Preoperative Octreotide Treatment of Acromegaly
Information source: St. Olavs Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acromegaly
Intervention: Octreotide (Drug); Direct surgery for acromegaly (Procedure); Preoperative octreotide treatment before transsphenoidal surgery for acromegaly (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: St. Olavs Hospital Official(s) and/or principal investigator(s):
Sven M Carlsen, MD, PhD, Principal Investigator, Affiliation: Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway
Summary
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.
Clinical Details
Official title: Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Surgical cure by transsphenoidal surgery
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Department of Endocrinology, St. Olavs Hospital, Trondheim 7006, Norway
Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center, Oslo, Norway
Endocrinology Unit, Department of Medicine, Aker University Hospital, Oslo, Norway
Endocrinology Unit, Department of Medicine, Haukeland University Hospital, Bergen, Norway
Endocrinology Unit, Department of Medicine, University Hospital of North Norway, Tromsø, Norway
Additional Information
Starting date: September 1999
Ending date: May 2015
Last updated: August 24, 2007
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