Pituitary Neoplasms Clinical Trial
Official title:
Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age >= 18 - Surgical patients with MRI-confirmed diagnosis of sellar lesions (non-functioning pituitary adenoma or craniopharyngioma) Exclusion Criteria: - Patients with pre-existing hyperthyroidism or Cushing's syndrome - Patients with long-term glucocorticoids replacement history - Patients with other co-morbidities that pose known influence upon the HPA-axis function (cardiovascular or cerebrovascular disease, metabolic disease or epilepsy) - Patients with severe panhypopituitarism - Patients with history of radiotherapy of the pituitary gland |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | West China Hospital, Sichuan University | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline plasma cortisol level | Plasma cortisol at 8:00, 16:00, 24:00 respectively | 1, 3, 5, 7, 30, 90, 180, 360 days post-op | No |
Primary | Change from baseline plasma ACTH level | ACTH at 8:00; | 1, 3, 5, 7, 30, 90, 180, 360 days post-op | No |
Primary | Change from baseline 24-hour urine free cortisol | 24-hour urine free cortisol | 1, 3, 5, 7, 30, 90, 180, 360 days post-op | No |
Primary | Change from baseline insulin tolerance test result | insulin tolerance test result | 7, 30, 90 days post-op | No |
Secondary | Change from baseline plasma TSH level | plasma TSH level | 1, 3, 5, 7, 30, 90, 180, 360 days post-op | No |
Secondary | Sodium, potassium concentration in the blood and urine | Concentration of sodium, potassium in the blood and urine | Daily post-op,for the duration of hospital stay, an expected average of 7 days | No |
Secondary | Number of patients with postoperative infection | Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary. | For the duration of hospital stay, an expected average of 7 days | No |
Secondary | Change from baseline health-related quality of life | The 15-Dimensions measure of health-related quality of life | 7, 30, 90 days post-op | No |
Secondary | Number of patients with recurred tumor | Enhanced MRI scan of the sellar region. | 3,6,12 months after surgery | No |
Secondary | Change from baseline plasma free T3 level | plasma free T3 level | 1, 3, 5, 7, 30, 90, 180, 360 days post-op | No |
Secondary | Change from baseline plasma free T4 level | plasma free T4 level | 1, 3, 5, 7, 30, 90, 180, 360 days post-op | No |
Secondary | Urine output | 24-hour urine output | Daily post-op,for the duration of hospital stay, an expected average of 7 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02549768 -
Effect of Dexmedetomidine on Plasmatic Cortisol Response in Transsphenoidal Surgery
|
Phase 4 | |
Terminated |
NCT02629549 -
Intraoperative Imaging of Pituitary Adenomas by OTL
|
Phase 1 | |
Recruiting |
NCT02288962 -
Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas
|
Phase 3 | |
Terminated |
NCT02743442 -
Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland
|
N/A | |
Completed |
NCT02632084 -
Follow-up Evaluation of Photo-Dynamic Therapy for Pituitary Tumours
|
N/A | |
Not yet recruiting |
NCT06282224 -
Application of Augmented Reality Neuronavigation in Transnasal Endoscopic Skull Base Surgery
|
N/A | |
Recruiting |
NCT05108064 -
Radiomic and Pathomic Study of Pituitary Adenoma Using Machine Learning
|
||
Active, not recruiting |
NCT03665064 -
Long Term Outcome Study in Patients With Pituitary Disorders
|
||
Recruiting |
NCT01775332 -
Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools
|
N/A | |
Completed |
NCT05088252 -
Desflurane and Anesthesia Recovery Period in Endonasal Endoscopic Pituitary Adenoma Resection
|
N/A |