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

Acromegaly Clinical Trial

— SAPORO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029275
• Other study ID #: 2004/089/HP
• Secondary ID: 2004-004524-12
• Status: Completed
• Phase: N/A
• First received: December 7, 2009
• Last updated: July 30, 2014
• Start date: January 2005
• Est. completion date: January 2012

Study information

• Verified date: July 2014
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Pre-treatment with octreotide
Pre-treatment with octreotide

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Besançon University Hospital	Besançon
France	Caen University Hospital	Caen
France	Grenoble University Hospital	Grenoble
France	Paris XI University Hospital	Le Kremlin Bicetre
France	Lille University Hospital	Lille
France	University Hospital of Limoges	Limoges
France	Lyon University Hospital	Lyon
France	Marseille University Hospital	Marseille
France	Bordeaux University Hospital	Pessac
France	Rouen University Hospital	Rouen
France	Strasbourg University Hospital	Strasbourg
France	Toulouse Universtiy Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IGF1 plasma levels		3 months and 12 months after transphenoidal surgery	No
Secondary	GH plasma levels		3 and 12 months after transphenoidal surgery	No
Secondary	Evaluation of the effects of the pre-operative treatment with Sandostatin on clinical, radiological, biological, anesthesic, surgical and pathological parameters.		at transphenoidal surgery	No