Preoperative Lanreotide Treatment in Acromegalic Patients With Macroadenomas

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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