Nervous System Diseases

Gland and Hormone Related Diseases

All Conditions

Neoplasms

Pituitary Diseases

Hypothalamic Neoplasms

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Lidocaine

Anesthetics

Anesthetics, Local

Patients having pituitary gland surgery

Inclusion criteria - Any adult patient undergoing trans-sphenoidal pituitary surgery.

Exclusion criteria - Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery

Trans-sphenoidal resection of a pituitary gland lesion.

Pituitary surgery

The surgeon infiltrates the nasal septum with local anaesthesia as per usual practice. This consists of Moffet's solution and lidocaine with adrenaline (1:200,000).

local anaesthetic injection

Matthew D Wiles, FRCA FFICM

The purpose of this study is to determine the effects on the heart of injecting local anaesthetic into the nose prior to surgery on the pituitary gland?

People sometimes require surgery on their pituitary gland. This is a gland at the base of your brain which secretes hormones. At the Royal Hallamshire Hospital the investigators are currently conducting a study into the effects of local anaesthetic (a medicine which causes numbness) injection on patients undergoing this particular type of operation.

After patients are anaesthetised (asleep) but before surgery starts the surgeon injecst a local anaesthetic solution into the nose. This is routine practice and is done to provide pain relief afterwards and also to decrease the amount of bleeding during the operation to ensure that the surgeon has a good view.

The investigators have known for a long time that local anaesthetic affects the heart rate and blood pressure, however the investigators would like to describe exactly how, in much more detail.

The Cardiovascular Changes Associated With Septal Local Anaesthesia

An Observational Study of the Cardiovascular Response to Infiltration of Local Anaesthetic Into the Nasal Septum in Patients Undergoing Trans-sphenoidal Resection of a Pituitary Lesion

Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.

Changes in cardiac output from baseline after infiltration of local anaesthetic.

Changes in systemic vascular resistance from baseline after infiltration of local anaesthetic.

Sheffield Teaching Hospitals NHS Foundation Trust

Nutritional and Metabolic Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Musculoskeletal Diseases

Rare Diseases

Diabetes Mellitus

Diabetes Insipidus, Neurogenic

Acromegaly

Diabetes Insipidus

Pituitary Neoplasms

Hyperprolactinemia

Prolactinoma

ACTH-Secreting Pituitary Adenoma

Pituitary ACTH Hypersecretion

Adenoma

Bone Diseases

Bone Diseases, Endocrine

Endocrine Gland Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Central Diabetes Insipidus

Galactorrhoea-Hyperprolactinaemia

ACTH-secreting Pituitary Adenoma

Natriuretic Agents

Vasoconstrictor Agents

Coagulants

Hormones

Arginine Vasopressin

Hormone Antagonists

Patients diagnosed with Cushing's disease

Patients diagnosed with hyperprolactinemia/prolactinoma

Patients diagnosed with pituitary stalk lesions

Patients diagnosed with nonfunctioning pituitary adenomas

Patients diagnosed with central diabetes insipidus

Patients diagnosed with craniopharyngiomas

Patients diagnosed with other suprasellar/parasellar lesions

1. Medical history
2. Imaging examination including brain magnetic resonance imaging
3. Blood (Basal hormone study and follow-up study) and pituitary tumor tissue

Dynamic hormone study and Magnetic resonance imaging

Jung Hee Kim, M.D

The purpose of this study is to investigate the treatment and natural history of pituitary disease. We have a longstanding interest in pituitary disease including acromegaly, central diabetes insipidus, and nonfunctioning pituitary adenoma. We will continue to follow patients and recruit new patients for treatment and follow-up. Blood and pituitary tumor tissue (when available through clinical care) will be saved for future analyses related to pituitary disease.

Subjects for this study will be recruited if they are:

1. Adults, male or female aged 18 years or older
2. Have been diagnosed with pituitary diseases

Seoul National University Pituitary Disease Cohort Study

Visual field defect or hypopituitarism, hormone hyperfunction-related complications

Seoul National University Hospital

Principal Investigator

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

To determine the outcomes of patients with different pituitary disorders whether they are managed medically, surgically or expectantly.

A chart audit of around 1500 patients seen in two specific clinics, the Medical Pituitary Clinic and the combined Endocrine/Neurosurgical Pituitary Clinic at the University of Alberta Hospital, will be performed to determine the effectiveness of various treatment strategies on the long term outcome of specific pituitary disorders. The investigator's will collect retrospective demographic (age, sex, ethnicity), clinical (mode of presentation, hormonal parameters) and therapeutic outcome (surgical, medical, expectant and / or radiation treatment; co-morbidities and complications) of patients seen in these two clinics between January 2000 and December 2020.

Long Term Outcome Study in Patients With Pituitary Disorders

Using clinical, biochemical and imaging studies of a cohort of surgically operated patients to identify prognostic factors of tumor recurrence

University of Alberta

Symptoms and General Pathology

Cysts

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal 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

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
The Cardiovascular Changes Associated With Septal Local Anaesthesia	NCT03137615	Hypothalamic Ne... Pituitary Disea... Anesthesia, Loc...	Pituitary surge... local anaesthet...	17 Years -	Sheffield Teaching Hospitals NHS Foundation Trust
Seoul National University Pituitary Disease Cohort Study	NCT03474601	Pituitary Disea... Pituitary Incid... Acromegaly Central Diabete... Pituitary Stalk... Cushing's Disea... Pituitary Tumor Prolactinoma	Dynamic hormone...	18 Years -	Seoul National University Hospital
Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas	NCT04951557	Pituitary Adeno... Pituitary Tumor Pituitary Disea...	Transsphenoidal...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Long Term Outcome Study in Patients With Pituitary Disorders	NCT03665064	Pituitary Disea... Pituitary Neopl...		-	University of Alberta
Seoul National University Pituitary Disease Cohort Study	NCT03474601	Pituitary Disea... Pituitary Incid... Acromegaly Central Diabete... Pituitary Stalk... Cushing's Disea... Pituitary Tumor Prolactinoma	Dynamic hormone...	18 Years -	Seoul National University Hospital
Peri-Operative Steroid Management in Patients	NCT02084134	Pituitary Adeno... Pituitary Disea...	hydrocortisone dexamethasone	18 Years -	Washington University School of Medicine
Seoul National University Pituitary Disease Cohort Study	NCT03474601	Pituitary Disea... Pituitary Incid... Acromegaly Central Diabete... Pituitary Stalk... Cushing's Disea... Pituitary Tumor Prolactinoma	Dynamic hormone...	18 Years -	Seoul National University Hospital
Long Term Outcome Study in Patients With Pituitary Disorders	NCT03665064	Pituitary Disea... Pituitary Neopl...		-	University of Alberta

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