Trial Information
Pheochromocytoma Randomised Study Comparing Adrenoreceptor Inhibiting Agents for Preoperative Treatment
Inclusion Criteria:
- age > 18 years
- diagnosis of benign Pheochromocytoma (adrenal or extra-adrenal, sporadic or
hereditary:
- hypertension
- elevated plasma and/or urinary (nor)metanephrines. From each patient, a blood
sample is collected for measurement of plasma (nor)metanephrines with the
reference laboratory assay (i.e. XLC-MS/MS) at the Department of Laboratory
Medicine of the UMCG.
- localisation of PCC by anatomical (MRI/CT) and functional imaging (I123-MIBG
scintigraphy or 18F-DOPA PET)
- planned for surgical removal of the PCC
Exclusion Criteria:
- age < 18 years
- malignant PCC, i.e. presence of lesions on imaging studies suggestive of distant
metastases
- severe hemodynamic instability before surgery necessitating admission to intensive
care unit
- pregnancy
- incapability to adhere to the study protocol
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The number of patients demonstrating more than three intraoperative episodes of 5 minutes with blood pressure outside the predefined target range after pretreatment with either phenoxybenzamine or doxazosin.
Outcome Description:
Blood pressure and heart rate will be monitored at 5 minute intervals during surgery.
Outcome Time Frame:
Duration of surgery, i.e. on average 3 hours
Safety Issue:
No
Principal Investigator
Michiel N. Kerstens, MD PhD
Investigator Role:
Study Director
Investigator Affiliation:
University Medical Centre Groningen
Authority:
Netherlands: Medical Ethics Review Committee (METC)
Study ID:
PRESCRIPT2010.369
NCT ID:
NCT01379898
Start Date:
December 2011
Completion Date:
December 2014
Related Keywords:
- Pheochromocytoma
- Pheochromocytoma
- Doxazosin
- Phenoxybenzamine
- Pheochromocytoma