Preoperative Octreotide Treatment of Acromegaly

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: Octreotide
* Procedure: Direct surgery for acromegaly


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: octreotide<br>6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly | Drug: Octreotide<br>* 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<br>* Other names: Sandostatin LAR;|
| Active Comparator: standard surgery<br>Standard transphenoidal surgery soon after the diagnosis of acromegaly | Procedure: Direct surgery for acromegaly<br>* Direct transsphenoidal surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical cure by transsphenoidal surgery |  | Primarily 3 months postoperatively, but up to 10 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Primarily 3 months postoperatively, but up to 10 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acromegaly