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Adenoma

Pituitary Diseases

Pituitary Neoplasms

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Endocrine Gland Neoplasms

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Nervous System Neoplasms

Transsphenoidal resection of pituitary adenoma

Transsphenoidal resection

Richard Drexler, MD

Jörg Flitsch, MD

Franz L Ricklefs, MD

To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following transsphenoidal resection of pituitary adenomas.

Surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. Therefore, monitoring and quality improvement is increasingly important in surgery. For this purpose, different concepts were developed with the aim to assess best achievable results for several surgical procedures and reduce unwarranted variation between different centers. The concept of a benchmark establishes reference values which represents the best possible outcome of high-volume centers and can be used for comparison and improvement. In the past years, the concept of benchmarking attaches greater importance in the field of healthcare, especially in surgery. Benchmark values are established within a patients' cohort for which the best possible outcome can be expected. To date, no valid concept exists to describe the outcome of patients after transsphenoidal resection of pituitary adenomas. The aim of our study is the establishment of robust and standardized outcome references after transsphenoidal surgery. After successful implantation of benchmarks from an international cohort of renowned centers, these data serve as reference values for the evaluation of novel surgical techniques and comparisons among centers or future clinical trials.

Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas

Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas - An Analysis of Standardized Outcome References From an International Multicentre Cohort

None, transsphenoidal surgery, pharmacotherapy, radiotherapy

Intraventricular extension, sinus cavernous invasion

Endoscopy, microscopy, 3D-video microscopy, hybrid

None, muscle/fascial patch, fibrin alone, mucosal flap, fat, other technique

Brigham and Women's Hospital

Universitätsklinikum Hamburg-Eppendorf

Principal Investigator

Symptoms and General Pathology

Cysts

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Dermatologic Agents

Anti-Infective Agents

Dexamethasone

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Epinephrine

Dexamethasone acetate

Racepinephrine

Epinephryl borate

BB 1101

Hydrocortisone-17-butyrate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg

Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).

hydrocortisone

0.5mg every 6 hours for a total of four doses

dexamethasone

Julie M. Silverstein, M.D.

During transsphenoidal resection of pituitary tumors and cysts, surgery is performed by a neurosurgeon and ear nose and throat surgeon. The pituitary tumor or cyst is reached by making a small hole in the back of the nose into the bottom of the skull. The surgeon is able to see the pituitary and tumor with an endoscope and remove the tumor through the hole.

Surgery on the pituitary can cause disruption in the secretion of ACTH and cause adrenal failure (lack of cortisol secretion) which can cause nausea, vomiting, low blood pressure, and rarely can be fatal. There is no consensus among endocrinologists and neurosurgeons about the use of perioperative steroids in pituitary patients. Traditionally, all patients undergoing pituitary surgery were given steroids before, during, and after surgery because of the assumption that there would be some compromise in the amount of ACTH released by the pituitary as a result of surgical trauma. Studies have failed to show, however, that ACTH secretion is in fact compromised during transsphenoidal pituitary microsurgery. As a result, there are some centers that routinely give perioperative steroids to all patients undergoing pituitary surgery and there are some centers that do not routinely give perioperative steroids. There are several retrospective and prospective studies that have addressed this issue and have shown that withholding perioperative steroids is safe, but there has never been a prospective study comparing the two approaches.

Objectives: The goal of this study is to prospectively compare two approaches to the perioperative management of patients undergoing transsphenoidal resection of a pituitary tumor or cyst. One protocol includes the routine use of perioperative steroids and the other does not. The investigators hypothesis, based on previous studies, is that patients who are adrenally sufficient do not routinely need to be treated with perioperative steroids. The investigators also hypothesize that the use of perioperative steroids may be associated with a higher rate of adverse outcomes

Patients who are scheduled to undergo transsphenoidal resection for a pituitary tumor or cyst at the investigators institution will be screened prior to surgery for eligibility for this study. All patients deemed eligible will undergo a cosyntropin stimulation test to evaluate for adrenal insufficiency. Patients with adrenal insufficiency will be excluded from the study.

Peri-Operative Steroid Management in Patients

The Use of Perioperative Steroids in Patients Undergoing Transsphenoidal Resection of Pituitary Tumors or Cysts

Adrenal insufficiency was defined by a 30 or 60 min cortisol \< 18 during a cosyntropin stimulation test

Patient charts were reviewed to identify patients who were discharged on prednisone

Washington University School of Medicine

Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg

hydrocortisone: 100mg at the time of surgery

dexamethasone: 0.5mg every 6 hours for a total of four doses

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas	NCT04951557	Pituitary Adeno... Pituitary Tumor Pituitary Disea...	Transsphenoidal...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Peri-Operative Steroid Management in Patients	NCT02084134	Pituitary Adeno... Pituitary Disea...	hydrocortisone dexamethasone	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for transsphenoidal resection