Surgical Debulking of Pituitary Adenomas

What Was Tested

This registered phase 4 trial tested Octreotide.

All patients will undergo transsphenoidal hypophysectomy.

It had two arms (groups): Medical treatment by Octreotide LAR (active comparator) and Surgical debulking followed by Octreotide LAR (active comparator).

The registry classes the interventions as drug and procedure.

More on the Plan

The current goal of treatment for people with acromegaly is normalization of both growth hormone (GH) and insulin-like-growth-factor-1 (IGF-1) levels.

The optimal approach to achieving these goals in patients with pituitary macroadenomas remains controversial.

Available treatment modalities include transsphenoidal hypophysectomy, medical therapy (somatostatin analogues and/or dopaminergic agonists), radiotherapy, or a combination or these interventions.

Who Took Part

Enrollment: 41 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Have a pituitary macroadenoma. Have clinical changes consistent with acromegaly. Have a single random serum hGH of 12.5 ng/ml or greater. Patients currently on dopamine agonist who agree to discontinue medication (2-6 week washout required).

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: pregnant or breastfeeding; documented loss of vision due to pituitary tumor; prior treatment for acromegaly other than dopamine agonists.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

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 2004-04 with completion listed for 2010-07.

It ran at 1 site in United States.

What Was Measured

The main thing measured (primary outcome): Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2) (time frame: 3 months). Percentage of Responders (All Treatments) (time frame: 3 months).

It also tracked 1 secondary outcome, for example Percentage of Responders (Only Including Surgical Failures in Arm 2).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 41 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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