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

What Was Tested

The trial (not phased) is built around Octreotide.

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.

It had two arms (groups): Arm A (experimental) and Arm B (no intervention).

Pre-operative medical treatment with Sandostatin.

Pituitary surgery as a first line treatment.

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

The registry lists 89 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and women. 18-80 years old. Unsuppressed GH secretion after a glucose load and elevated IGF-1 plasma levels. Presence of a pituitary adenoma on MRI. Informed consent given.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: acromegaly previously treated; contraindication to pituitary surgery; associated hyperprolactinemia above 200 ng/ml.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Octreotide study did not mask who received what.

It started in 2005-01 with completion listed for 2012-01.

It ran at 13 sites in France (13).

What Was Measured

Researchers chose this as the main measure: IGF1 plasma levels (time frame: 3 months and 12 months after transphenoidal surgery).

It also tracked 2 secondary outcomes, for example GH plasma levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Octreotide in 89 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.