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Somatostatin Analog Treatment of Acromegaly Before Pituitary Surgery : Comparison With Neurosurgery Alone (SAPORO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01029275
First Posted: December 9, 2009
Last Update Posted: July 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
  Purpose
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.

Condition Intervention
Acromegaly Drug: Pre-treatment with octreotide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • IGF1 plasma levels [ Time Frame: 3 months and 12 months after transphenoidal surgery ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 89
Study Start Date: January 2005
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
pre-operative medical treatment with Sandostatin
Drug: Pre-treatment with octreotide
Pre-treatment with octreotide
No Intervention: Arm B
pituitary surgery as a first line treatment

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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029275


Locations
France
Angers University Hospital
Angers, France, 49000
Besançon University Hospital
Besançon, France, 25000
Caen University Hospital
Caen, France, 14000
Grenoble University Hospital
Grenoble, France, 38000
Paris XI University Hospital
Le Kremlin Bicetre, France, 94000
Lille University Hospital
Lille, France, 59000
University Hospital of Limoges
Limoges, France, 87000
Lyon University Hospital
Lyon, France, 69000
Marseille University Hospital
Marseille, France, 13000
Bordeaux University Hospital
Pessac, France, 33000
Rouen University Hospital
Rouen, France, 76000
Strasbourg University Hospital
Strasbourg, France, 67000
Toulouse Universtiy Hospital
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Jean M Kuhn, MD, PhD Rouen University Hospital
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01029275     History of Changes
Other Study ID Numbers: 2004/089/HP
2004-004524-12 ( Registry Identifier: EudraCT )
First Submitted: December 7, 2009
First Posted: December 9, 2009
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by University Hospital, Rouen:
Acromegaly
pituitary adenoma
octreotide
transsphenoïdal surgery
GH
IGF-1

Additional relevant MeSH terms:
Pituitary Diseases
Acromegaly
Pituitary Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents