Somatostatin Analog Treatment of Acromegaly Before Pituitary Surgery : Comparison With Neurosurgery Alone
SAPORO
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
2 other identifiers
interventional
89
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2005
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 7, 2009
CompletedFirst Posted
Study publicly available on registry
December 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJuly 31, 2014
July 1, 2014
7 years
December 7, 2009
July 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IGF1 plasma levels
3 months and 12 months after transphenoidal surgery
Secondary Outcomes (2)
GH plasma levels
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.
at transphenoidal surgery
Study Arms (2)
Arm A
EXPERIMENTALpre-operative medical treatment with Sandostatin
Arm B
NO INTERVENTIONpituitary surgery as a first line treatment
Interventions
Eligibility Criteria
You may qualify if:
- men and women
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Angers University Hospital
Angers, 49000, France
Besançon University Hospital
Besançon, 25000, France
Caen University Hospital
Caen, 14000, France
Grenoble University Hospital
Grenoble, 38000, France
Paris XI University Hospital
Le Kremlin-Bicêtre, 94000, France
Lille University Hospital
Lille, 59000, France
University Hospital of Limoges
Limoges, 87000, France
Lyon University Hospital
Lyon, 69000, France
Marseille University Hospital
Marseille, 13000, France
Bordeaux University Hospital
Pessac, 33000, France
Rouen University Hospital
Rouen, 76000, France
Strasbourg University Hospital
Strasbourg, 67000, France
Toulouse Universtiy Hospital
Toulouse, 31000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean M Kuhn, MD, PhD
University Hospital, Rouen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2009
First Posted
December 9, 2009
Study Start
January 1, 2005
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
July 31, 2014
Record last verified: 2014-07