Neoplasms

All Conditions

Nervous System Diseases

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Rare Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Craniopharyngioma

Adamantinoma

Ameloblastoma

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Bone Neoplasms

Bone Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Neuroepithelioma

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Anesthetics

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Prednisone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

No glucocorticoid replacement will be given perioperatively.

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;

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.

Senlin Yin, M.D.

Shu Jiang, M.D.

Peizhi Zhou, M.D.

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.

Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions

Plasma cortisol at 8:00, 16:00, 24:00 respectively

Concentration of sodium, potassium in the blood and urine

Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary.

The 15-Dimensions measure of health-related quality of life

West China Hospital

Professor Shu Jiang

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Obesity

Neoplasm Metastasis

Hyperinsulinism

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Antihypertensive Agents

Vasodilator Agents

Diazoxide

DIAZOXIDE

Raja BRAUNER, MD,PhD

In children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas

Approximately 80 % of the hypothalamic-pituitary lesions that occur in children are craniopharyngiomas with one or three cases per 1 million children each year.

One major problem remains unsolved : the obesity

This study is performed to optimize the management of the children with hypothalamic-pituitary lesions by reducing the hyperinsulinemia due to the lesion and the surgery

Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions

Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions

Assistance Publique - Hôpitaux de Paris

Isabelle BRINDEL

The 198 cases of CP with primary surgery in our hospital (since July, 1997 until now) were divided into three topographical groups based on the pre-operative MRI, intraoperative findings and the tumor-membrane relationship. The presurgical manifestation, the different surgical approach, intraoperative techniques, and postoperative complication were described and analyzed to establish a normalized surgical treatment of individual CP patient, which has the highest rate of the totally tumoral resection and the lowest rate of the hypothalamic injury.

The anticipated 40 cases of CP were surgical treated by our standard procedure, which is recruited in the prospective cohort. With the long-term follow up, QOL including the cognition, circadian rhythm, endocrine, Water-Electrolyte, and body weight et al were evaluated to assess the rationality of the treatment. Then according to the results, the surgical treatment was modified, and the endocrinic substitution therapy was also been developed.

According to the presurgical MRI, with the analysis of the morphological characteristic of three subtype of CP, different surgical approach and intrasurgical skills were used to treat tumors with trying to total remove tumor and avoid the hypothalamus injury.

Different surgical approach and techniques being used to treat three subtype of CP

Songtao Qi, MD, PhD

With the preliminary anatomical and histological study, the membranous structures of the sellar region was considered to be closely related with the growth pattern of Craniopharyngiomas(CP). By combined considering of the tumor-membrane relationship, this project was trying to classify the CP through retrospectively summarizing the pre- and postoperative imaging (MRI and CT), the intrasurgical findings, and the endocrine data of 198 CPs with primary surgery in our hospital (since 1997 until now). As a result, a distinct and systematic CP classification was proposed. The possible originate site, surgical skills and postoperative treatment of all the subtype tumors were discussed and analyzed to provide a normalized surgical treatment for this kind of tumor. Then in the prospective cohort, the anticipated 100 CP patients will accept the normalized surgical treatment. And by the long term follow up, the postsurgical quantity of life (QOL) of patients was evaluated with aspect in cognition, circadian rhythm, endocrine, Water-Electrolyte and body weight, et al. By comparing with the long-term results of the retrospective cohort, the totally follow up data was statistically analyzed to assess the rationality of this standard treatment of CP.

Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma

Southern Medical University, China

Qi Songtao

Hypothalamic Obesity

Gastrointestinal Agents

Hypoglycemic Agents

Anti-Obesity Agents

Glucagon

Glucagon-Like Peptide 1

Exenatide

Glucagon-Like Peptide-1 Receptor Agonists

Incretins

Treatment with exenatide at the initial dose of 5 µg x 2/day (subcutaneously administered) during 4 weeks, and treatment with 10 µg x 2/day during 5 months.

Patients will be maintained on placebo (injected subcutaneously, twice a day) with the same dose and frequency than exenatide arm.

Placebo

Paul Perez, Dr

Blandine Gatta-Cherifi, Pr

This hypothalamic obesity is associated with serious metabolic and psychosocial consequences.

The purpose of the study is to compare the change of body weight after 6 months treatment with a lifestyle intervention + exenatide compare to the one after the same lifestyle intervention+ placebo in adults patients suffering from a hypothalamic obesity due to treatment of craniopharyngioma.

The development of glucagon-like peptide-1 (GLP-1) analogues might be a solution since native GLP-1 suppresses appetite and energy intake in both normal weight and obese individuals as well as in people with type 2 diabetes and delays gastric emptying. The underlying mechanisms that mediate the effects of weight involve not only central regions like the hypothalamus and the solitary tractus nucleus and area postrema but also peripheral regions as the gastrointestinal tract. These extra hypothalamic effects are of particular interest in the cases of obesity due to hypothalamic lesions.

Exenatide is a glucagon-like peptide-1 (GLP-1) analogue with a high structural homology to human GLP-1, a gut derived incretin hormone. Since exenatide causes a dose-dependent weight loss, decreasing concentration of glycosylated haemoglobin as well as improving ß-cell function and systolic blood pressure, it could be an attractive treatment for both type 2 diabetes and obesity. In a double-blind placebo-controlled 24-week trial, it has been recently shown that non diabetic obese patients maintained on exenatide 10µg x 2/j lost significantly more weight than did those on placebo (5.1 kg versus 1.6).

Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

The primary outcome will be assessed by a weighing machine that measure until 200 kg.

Tolerance will be assessed by the presence of:

- Nauseas, vomiting.

Tolerance will be assessed by the presence of:

- Injection-site symptoms.

Tolerance will be assessed by the presence of :

- Increasing of pulse rate.

Tolerance will be assessed by the presence of :

- Anxiety by Beck scale.

Tolerance will be assessed by the presence of :

- depression evaluated by HAD scale.

Tolerance will be assessed by the presence of :

- Increasing of pancreatic enzymes.

Tolerance will be assessed by the presence of :

- Hypoglycaemia

Levels of blood glucose and insulin, oral glucose tolerance testing, haemoglobin A1C

Levels of HDL cholesterol, triglycerides, LDL cholesterol.

The metabolic parameters considered:

- Body composition (Dual energy-ray absorptiometry) and abdominal obesity (waist circumference).

The eating behaviour will be evaluated by:

- Plasma level of ghrelin measured after an overnight fast.

The eating behaviour will be evaluated by:

- Scores of restriction, hunger and disinhibition (French version of the Three factor Eating Questionnaire).

The eating behaviour will be evaluated by:

- Scores of desire to eat, hunger and fullness at visual analogic scales.

The quality of life will be assessed by:

- Scores of depression (short questionnaire of Beck).

The quality of life will be assessed by:

- Scores of quality of life (ORWELL questionnaire).

The energy expenditure will be estimated thanks to pedometer.

- Resting metabolic rate (indirect calorimetry).

The energy expenditure will be estimated thanks to:

- Resting metabolic rate

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions	NCT02190994	Pituitary Neopl... Craniopharyngio...	Hydrocortisone Prednisone	18 Years -	West China Hospital
Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions	NCT02190994	Pituitary Neopl... Craniopharyngio...	Hydrocortisone Prednisone	18 Years -	West China Hospital
Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions	NCT00306683	Hypothalamic-pi... Craniopharyngio...	DIAZOXIDE	6 Years - 18 Years	Assistance Publique - Hôpitaux de Paris
Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma	NCT00949156	Craniopharyngio...	Different surgi...	1 Year - 70 Years	Southern Medical University, China
Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy	NCT02860923	Craniopharyngio... Hypothalamic Ob...	Exenatide Placebo	18 Years - 75 Years	University Hospital, Bordeaux

Spots Global Cancer Trial Database for craniopharyngiomas