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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-004524-12 | Registry Identifier | EudraCT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | pre-operative medical treatment with Sandostatin |
|
| Arm B | No Intervention | pituitary surgery as a first line treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-treatment with octreotide | Drug | Pre-treatment with octreotide |
|
| Measure | Description | Time Frame |
|---|---|---|
| IGF1 plasma levels | 3 months and 12 months after transphenoidal surgery |
| Measure | Description | Time Frame |
|---|---|---|
| GH plasma levels | 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. | at transphenoidal surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean M Kuhn, MD, PhD | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers University Hospital | Angers | 49000 | France | |||
| Besançon University Hospital |
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| Besançon |
| 25000 |
| France |
| Caen University Hospital | Caen | 14000 | France |
| Grenoble University Hospital | Grenoble | 38000 | France |
| Paris XI University Hospital | Le Kremlin-Bicêtre | 94000 | France |
| Lille University Hospital | Lille | 59000 | France |
| University Hospital of Limoges | Limoges | 87000 | France |
| Lyon University Hospital | Lyon | 69000 | France |
| Marseille University Hospital | Marseille | 13000 | France |
| Bordeaux University Hospital | Pessac | 33000 | France |
| Rouen University Hospital | Rouen | 76000 | France |
| Strasbourg University Hospital | Strasbourg | 67000 | France |
| Toulouse Universtiy Hospital | Toulouse | 31000 | France |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
| D015173 | Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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