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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University Hospital, Rouen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01029275
First received: December 7, 2009
Last updated: August 25, 2011
Last verified: August 2011

December 7, 2009
August 25, 2011
January 2005
December 2011   (final data collection date for primary outcome measure)
IGF1 plasma levels [ Time Frame: 3 months and 12 months after transphenoidal surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029275 on ClinicalTrials.gov Archive Site
  • GH plasma levels [ Time Frame: 3 and 12 months after transphenoidal surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Somatostatin Analog Treatment of Acromegaly Before Pituitary Surgery : Comparison With Neurosurgery Alone
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Acromegaly
  • Drug: Pre-treatment with octreotide
    Pre-treatment with octreotide
  • Other: no treatment before pituitary surgery
    no treatment before pituitary surgery
  • Experimental: Arm A
    pre-operative medical treatment with Sandostatin
    Intervention: Drug: Pre-treatment with octreotide
  • No Intervention: Arm B
    pituitary surgery as a first line treatment
    Intervention: Other: no treatment before pituitary surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01029275
04-089-HP, 2004-004524-12
Yes
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Jean M Kuhn, MD, PhD Rouen University Hospital
University Hospital, Rouen
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP