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Phase 3 Completed N=39 Randomized Treatment

Preoperative Alpha Blockade for Pheochromocytoma

Source: ClinicalTrials.gov NCT03176693 ↗
Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Hemodynamic Instability — 14; 13 percentage of total operative time — p=.56
◆ Published Evidence
Highly cited
183citations · ~8 / year
Efficacy and safety of doxazosin for perioperative management of patients with pheochromocytoma.
World journal of surgery · 2002 · High-confidence link

Summary

Pheochromocytoma is a rare, catecholamine (ex. adrenaline) secreting tumor that requires preoperative alpha blockade to minimize intraoperative hemodynamic instability, thereby reducing intra- and postoperative morbidity and mortality. Phenoxybenzamine is a non-selective alpha blocker that is significantly more expensive and is associated with increased adverse effects in comparison with selective alpha blockers such as doxazosin. Retrospective studies show minimal differences in hemodynamic instability and no differences in postoperative morbidity and mortality between selective vs. non-selective alpha blockers. This study is a randomized controlled trial that will compare hemodynamic instability, morbidity, mortality, cost, and quality of life between patients blocked with phenoxybenzamine vs. doxazosin.

Linked Publications (5)

  • Efficacy and safety of doxazosin for perioperative management of patients with pheochromocytoma.
    World journal of surgery · 2002 · 183 citations · High-confidence link
  • Comparison of two preoperative medical management strategies for laparoscopic resection of pheochromocytoma.
    Urology · 2010 · 154 citations · High-confidence link
  • Predictors of hemodynamic instability during surgery for pheochromocytoma.
    Annals of surgical oncology · 2014 · 135 citations · High-confidence link
  • Both preoperative alpha and calcium channel blockade impact intraoperative hemodynamic stability similarly in the management of pheochromocytoma.
    Surgery · 2014 · 92 citations · High-confidence link
  • Selective Versus Non-selective α-Blockade Prior to Laparoscopic Adrenalectomy for Pheochromocytoma.
    Annals of surgical oncology · 2017 · 40 citations · Open access · High-confidence link

Outcome Measures

OutcomeResultp-value
PRIMARY
Hemodynamic Instability
14; 13 .56
SECONDARY
Mortality
0; 0
SECONDARY
Daily Cost of Drug
442.20; 5.06
SECONDARY
Quality of Life- Physical Functioning, Role Limitations Due to Physical Problems, Bodily Pain, General Health Perceptions, Vitality, Social Functioning, Role-limitations Due to Emotional Problems, and Mental Health
SECONDARY
Morbidity as Assessed by Occurrence of Adverse Events
0; 0
SECONDARY
Participants Admitted to Post-operative Intensive Care Unit (ICU)
2; 1

Eligibility Criteria

Inclusion Criteria

  • Adults with pheochromocytoma / paraganglioma undergoing surgical resection

Exclusion Criteria

  • Children < 18 years
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03176693) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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