': ['microsurgical technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89312', 'city': 'Günzburg', 'country': 'Germany', 'facility': 'Department of Neurosurgery', 'geoPoint': {'lat': 48.45599, 'lon': 10.27695}}], 'overallOfficials': [{'name': 'Andrej Pala, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ulm, Department of Neurosurgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andrej Pala', 'investigatorAffiliation': 'University of Ulm'}}}}