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

July 30, 2014 updated by: University Hospital, Rouen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • Angers University Hospital
      • Besançon, France, 25000
        • Besançon University Hospital
      • Caen, France, 14000
        • CAEN University Hospital
      • Grenoble, France, 38000
        • Grenoble University Hospital
      • Le Kremlin Bicetre, France, 94000
        • Paris XI University Hospital
      • Lille, France, 59000
        • Lille University Hospital
      • Limoges, France, 87000
        • University Hospital of Limoges
      • Lyon, France, 69000
        • Lyon university hospital
      • Marseille, France, 13000
        • Marseille University Hospital
      • Pessac, France, 33000
        • Bordeaux University Hospital
      • Rouen, France, 76000
        • Rouen University Hospital
      • Strasbourg, France, 67000
        • Strasbourg University Hospital
      • Toulouse, France, 31000
        • Toulouse Universtiy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
pre-operative medical treatment with Sandostatin
Drug: Pre-treatment with octreotide
Pre-treatment with octreotide
No Intervention: Arm B
pituitary surgery as a first line treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IGF1 plasma levels
Time Frame: 3 months and 12 months after transphenoidal surgery
3 months and 12 months after transphenoidal surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
GH plasma levels
Time Frame: 3 and 12 months after transphenoidal surgery
3 and 12 months after transphenoidal surgery
Evaluation of the effects of the pre-operative treatment with Sandostatin on clinical, radiological, biological, anesthesic, surgical and pathological parameters.
Time Frame: at transphenoidal surgery
at transphenoidal surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004/089/HP
  • 2004-004524-12 (Registry Identifier: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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