Pituitary Apoplexy Surgical Timing & Outcomes Registry (PASTOR)
Research type
Research Study
Full title
Pituitary Apoplexy Surgical Timing & Outcomes Registry (PASTOR)
IRAS ID
243458
Contact name
Nigel Mendoza
Contact email
Sponsor organisation
Cedars-Sinai Medical Center
Clinicaltrials.gov Identifier
Pro00049367, IRB No
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Pituitary apoplexy is a condition where there is bleeding in the pituitary gland. The pituitary is a gland in the brain responsible for maintaining hormone levels in the body. The bleeding causes local tissue death and a constellation of symptoms as there is compression of structures in the skull. Individuals present with sudden visual loss, impairment of eye movements, headache and hormonal dysfunction.
Pituitary apoplexy was previously considered a neurosurgical emergency needing surgical treatment. An alternative approach is medical management in which, surgery is not performed. Previously published cases series have indicated that surgical approaches are more effective than medical management in cases of diminished consciousness, hydrocephalus (increased pressure in the skull), bleeding in other areas of the brain and visual deficit, which has not improved over a few days. Recent evidence has suggested that in the absence of these features, similar outcomes can be achieved without surgery as with surgery.
Other than case series, there are no prospective studies comparing medical management against surgical intervention in cases of pituitary apoplexy. This study encompasses a registry that will collect observational data from cases in the US and UK in order to compare outcomes from cohorts of patients undergoing surgery, versus those who are not. The study will not influence the care of patients, but will record patient demographics, precipitating factors, examination findings, biochemical and imaging findings, surgical metrics where appropriate, histology (where appropriate), hospital stay metrics and follow-up data.
The anonymised observational data collected in the study will be used to compare outcomes between patients who have surgery and those who are medically managed. The comparison will be performed by the study team based in Cedars-Sinai Medical Center.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/0873
Date of REC Opinion
31 May 2018
REC opinion
Unfavourable Opinion