Preoperative Octreotide Treatment of Acromegaly (POTA)

St. Olavs Hospital

Status and phase: Completed; Phase 4

Conditions: Acromegaly

Treatments: Procedure: Direct surgery for acromegaly; Drug: Octreotide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00521300

SLKNR 98-5560 (Other Identifier)

S-71-98 (REK)

S-71-98 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

octreotide

Experimental group

Description:

6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly

Treatment:

Drug: Octreotide

standard surgery

Active Comparator group

Description:

Standard transphenoidal surgery soon after the diagnosis of acromegaly

Treatment:

Procedure: Direct surgery for acromegaly