Preoperative Lanreotide Treatment in Acromegalic Patients With Macroadenomas

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
First Affiliated Hospital, Sun Yat-Sen University
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00993356
First received: October 9, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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 2

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

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Cure rate at evaluation 4 months postoperatively [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative hospital stay duration [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]

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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00993356

Contacts
Contact: Hai-jun Wang, MD +86-20-88233388 drhaijun.wang@gmail.com

Locations
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   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Study Director: Hai-jun Wang, MD Department of Neurosurgery, The First Affiliated Hospital of Sun Yat-sen University
  More Information

No publications provided by Shanghai Jiao Tong University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Acromegaly
Macroadenomas
Lanreotide
Transsphenoidal neurosurgery
Preoperative

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on October 19, 2014