An interventional study of Pre-treatment with octreotide in Acromegaly, sponsored by University Hospital, Rouen. Completed at 13 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-07-31.
Sponsored by University Hospital, Rouen · Not applicable and Interventional
The aim of the study is to evaluate the interest of a six month pre-operative treatment with a long-acting somatostatin analog (Sandostatin LP) versus surgery alone in patients with a pituitary adenoma responsible for acromegaly.
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.
196 studies on the registry are indexed under Acromegaly; 18 are open to participants now.
This study's enrollment of 89 is above the median of 43 across 115 interventional studies indexed under Acromegaly.
Browse Acromegaly studies →University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
pre-operative medical treatment with Sandostatin
Drug: Pre-treatment with octreotide
pituitary surgery as a first line treatment
Pre-treatment with octreotide
IGF1 plasma levels
Time frame: 3 months and 12 months after transphenoidal surgery
GH plasma levels
Time frame: 3 and 12 months after transphenoidal surgery
Evaluation of the effects of the pre-operative treatment with Sandostatin on clinical, radiological, biological, anesthesic, surgical and pathological parameters.
Time frame: at transphenoidal surgery
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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University Hospital, Rouen