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The investigators hypothesize that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose hypothalamus pituitary adrenal axis are intact are safe.
Pituitary is the headquarters of the endocrine system of the body, secreting several hormones maintaining the normal function of the endocrine organs. After surgery, pituitary dysfunction is seen in a small proportion of patients, even in some patients resulting in severe consequence, i.e. adrenal insufficiency or pituitary crisis. Therefore, patients undergoing pituitary surgery have been usually given "stress dose" steroids whether their hypothalamus pituitary adrenal (HPA) axis are deficient or preserved.
Results of several retrospective studies showed that there was no significantly increase in postoperative adrenal insufficiency in no supplementation (of hydrocortisone) group than in supplementation group. Given the considerable side effects of using steroids, whether hydrocortisone administration is necessary for all patients with pituitary adenomas during peri-operation needs to be discussed.
For Chinese patients with pituitary adenomas except for those of Cushing's disease, hydrocortisone administration during the peri-operation is a routine practice. Peking Union Medical College Hospital is the China Pituitary Disease Registry Center. Here, the investigators aim to launch a single-center prospective randomized controlled trial to verify the hypothesis that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose HPA axis are intact are safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrocortisone withholding group | Experimental | Patients receive no hydrocortisone |
|
| Hydrocortisone group | Active Comparator | Patients receive routine hydrocortisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Drug | No hydrocortisone or other steroids are given before, during, and after the surgery, except that patients develop postoperative adrenal insufficiency. If a patient develops postoperative adrenal insufficiency, he/she needs to receive hydrocortisone treatment (20mg at 0800 and 20mg at 1600) for one month and then check the level of morning serum cortisol to decide if it is time to start the hydrocortisone taper program. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of newly-onset adrenal insufficiency | Adrenal insufficiency: lower-than-normal serum cortisol level at 8 a.m., plus the following related symptoms, including serious fatigue, muscle weakness, decreased appetite, nausea, vomiting, diarrhea, low blood pressure, palpitation, and fever. | During the first 3 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of newly-onset adrenal insufficiency | Adrenal insufficiency: lower-than-normal serum cortisol level at 8 a.m., plus the following related symptoms, including serious fatigue, muscle weakness, decreased appetite, nausea, vomiting, diarrhea, low blood pressure, palpitation, and fever. | From the 3rd postoperative day to the 3rd postoperative month |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of newly-developed diabetes mellitus | A random reading of blood sugar level more than 200 mg/dL (11.1 mmol/L), or a reading after two hours (after OGTT) over 200 mg/dL (11.1 mmol/L) indicates diabetes mellitus. | During the first 3 postoperative months |
| Rate of newly-developed diabetes insipidus |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Xing, MD | Contact | +861069152530 | xingbingemail@aliyun.com | |
| Xiaopeng Guo, MD | Contact | +8617701220936 | guoxiaopeng_pumch@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Xing, MD | Neurosurgery, Peking Union Medical College Hospital, Beijing, China | Study Chair |
| Wei Lian, MD | Neurosurgery, Peking Union Medical College Hospital, Beijing, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25775019 | Background | Tohti M, Li J, Zhou Y, Hu Y, Yu Z, Ma C. Is peri-operative steroid replacement therapy necessary for the pituitary adenomas treated with surgery? A systematic review and meta analysis. PLoS One. 2015 Mar 16;10(3):e0119621. doi: 10.1371/journal.pone.0119621. eCollection 2015. | |
| 30325449 | Background | Sterl K, Thompson B, Goss CW, Dacey RG, Rich KM, Zipfel GJ, Chicoine MR, Kim AH, Silverstein JM. Withholding Perioperative Steroids in Patients Undergoing Transsphenoidal Resection for Pituitary Disease: Randomized Prospective Clinical Trial to Assess Safety. Neurosurgery. 2019 Aug 1;85(2):E226-E232. doi: 10.1093/neuros/nyy479. |
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The individual participant data will be available upon reasonable requests to the study chair, Dr. Bing Xing, or the study director, Dr. Wei Lian.
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Participants are assigned to one of two groups, whether using hydrocortisone or not during peri-operation, in parallel for the duration of the study.
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Participant, investigator, and outcome assessors are all prevented from having knowledge of the interventions assigned to individual participants. Care provider knows the individualized interventions.
|
|
| Hydrocortisone | Drug | Hydrocortisone sodium succinate is given on the operation day (100mg at 0800 & 100mg at 2000), the postoperative day 1 (100mg at 0800 & 50mg at 2000), and the postoperative day 2 (25mg at 0800). Hydrocortisone (po.) is then given starting from the afternoon of postoperative day 2 (20mg at 1600 and 0800) to the end of the first postoperative week, and 20mg at 0800 during the second postoperative week. This is called the "hydrocortisone taper program". If a patient develops postoperative adrenal insufficiency, he/she needs to receive hydrocortisone treatment (20mg at 0800 and 20mg at 1600) for one month and then check the level of morning serum cortisol to decide if it is time to start the hydrocortisone taper program. |
|
|
Urine volume > 300ml for more than 3h or > 6 liter per day, specific gravity of urine <1.003, and serum sodium levels > 145 mmol/L indicate diabetes insipidus. |
| During the first 3 postoperative months |
| Concentration of blood electrolytes | The level of Na+, K+, and Ca++ in the blood | At the 3rd postoperative month |
| Concentration of blood cells | Numbers of erythrocytes, leukocytes, neutrophils, lymphocytes, thrombocytes in the blood | At the 3rd postoperative month |
| Percentage of blood cells | Percentage of neutrophils, monocytes, lymphocytes of the leukocytes | At the 3rd postoperative month |
| Concentration of indexes of coagulation function #1 | Prothrombin time, activated partial thromboplastin time, and thrombin time | At the 3rd postoperative month |
| Level of international normalized ratio | Level of international normalized ratio | At the 3rd postoperative month |
| Level of D-Dimer | Level of D-Dimer | At the 3rd postoperative month |
| Rate of deep venous thrombosis | Deep venous thrombosis as detected by ultrasound | During the first 3 postoperative months |
| Rate of other complications | Decreased bone density, osteoporosis, fracture, acne, and infections. | During the first 3 postoperative months |
| 31978882 | Background | Lee HC, Yoon HK, Kim JH, Kim YH, Park HP. Comparison of intraoperative cortisol levels after preoperative hydrocortisone administration versus placebo in patients without adrenal insufficiency undergoing endoscopic transsphenoidal removal of nonfunctioning pituitary adenomas: a double-blind randomized trial. J Neurosurg. 2020 Jan 24;134(2):526-534. doi: 10.3171/2019.11.JNS192381. Print 2021 Feb 1. |
| 36383383 | Derived | Guo X, Zhang D, Pang H, Wang Z, Gao L, Wang Y, Ma W, Lian W, Xing B; ZS-2608 Trial Team. Safety of Withholding Perioperative Hydrocortisone for Patients With Pituitary Adenomas With an Intact Hypothalamus-Pituitary-Adrenal Axis: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242221. doi: 10.1001/jamanetworkopen.2022.42221. |
| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D000307 | Adrenal Gland Diseases |
| D011282 |
| Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |