Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06156020
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2023-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome Analysis of Endoscopic Resection of Pituitary Adenomas
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2023-11-15', 'studyFirstSubmitQcDate': '2023-11-24', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual field', 'timeFrame': '6 months', 'description': 'The postoperative visual field will be assessed with standard visual perimetry and compared with preoperative measurements.'}, {'measure': 'Diabetes insipidus', 'timeFrame': '6 months', 'description': "Postoperatively, the patient's urine output and urine specific gravity will be measured to determine if the patient had diabetes insipidus. If the patient had diabetes insipidus, the duration of the diabetes insipidus will be recorded."}, {'measure': 'Cortisol level', 'timeFrame': '6 months', 'description': 'Postoperative serum cortisol level will be measured and compared to preoperative levels.'}, {'measure': 'Thyroid hormone level', 'timeFrame': '6 months', 'description': 'Postoperative serum TSH and free T4 level will be measured and compared to preoperative levels.'}, {'measure': 'Prolactin level', 'timeFrame': '6 months', 'description': 'Postoperative serum prolactin level will be measured and compared to preoperative levels.'}, {'measure': 'IGF-1 level', 'timeFrame': '6 months', 'description': 'Postoperative serum IGF-1 level will be measured and compared to preoperative levels.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pituitary adenoma'], 'conditions': ['Pituitary Adenoma']}, 'referencesModule': {'references': [{'pmid': '38963694', 'type': 'DERIVED', 'citation': 'Wong CE, Chen PW, Hsu HJ, Cheng SY, Fan CC, Chen YC, Chiu YP, Lee JS, Liang SF. Collaborative Human-Computer Vision Operative Video Analysis Algorithm for Analyzing Surgical Fluency and Surgical Interruptions in Endonasal Endoscopic Pituitary Surgery: Cohort Study. J Med Internet Res. 2024 Jul 4;26:e56127. doi: 10.2196/56127.'}]}, 'descriptionModule': {'briefSummary': "The goal of this prospective study is to learn about the operative outcomes in patients with pituitary adenoma who receive endoscopic resection.\n\nThe main question it aims to answer is:\n\n• What are the outcomes of patient following endoscopic resection? including visual, hormonal, survival, and functional outcomes.\n\nParticipants' data including clinical history, laboratory data, radiographic images, intraoperative videos will be evaluated and analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* Pathological diagnosis of pituitary adenoma\n* Underwent endoscopic endonasal resection\n\nExclusion Criteria:\n\n* Age \\< 18 or \\> 80 years\n* Non-pituitary adenoma pathologies\n* Underwent non-endoscopic surgery'}, 'identificationModule': {'nctId': 'NCT06156020', 'briefTitle': 'Outcome Analysis of Endoscopic Resection of Pituitary Adenomas', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Analysis of Operative Outcomes Following Endoscopic Resection of Pituitary Adenomas', 'orgStudyIdInfo': {'id': 'B-ER-112-452'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Endoscopic endonasal surgery', 'description': 'Patients who received endoscopic endonasal resection of pituitary adenomas', 'interventionNames': ['Procedure: Endoscopic endonasal surgery']}], 'interventions': [{'name': 'Endoscopic endonasal surgery', 'type': 'PROCEDURE', 'description': 'Endoscopic endonasal transsphenoidal approach for resection of pituitary adenomas', 'armGroupLabels': ['Endoscopic endonasal surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '704', 'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jung-Shun Lee', 'role': 'CONTACT'}], 'facility': 'National Cheng-Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Jung-Shun Lee, MD', 'role': 'CONTACT', 'email': 'nslee1218@gmail.com', 'phone': '+886-6-2353535', 'phoneExt': '5291'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}