Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-04 @ 10:43 PM
Study NCT ID:
NCT02190994
Status:
UNKNOWN
Last Update Posted:
2014-07-15
First Post:
2014-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}, {'id': 'D003397', 'term': 'Craniopharyngioma'}], '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'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-11', 'studyFirstSubmitDate': '2014-07-05', 'studyFirstSubmitQcDate': '2014-07-11', 'lastUpdatePostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline plasma cortisol level', 'timeFrame': '1, 3, 5, 7, 30, 90, 180, 360 days post-op', 'description': 'Plasma cortisol at 8:00, 16:00, 24:00 respectively'}, {'measure': 'Change from baseline plasma ACTH level', 'timeFrame': '1, 3, 5, 7, 30, 90, 180, 360 days post-op', 'description': 'ACTH at 8:00;'}, {'measure': 'Change from baseline 24-hour urine free cortisol', 'timeFrame': '1, 3, 5, 7, 30, 90, 180, 360 days post-op', 'description': '24-hour urine free cortisol'}, {'measure': 'Change from baseline insulin tolerance test result', 'timeFrame': '7, 30, 90 days post-op', 'description': 'insulin tolerance test result'}], 'secondaryOutcomes': [{'measure': 'Change from baseline plasma TSH level', 'timeFrame': '1, 3, 5, 7, 30, 90, 180, 360 days post-op', 'description': 'plasma TSH level'}, {'measure': 'Sodium, potassium concentration in the blood and urine', 'timeFrame': 'Daily post-op,for the duration of hospital stay, an expected average of 7 days', 'description': 'Concentration of sodium, potassium in the blood and urine'}, {'measure': 'Number of patients with postoperative infection', 'timeFrame': 'For the duration of hospital stay, an expected average of 7 days', 'description': 'Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary.'}, {'measure': 'Change from baseline health-related quality of life', 'timeFrame': '7, 30, 90 days post-op', 'description': 'The 15-Dimensions measure of health-related quality of life'}, {'measure': 'Number of patients with recurred tumor', 'timeFrame': '3,6,12 months after surgery', 'description': 'Enhanced MRI scan of the sellar region.'}, {'measure': 'Change from baseline plasma free T3 level', 'timeFrame': '1, 3, 5, 7, 30, 90, 180, 360 days post-op', 'description': 'plasma free T3 level'}, {'measure': 'Change from baseline plasma free T4 level', 'timeFrame': '1, 3, 5, 7, 30, 90, 180, 360 days post-op', 'description': 'plasma free T4 level'}, {'measure': 'Urine output', 'timeFrame': 'Daily post-op,for the duration of hospital stay, an expected average of 7 days', 'description': '24-hour urine output'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hydrocortisone', 'Pituitary adenomas', 'Replacement therapy'], 'conditions': ['Pituitary Neoplasms', 'Craniopharyngiomas']}, 'descriptionModule': {'briefSummary': 'The purpose of this four-arm randomized controlled study is to determine whether eliminating glucocorticoids (GC) replacement in perioperative period in surgical patients with sellar lesion could result in similar or better outcomes comparing to traditional replacement therapy, regarding postoperative recovery of pituitary function and other postoperative complications (infection, pain, quality of life, recurrence). Surgical patients of our center with MRI-confirmed diagnosis of sellar lesion will be enrolled, insulin tolerance test (ITT) will be performed for assessment of the pituitary function at enrollment. Patients with normal pituitary function will be randomized into non-GC replacement group (group A) and low-dose GC replacement group (group B), while patients with impaired pituitary function will be randomized into low-dose GC replacement group (group C) and high-dose GC replacement group (group D). The primary outcome is the hypothalamic-pituitary-adrenal (HPA) -axis function of the patients, evaluated by plasma cortisol and adrenocorticotropic hormone (ACTH) levels. The secondary outcomes include the hypothalamic-pituitary-thyroid (HPT) axis function (TSH, thyroid-stimulating hormone, free T3, free T4), postoperative water-electrolyte balance, infection, recurrence and health-related quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>= 18\n* Surgical patients with MRI-confirmed diagnosis of sellar lesions (non-functioning pituitary adenoma or craniopharyngioma)\n\nExclusion Criteria:\n\n* Patients with pre-existing hyperthyroidism or Cushing's syndrome\n* Patients with long-term glucocorticoids replacement history\n* Patients with other co-morbidities that pose known influence upon the HPA-axis function (cardiovascular or cerebrovascular disease, metabolic disease or epilepsy)\n* Patients with severe panhypopituitarism\n* Patients with history of radiotherapy of the pituitary gland"}, 'identificationModule': {'nctId': 'NCT02190994', 'briefTitle': 'Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions', 'orgStudyIdInfo': {'id': 'WestChina-2013137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'A. Normal function, non-GC replacement', 'description': 'No glucocorticoid replacement will be given perioperatively.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B. Normal function, low-dose GC', 'description': 'Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;', 'interventionNames': ['Drug: Hydrocortisone', 'Drug: Prednisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C. Impaired function, low-dose GC', 'description': 'Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;', 'interventionNames': ['Drug: Hydrocortisone', 'Drug: Prednisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D. Impaired function, high-dose GC', 'description': 'Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1 and day 2. 60mg hydrocortisone at day 3; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet per day, since postoperative day 3.', 'interventionNames': ['Drug: Hydrocortisone', 'Drug: Prednisone']}], 'interventions': [{'name': 'Hydrocortisone', 'type': 'DRUG', 'description': 'used intravenously', 'armGroupLabels': ['B. Normal function, low-dose GC', 'C. Impaired function, low-dose GC', 'D. Impaired function, high-dose GC']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'used as tablet form', 'armGroupLabels': ['B. Normal function, low-dose GC', 'C. Impaired function, low-dose GC', 'D. Impaired function, high-dose GC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Senlin Yin, M.D.', 'role': 'CONTACT', 'email': 'enforest@gmail.com', 'phone': '+86 13072808795'}, {'name': 'Shu Jiang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Senlin Yin, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Peizhi Zhou, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Senlin Yin, M.D.', 'role': 'CONTACT', 'email': 'enforest@gmail.com', 'phone': '+86 13072808795'}], 'overallOfficials': [{'name': 'Shu Jiang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital, Sichuan University, Chengdu, Sichuan, PR China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Shu Jiang', 'investigatorFullName': 'Shu Jiang', 'investigatorAffiliation': 'West China Hospital'}}}}