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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 2 | Other | After a baseline evaluation, patients underwent transsphenoidal surgery (direct surgery group). |
|
| Group 1 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative lanreotide treatment | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate at evaluation 4 months postoperatively | every 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative hospital stay duration | every 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hai-jun Wang, MD | Contact | +86-20-88233388 | drhaijun.wang@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hai-jun Wang, MD | Department of Neurosurgery, The First Affiliated Hospital of Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21138567 | Derived | Mao ZG, He DS, Zhou J, Yao B, Xiao WW, Chen CH, Zhu YH, Wang HJ. Differential expression of microRNAs in GH-secreting pituitary adenomas. Diagn Pathol. 2010 Dec 7;5:79. doi: 10.1186/1746-1596-5-79. | |
| 20061334 | Derived | Mao ZG, Zhu YH, Tang HL, Wang DY, Zhou J, He DS, Lan H, Luo BN, Wang HJ. Preoperative lanreotide treatment in acromegalic patients with macroadenomas increases short-term postoperative cure rates: a prospective, randomised trial. Eur J Endocrinol. 2010 Apr;162(4):661-6. doi: 10.1530/EJE-09-0908. Epub 2010 Jan 8. |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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|
| Transsphenoidal surgery | Procedure |
|
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |