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Previous studies addressing preoperative somatostatin analogs (SSA) treatment and subsequent surgical cure rates are conflicting, reporting a benefit, or no difference between groups. And most reported studies were rather small and were made in retrospect, we conducted a prospective, randomized study to investigate whether 4-month preoperative lanreotide treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with macroadenomas. The investigators also aimed to investigate whether there were differences in the incidence of surgical complications, and duration of neurosurgical hospital stay.
Acromegaly is a rare disease, caused by a growth hormone (GH)-secreting adenoma and in even more seldom instances (about 1%) due to excessive growth hormone-releasing hormone (GHRH) secretion, usually by a carcinoid tumor of the lung or gastrointestinal tract. The incidence of acromegaly is about 3-4 per 1 million per year and the prevalence is 60-70 per 1 million, without geographical or sex differences. Clinical features of acromegaly include acral enlargement, prognathism, jaw malocclusion, arthropathy, carpal tunnel syndrome, hyperhydrosis, sleep apnea, and visceromegaly.
Transsphenoidal neurosurgery, allowing selective removal of the pituitary adenoma, is the current first treatment for acromegaly in the majority of patients. Its effects on GH and insulin-like growth factor I (IGF-I) secretion are rapid and operations have a low morbidity and very low mortality. However, surgery for macroadenomas causing acromegaly has a much lower surgical success rate than that for microadenomas. In experienced hands, microadenomas can be expected to be cured in around 90%, whereas with macroadenomas the figure is around 50%. This is particularly the case with tumours that extend into the cavernous sinus where surgical success is < 50%. Medical treatment of acromegaly with somatostatin analogs (SSAs) can lead to normalized GH and IGF-I levels and relief of symptoms. SSA treatment may cause shrinkage of GH-secreting pituitary adenomas. Theoretically, this could improve the likelihood of a radical resection, particularly in macroadenomas. Furthermore, it has been suggested that SSA treatment softens the tumor parenchyma and thereby facilitates tumor removal. Finally, it has been reported that SSA pretreatment leads to a shortening of postoperative hospital stay.
Previous studies addressing preoperative SSA treatment and subsequent surgical cure rates are conflicting, reporting a benefit, or no difference between groups. And most reported studies were rather small and were made in retrospect, we conducted a prospective, randomized study to investigate whether 4-month preoperative lanreotide treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with macroadenomas. We also aimed to investigate whether there were differences in the incidence of surgical complications, and duration of neurosurgical hospital stay.
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Preoperative lanreotide treatment, Transsphenoidal surgery
Department of Neurosurgery, The First Affiliated Hospital of Sun Yat-sen University
Shanghai Jiao Tong University School of Medicine
Published on BioPortfolio: 2014-07-24T14:11:16-0400
The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg with lanreotide 40mg PR in subjects with active acromegaly.
The purpose of this study is to investigate whether 6 months preoperative treatment with the somatostatin analogue octreotide improves the surgical outcome in patients with acromegaly.
Surgery is the primary treatment of acromegaly. However, it often fails to cure the patient. The objective was to investigate whether 6-month preoperative treatment with octreotide improve...
The objectives of the protocol is to determine the maximum tolerated dose and to investigate the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.
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