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| Sponsor: | Shanghai Jiao Tong University School of Medicine |
|---|---|
| Collaborator: |
First Affiliated Hospital, Sun Yat-Sen University |
| Information provided by: | Shanghai Jiao Tong University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00993356 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acromegaly |
Drug: Preoperative lanreotide treatment Procedure: Transsphenoidal surgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized Trial of Preoperative Lanreotide Treatment in Acromegalic Patients With Macroadenomas |
| Estimated Enrollment: | 96 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 2
After a baseline evaluation, patients underwent transsphenoidal surgery (direct surgery group).
|
Procedure: Transsphenoidal surgery |
|
Experimental: Group 1
Patients received lanreotide for 16 weeks before the surgical resection [starting with 30 mg/2 weeks i.m. and increasing to 30 mg/week i.m. at week 8, if mean GH > 5 mU/L on GH day curve (GHDC)] (GHDC: 9×30-min samples collected in the morning after an overnight fast and rest, through an indwelling catheter inserted in an arm vein and while the patient was resting).
|
Drug: Preoperative lanreotide treatment
Patients received lanreotide for 16 weeks before the surgical resection [starting with 30 mg/2 weeks i.m. and increasing to 30 mg/week i.m. at week 8, if mean GH > 5 mU/L on GH day curve (GHDC)] (GHDC: 9×30-min samples collected in the morning after an overnight fast and rest, through an indwelling catheter inserted in an arm vein and while the patient was resting).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Hai-jun Wang, MD | +86-20-88233388 | drhaijun.wang@gmail.com |
| China, Guangdong | |
| Department of Neurosurgery, The First Affiliated Hospital of Sun Yat-sen University | Recruiting |
| Guangzhou, Guangdong, China, 510080 | |
| Contact: Zhi-gang Mao, MD +86-20-88233388 wdy00135033@gmail.com | |
| Contact: Daoyuan Wang, MD +86-13601628114 ghealth2008@gmail.com | |
| Study Director: | Hai-jun Wang, MD | Department of Neurosurgery, The First Affiliated Hospital of Sun Yat-sen University |
More Information
| Responsible Party: | The First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT00993356 History of Changes |
| Other Study ID Numbers: | SUFAH200401A |
| Study First Received: | October 9, 2009 |
| Last Updated: | October 9, 2009 |
| Health Authority: | China: State Food and Drug Administration |
|
Acromegaly Macroadenomas Lanreotide Transsphenoidal neurosurgery Preoperative |
|
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Endocrine System Diseases Lanreotide Angiopeptin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Cardiovascular Agents |