Trial Information

Multicenter, Randomised Open Trial Comparing the Efficacy of a Medical Treatment With Sandostatin LP 30 mg Performed Before Surgery to a Prime Line transsphenoïdal Surgery in Previously Untreated Acromegalic Patients With Either a Micro or a Macro Pituitary Adenoma

Somatotroph pituitary adenoma is the most frequent cause of acromegaly. A transsphenoidal
removal of the tumor is used as the first line treatment. Somatostatin analogs are used as
to whether recovery was not obtained after surgery or pituitary surgery was contraindicated.
Previous studies with somatostatin analogs have shown a drop in plasma GH and IGF-1 levels
and a reduction in adenoma size in 75 and 25% of patients respectively. Retrospective
studies suggest that a treatment with somatostatin analogs performed before surgery may be
of interest to improve anesthesic conditions and surgical outcome. The aim of present study
is to prospectively evaluate the interest of a first line treatment with a long-acting
somatostatin analog (Sandostatin) before performing a pituitary surgery in acromegalic
patients with either a micro or a macroadenoma to improve peri-operative conditions and
hopefully surgical outcome. After informed consent, untreated acromegalic patients will be
included and randomly assigned to one of the following treatment procedures : either
pituitary surgery or a six month treatment with long-acting Sandostatin 30 mg monthly for 6
months before performing transsphenoïdal adenoma removal. The patients will be evaluated
before any treatment, on months 3 and 6 of the treatment with Sandostatin (for the patients
enrolled in this arm of the study) and on months 3 and 12 after pituitary neurosurgery. Each
evaluation will include clinical data, hormone testing and radiological (MRI) investigation.
The main endpoint will be the rate of recovery proved by a normalisation of GH secretion and
plasma IGF-1 level. Secondary endpoints will include the evaluation of clinical,
radiological, biological, anesthesic, surgical and pathological parameters. A comparison
between the two arms will be performed at entry into the study, at the time of surgery and
then on months 3 and 12 following the transsphenoidal removal of the somatotroph adenoma.