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Pituitary Diseases clinical trials

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NCT ID: NCT04425954 Completed - Pituitary Adenoma Clinical Trials

Evaluation of Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery

Start date: January 1, 2019
Phase:
Study type: Observational

This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

NCT ID: NCT04369703 Completed - Pituitary Tumor Clinical Trials

Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery

Start date: January 28, 2020
Phase:
Study type: Observational

1. Access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy. 2. Access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy 3. Access the relative change in copeptin values between baseline and post-surgery as a predictor for diabetes insipidus development.

NCT ID: NCT04326569 Completed - Pituitary Surgery Clinical Trials

Copeptin in the Diagnosis of Post-operative Insipidus Diabetes After Pituitary Surgery

Copeptin-surg
Start date: January 3, 2022
Phase: N/A
Study type: Interventional

Endoscopic trans-sphenoidal pituitary endoscopic surgery is one of the main axes of management of tumours of the sellar region. Central diabetes insipidus is a frequent complication of endoscopic trans-sphenoidal pituitary endoscopic surgery, with a prevalence of up to 30% of cases. It is the consequence of insufficient secretion of the anti-diuretic hormone arginine vasopressin (AVP) by the posterior pituitary (Melmed et al, 2017). In the absence of specific treatment, diabetes insipidus can lead to severe ionic and osmotic disorders, mainly acute dehydration with the risk of severe consequences particularly neurological. Monitoring for the appearance of diabetes insipidus is therefore necessary from the immediate post-operative period. To date, diabetes insipidus is initially suspected before the appearance of major polyuria. Several biological assays (urinary density, natraemia, urinary osmolarity and plasma) can help to confirm the diagnosis, but the sensitivity and specificity of these biomarkers remains quite low for this indication. The determination of MVA is difficult because this hormone is unstable ex vivo. To date, its use in current practice remains complicated. MVA and copeptin are derived from the same precursor and are therefore co-secreted by the pituitary gland in equimolar proportions. Copeptin has a relatively short in vivo half-life of about 25 minutes, as does MVA, but is more stable in vitro when blood has been drawn. Its use in the early diagnosis of diabetes insipidus after pituitary surgery could therefore be of interest.

NCT ID: NCT04284605 Completed - Pituitary Adenoma Clinical Trials

Effects Exercise Training in Patients With Pituitary Adenoma

Start date: May 15, 2020
Phase: N/A
Study type: Interventional

This study planned to investigate the effects of aerobic training combined with strengthening training and yoga on biochemical factors, physical performance and quality of life in people with pituitary adenoma. The hypotheses are; H1: Aerobic training combined with strengthening training is effective on biochemical factors in people with pituitary adenoma. H2: Aerobic training combined with strengthening training is effective on physical performance in people with pituitary adenoma. H3: Aerobic training combined with strengthening training is effective on quality of life in people with pituitary adenoma. H4: Yoga is effective on biochemical factors in people with pituitary adenoma. H5: Yoga is effective on physical performance in people with pituitary adenoma. H6: Yoga is effective on quality of life in people with pituitary adenoma. H7: Aerobic training combined with strengthening training and yoga is effective on biochemical factors, physical performance and quality of life in people with pituitary adenoma.

NCT ID: NCT04268251 Completed - Clinical trials for Cavernous Sinus Invasion by Pituitary Adenoma

Evaluation of Cavernous Sinus Invasion by Pituitary Adenoma Using Deep Learning Based Denoising MR

Start date: January 12, 2020
Phase: N/A
Study type: Interventional

Preoperative evaluation of cavernous sinus invasion by pituitary adenoma is critical for performing safe operation and deciding on surgical extent as well as for treatment success. Because of the small size of the pituitary gland and sellar fossa, determining the exact relationship between the pituitary adenoma and cavernous sinus can be challenging. Performing thin slice thickness MRI may be beneficial but is inevitably associated with increased noise level. By applying deep learning based denoising algorithm, diagnosis of cavernous sinus invasion by pituitary adenoma may be improved.

NCT ID: NCT04212793 Completed - Pituitary Adenoma Clinical Trials

Detection of PitNET Tissue During TSS Using Bevacizumab-800CW

DEPARTURE
Start date: October 28, 2020
Phase: Phase 1
Study type: Interventional

There is a need for improved visualization of presence and extent of pituitary neuroendocrine tumor (PitNET) tissue during transsphenoidal surgery (TSS), especially in tumors invading the cavernous sinus (CS). Optical molecular imaging of PitNET associated biomarkers is a promising technique to accommodate this need. Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in PitNET tissue compared to normal pituitary tissue and has proven to be a valid target for molecular imaging. Bevacizumab is an antibody that binds VEGF-A. By conjugating a fluorescent dye to this antibody, the fluorescent tracer molecule bevacizumab-800CW is created, which binds to VEGF-A. The investigators hypothesize that bevacizumab-800CW accumulates in PitNET tissue, enabling visualization using a molecular fluorescence endoscopy system. In this pilot intervention study the investigators will determine the feasibility of using microdoses (4.5, 10 and 25 mg) of bevacizumab-800CW to detect PitNET tissue intraoperatively.

NCT ID: NCT04119206 Completed - Hyponatremia Clinical Trials

Tolvaptan Versus Fluid Restriction in SIADH

Start date: January 1, 2009
Phase:
Study type: Observational

Context. The relevance of hyponatremia has been acknowledged by guidelines from the United States of America (2013) and Europe (2014). However, treatment recommendations differ due to limited evidence. Objective. In hyponatremia following pituitary surgery - caused by the syndrome of inappropriate antidiuretic hormone (SIADH) secretion - the investigators compared fluid restriction with the pharmacological increase of water excretion by blocking the vasopressin 2 receptors with tolvaptan at a low and moderate dose. Design. Prospective observational study. Setting. Neurosurgical Department of a University hospital with more 200 pituitary procedures per year. Patients. Participants undergoing surgery for sellar lesions and developing a serum sodium below 135 mmol/L. The diagnosis of SIADH was established by eu- or hypervolemia (daily measurement of body weight and fluid balance daily), an inappropriately concentrated urine (specific gravity) and exclusion of a cortico- and thyreotropic insufficiency. Intervention. Participants were treated with fluid restriction (n=38) or tolvaptan at 3.75 (n=38) or 7.5 mg (n=48) orally. Main Outcome Measures. Treatment efficacy was assessed by the duration of hyponatremia, sodium nadir and length of hospitalization. Safety was established by an increment serum sodium below 10 mmol/L per day and exclusion of side effects.

NCT ID: NCT04076046 Completed - Pituitary Adenoma Clinical Trials

Multicentric Prospective Validation of the Zurich Pituitary Score

Start date: November 1, 2019
Phase:
Study type: Observational [Patient Registry]

Predictive analytics for GTR, EOR and RV are useful in surgical decision-making, particularly whenever there is no unequivocal indication for surgery. Several factors have been shown to have a role in predicting GTR. Among these, the Knosp classification has proven over the years to be a good predictor of GTR. The score is based on the lateral extension of the adenoma in relation the the intracranial bedding of the internal carotid artery. However, recent literature has demonstrated that the Knosp classification suffers from relatively poor interrater agreement. Moreover the classification was conceived in an era when endoscopic techniques were not available: nowadays endoscopic technique allows visualization and possibly also reaching portions of adenoma which at the time when the Knosp classification was introduced were simply not possible. Lastly, the efficacy of the Knosp's score in predicting also EOR and RV has never been tested. Recently a new score - the Zurich Pituitary Score (ZPS) has been proposed at the University Hospital of Zürich (USZ). The score has proved in the examined series to be more powerful than the Knosp classification in predicting GTR, EOR and RV. A good interrater agreement was also demonstrated. The score however, has been validated only in a monocentric setting with a limited number of patients. The aim of this study is to assess the (1) predictive ability of the ZPS for GTR, EOR, and RV, and (2) the inter-rater agreement of the ZPS in an external validation study.

NCT ID: NCT03807076 Completed - Clinical trials for Acromegaly Due to Pituitary Adenoma

Modulating the GIP System in Patients With Acromegaly Due to a Pituitary Tumor

GA-9
Start date: August 13, 2019
Phase: N/A
Study type: Interventional

Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma

NCT ID: NCT03624114 Completed - Pituitary Adenoma Clinical Trials

Prediction of Sphenoid Septation in MRI Compared With CT and Intraoperative Findings During Endoscopic Pituitary Adenoma Surgery

Scope
Start date: January 1, 2018
Phase:
Study type: Observational

To investigate whether MRI is able to predict the exact anatomy and topography of the sphenoid sinus and its relationship to the sellar, parasellar und paraclinoid region and where CT yields more detailed information for the surgeon before trans-sphenoidal pituitary adenoma surgery.