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Pheochromocytoma Randomised Study Comparing Adrenoreceptor Inhibiting Agents for Preoperative Treatment


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Pheochromocytoma

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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

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