Brief Title
Preoperative Lanreotide Treatment in Acromegalic Patients With Macroadenomas
Official Title
A Prospective, Randomized Trial of Preoperative Lanreotide Treatment in Acromegalic Patients With Macroadenomas
Brief Summary
Previous studies addressing preoperative somatostatin analogs (SSA) treatment and subsequent surgical cure rates are conflicting, reporting a benefit, or no difference between groups. And most reported studies were rather small and were made in retrospect, we conducted a prospective, randomized study to investigate whether 4-month preoperative lanreotide treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with macroadenomas. The investigators also aimed to investigate whether there were differences in the incidence of surgical complications, and duration of neurosurgical hospital stay.
Detailed Description
Acromegaly is a rare disease, caused by a growth hormone (GH)-secreting adenoma and in even more seldom instances (about 1%) due to excessive growth hormone-releasing hormone (GHRH) secretion, usually by a carcinoid tumor of the lung or gastrointestinal tract. The incidence of acromegaly is about 3-4 per 1 million per year and the prevalence is 60-70 per 1 million, without geographical or sex differences. Clinical features of acromegaly include acral enlargement, prognathism, jaw malocclusion, arthropathy, carpal tunnel syndrome, hyperhydrosis, sleep apnea, and visceromegaly. Transsphenoidal neurosurgery, allowing selective removal of the pituitary adenoma, is the current first treatment for acromegaly in the majority of patients. Its effects on GH and insulin-like growth factor I (IGF-I) secretion are rapid and operations have a low morbidity and very low mortality. However, surgery for macroadenomas causing acromegaly has a much lower surgical success rate than that for microadenomas. In experienced hands, microadenomas can be expected to be cured in around 90%, whereas with macroadenomas the figure is around 50%. This is particularly the case with tumours that extend into the cavernous sinus where surgical success is < 50%. Medical treatment of acromegaly with somatostatin analogs (SSAs) can lead to normalized GH and IGF-I levels and relief of symptoms. SSA treatment may cause shrinkage of GH-secreting pituitary adenomas. Theoretically, this could improve the likelihood of a radical resection, particularly in macroadenomas. Furthermore, it has been suggested that SSA treatment softens the tumor parenchyma and thereby facilitates tumor removal. Finally, it has been reported that SSA pretreatment leads to a shortening of postoperative hospital stay. Previous studies addressing preoperative SSA treatment and subsequent surgical cure rates are conflicting, reporting a benefit, or no difference between groups. And most reported studies were rather small and were made in retrospect, we conducted a prospective, randomized study to investigate whether 4-month preoperative lanreotide treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with macroadenomas. We also aimed to investigate whether there were differences in the incidence of surgical complications, and duration of neurosurgical hospital stay.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Cure rate at evaluation 4 months postoperatively
Secondary Outcome
Postoperative hospital stay duration
Condition
Acromegaly
Intervention
Preoperative lanreotide treatment
Study Arms / Comparison Groups
Group 2
Description: After a baseline evaluation, patients underwent transsphenoidal surgery (direct surgery group).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
96
Start Date
January 2004
Completion Date
December 2010
Primary Completion Date
December 2009
Eligibility Criteria
Inclusion Criteria: - patients with newly diagnosed acromegaly due to GH-secreting macro-adenomas. - newly diagnosed, previously untreated patients with GH nadir more than 2.5 μg/L during a standard 75-g, 2-h oral glucose tolerance test (OGTT) - pituitary macroadenomas (maximum diameter >1 cm) verified by a pituitary magnetic resonance imaging (MRI) scan - age between 18 and 80 yr. Exclusion Criteria: - immediate surgery indicated by clinical criteria - pregnancy - contraindications to MRI scan - patients judged not suitable to participate in the study for other reasons such as personality disorders and alcohol abuse.
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Hai-jun Wang, MD, +86-20-88233388, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT00993356
Organization ID
SUFAH200401A
Study Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Study Sponsor
Hai-jun Wang, MD, Study Director, Department of Neurosurgery, The First Affiliated Hospital of Sun Yat-sen University
Verification Date
October 2009