Somatostatin Analog Treatment of Acromegaly Before Pituitary Surgery : Comparison With Neurosurgery Alone

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Somatostatin Analog Treatment of Acromegaly Before Pituitary Surgery : Comparison With Neurosurgery Alone

Official Title

Multicenter, Randomised Open Trial Comparing the Efficacy of a Medical Treatment With Sandostatin LP 30 mg Performed Before Surgery to a Prime Line transsphenoïdal Surgery in Previously Untreated Acromegalic Patients With Either a Micro or a Macro Pituitary Adenoma

Brief Summary

      The aim of the study is to evaluate the interest of a six month pre-operative treatment with
      a long-acting somatostatin analog (Sandostatin LP) versus surgery alone in patients with a
      pituitary adenoma responsible for acromegaly.

Detailed Description

      Somatotroph pituitary adenoma is the most frequent cause of acromegaly. A transsphenoidal
      removal of the tumor is used as the first line treatment. Somatostatin analogs are used as to
      whether recovery was not obtained after surgery or pituitary surgery was contraindicated.
      Previous studies with somatostatin analogs have shown a drop in plasma GH and IGF-1 levels
      and a reduction in adenoma size in 75 and 25% of patients respectively. Retrospective studies
      suggest that a treatment with somatostatin analogs performed before surgery may be of
      interest to improve anesthesic conditions and surgical outcome. The aim of present study is
      to prospectively evaluate the interest of a first line treatment with a long-acting
      somatostatin analog (Sandostatin) before performing a pituitary surgery in acromegalic
      patients with either a micro or a macroadenoma to improve peri-operative conditions and
      hopefully surgical outcome. After informed consent, untreated acromegalic patients will be
      included and randomly assigned to one of the following treatment procedures : either
      pituitary surgery or a six month treatment with long-acting Sandostatin 30 mg monthly for 6
      months before performing transsphenoïdal adenoma removal. The patients will be evaluated
      before any treatment, on months 3 and 6 of the treatment with Sandostatin (for the patients
      enrolled in this arm of the study) and on months 3 and 12 after pituitary neurosurgery. Each
      evaluation will include clinical data, hormone testing and radiological (MRI) investigation.
      The main endpoint will be the rate of recovery proved by a normalisation of GH secretion and
      plasma IGF-1 level. Secondary endpoints will include the evaluation of clinical,
      radiological, biological, anesthesic, surgical and pathological parameters. A comparison
      between the two arms will be performed at entry into the study, at the time of surgery and
      then on months 3 and 12 following the transsphenoidal removal of the somatotroph adenoma.

Study Type

Interventional

Primary Outcome

IGF1 plasma levels

Secondary Outcome

 GH plasma levels

Condition

Acromegaly

Intervention

Pre-treatment with octreotide

Study Arms / Comparison Groups

 Arm A
Description:  pre-operative medical treatment with Sandostatin

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

89

Start Date

January 2005

Completion Date

January 2012

Primary Completion Date

January 2012

Eligibility Criteria

        Inclusion Criteria:

          -  men and women

          -  18-80 years old

          -  untreated acromegaly

          -  unsuppressed GH secretion after a glucose load and elevated IGF-1 plasma levels

          -  presence of a pituitary adenoma on MRI

          -  informed consent given.

        Exclusion Criteria:

          -  acromegaly previously treated

          -  contraindication to pituitary surgery

          -  associated hyperprolactinemia above 200 ng/ml

          -  visual field defect needing rapid transsphenoidal surgery

          -  contraindication to a treatment with octreotide

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Jean M Kuhn, MD, PhD, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT01029275

Organization ID

2004/089/HP

Secondary IDs

2004-004524-12

Responsible Party

Sponsor

Study Sponsor

University Hospital, Rouen

Study Sponsor

Jean M Kuhn, MD, PhD, Principal Investigator, Rouen University Hospital

Verification Date

July 2014