Acromegaly Clinical Trial
Official title:
A Prospective, Randomized Trial of Preoperative Lanreotide Treatment in Acromegalic Patients With Macroadenomas
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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