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

NCT ID: NCT01029275

Last Updated: 2014-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2012-01-31

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.

Conditions

Acromegaly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Arm A

pre-operative medical treatment with Sandostatin

Group Type: EXPERIMENTAL

Pre-treatment with octreotide

Intervention Type: DRUG

Pre-treatment with octreotide

Arm B

pituitary surgery as a first line treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pre-treatment with octreotide

Pre-treatment with octreotide

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean M Kuhn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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-Bicêtre, , 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, , France

Countries

France

Other Identifiers

2004-004524-12

Identifier Type: REGISTRY

Identifier Source: secondary_id

2004/089/HP

Identifier Type: -

Identifier Source: org_study_id