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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01029275
First received: December 7, 2009
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Acromegaly
Drug: Pre-treatment with octreotide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • IGF1 plasma levels [ Time Frame: 3 months and 12 months after transphenoidal surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GH plasma levels [ Time Frame: 3 and 12 months after transphenoidal surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: January 2005
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029275

Locations
France
Angers University Hospital
Angers, France, 49000
Besançon University Hospital
Besançon, France, 25000
Caen University Hospital
Caen, France, 14000
Grenoble University Hospital
Grenoble, France, 38000
Paris XI University Hospital
Le Kremlin Bicetre, France, 94000
Lille University Hospital
Lille, France, 59000
University Hospital of Limoges
Limoges, France, 87000
Lyon University Hospital
Lyon, France, 69000
Marseille University Hospital
Marseille, France, 13000
Bordeaux University Hospital
Pessac, France, 33000
Rouen University Hospital
Rouen, France, 76000
Strasbourg University Hospital
Strasbourg, France, 67000
Toulouse Universtiy Hospital
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Jean M Kuhn, MD, PhD Rouen University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01029275     History of Changes
Other Study ID Numbers: 2004/089/HP, 2004-004524-12
Study First Received: December 7, 2009
Last Updated: July 30, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Acromegaly
pituitary adenoma
octreotide
transsphenoïdal surgery
GH
IGF-1

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
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 30, 2014