Preoperative Octreotide Treatment of Acromegaly

St. Olavs Hospital62 enrolled

Overview

The purpose of this study is to investigate whether 6 months preoperative treatment with the somatostatin analogue octreotide improves the surgical outcome in patients with acromegaly.

After a baseline evaluation, patients are randomized separately for each study center in blocks of four directly to transsphenoidal surgery or to 6-month preoperative treatment with octreotide. To reduce the risk of gastrointestinal adverse effects in the pretreatment group, octreotide is initiated at a dose of 50 µg sc three times a day for the 1st week and 100 µg sc three times a day for the 2nd week. From the 3rd week on, the patients receive octreotide LAR (Novartis International AG, Basel, Switzerland) 20 mg im every 28th day for 6 months. Patients receive transsphenoidal surgery within 28 d of the last injection. If surgery are delayed, an extra octreotide LAR injection is given before surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acromegaly

Interventions

OctreotideDRUG

First week: Octreotide 50 micrograms subcutaneously three times daily. Second week: Octreotide 100 micrograms subcutaneously three times daily. From the third week on: Octreotide LAR 20 mg intramuscularly every 28th day for 6 months

Direct surgery for acromegalyPROCEDURE

Direct transsphenoidal surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * GH nadir during a standard 75 g OGTT \>= 5.0 mmol/L. * Pituitary tumor by MRI-scan. Exclusion Criteria: * Immediate surgery indicated by usual clinical criteria. * Pregnant. * Known adverse effects of octreotide. * Unfit for participation by any other reason.

Locations (5)

Endocrinology Unit, Department of Medicine, Haukeland University Hospital

Bergen, Norway

Endocrinology Unit, Department of Medicine, Aker University Hospital

Oslo, Norway

Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center

Oslo, Norway

Endocrinology Unit, Department of Medicine, University Hospital of North Norway

Tromsø, Norway

Outcomes

Primary Outcomes

Surgical cure by transsphenoidal surgery

Time frame: Primarily 3 months postoperatively, but up to 10 years postoperatively

Secondary Outcomes

Effect of treatment on surgical complications and duration of hospital stay, pituitary function, quality of life, and the need for postsurgical medical treatment of acromegaly

Time frame: Primarily 3 months postoperatively, but up to 10 years postoperatively

Data from ClinicalTrials.gov

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