Clinical trial NCT01029275: Somatostatin Analog Treatment of Acromegaly Before Pituitary Surgery : Comparison With Neurosurgery Alone
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acromegaly
Keywords: Acromegaly
pituitary adenoma
octreotide
transsphenoïdal surgery
GH
IGF-1
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* men and women
* 18-80 years old
* untreated acromegaly
* unsuppressed GH secretion after a glucose load and elevated IGF-1 plasma levels
* presence of a pituitary adenoma on MRI
* informed consent given.

Exclusion Criteria:

* acromegaly previously treated
* contraindication to pituitary surgery
* associated hyperprolactinemia above 200 ng/ml
* visual field defect needing rapid transsphenoidal surgery
* contraindication to a treatment with octreotide

Primary outcomes:
measure: IGF1 plasma levels
timeFrame: 3 months and 12 months after transphenoidal surgery
Secondary outcomes:
measure: GH plasma levels
timeFrame: 3 and 12 months after transphenoidal surgery
measure: Evaluation of the effects of the pre-operative treatment with Sandostatin on clinical, radiological, biological, anesthesic, surgical and pathological parameters.
timeFrame: at transphenoidal surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Besançon
country: France
facility: Besançon University Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Le Kremlin Bicetre
country: France
facility: Paris XI University Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Limoges
country: France
facility: University Hospital of Limoges
city: Lyon
country: France
facility: Lyon University Hospital
city: Marseille
country: France
facility: Marseille University Hospital
city: Pessac
country: France
facility: Bordeaux University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Toulouse
country: France
facility: Toulouse Universtiy Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Jean M Kuhn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: