Brief Title
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
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.
Study Type
Interventional
Primary Outcome
IGF1 plasma levels
Secondary Outcome
GH plasma levels
Condition
Acromegaly
Intervention
Pre-treatment with octreotide
Study Arms / Comparison Groups
Arm A
Description: pre-operative medical treatment with Sandostatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
89
Start Date
January 2005
Completion Date
January 2012
Primary Completion Date
January 2012
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Jean M Kuhn, MD, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01029275
Organization ID
2004/089/HP
Secondary IDs
2004-004524-12
Responsible Party
Sponsor
Study Sponsor
University Hospital, Rouen
Study Sponsor
Jean M Kuhn, MD, PhD, Principal Investigator, Rouen University Hospital
Verification Date
July 2014