Selective Versus Nonselective Alpha-blockade Prior to Pheochromocytoma Resection - Systematic Review and Meta-analysis

Our aim was to systematically evaluate the current data on the efficacy of pretreatment with either selective or nonselective alpha-blockade on the hemodynamic instability and morbidity during pheochromocytoma resection.

Study Overview

• Status: Completed
• Conditions: Pheochromocytoma
• Intervention / Treatment: Drug: Selective alpha-1-antagonist; Drug: Non-selective alpha-1-antagonist

Detailed Description

RCTs and non-randomized controlled studies comparing preoperative selective alpha-blockade (SAB) with nonselective alpha-blockade (NAB) in pheochromocytoma surgery in adults were eligible for inclusion.

All identified articles will be screened by title and abstract. Two independent reviewers will review potentially relevant articles in detail. Dissent will be resolved by consensus and the recommendation of a third observer as required. Data from the included studies will be extracted independently by the two researchers. The Meta-analysis Of Observational Studies in Epidemiology (MOOSE) guidelines will be used for reporting.

Quality of Assessment The Risk Of Bias In Non-randomized Studies - of Interventions (ROBINS-I) tool will be used to assess the quality of included non-randomized studies. The risk of bias of randomized studies will be assessed using the criteria described in the Cochrane Handbook for Systematic Reviews of Interventions .The quality of each study will be assessed by two of the authors. In the event of uncertainties regarding the levels of the studies' quality, a third reviewer will be consulted.

Analysis will be performed using RevMan (Version 5.3, freeware from the Cochrane Collaboration). Odds ratios and their associated 95% confidence intervals will be pooled for dichotomous outcomes using the Mantel-Haenszel random-effects method. Continuous outcomes will be pooled as weighted mean difference (WMD) with 95 per cent confidence interval using the inverse-variance random-effects method. WMD and OR will be presented on the graphs as squares, and pooled WMD and OR will be presented as diamond.

P ≤ 0.05 will be considered a statistically significant difference for hypothesis and P < 0.10 for heterogeneity testing, respectively.

Heterogeneity between the studies will be estimated by statistical tests I2 and Cochran's Q tests.

• Study Type: Observational
• Enrollment (Actual): 1344

Contacts and Locations

Study Locations

• Poland
  • Polska
    • Kraków, Polska, Poland, 37-111
      • 2nd Department of General Surgery, Jagiellonian University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

RCTs and non-randomized controlled studies comparing preoperative selective α-blockade (SAB) with nonselective α-blockade (NAB) in pheochromocytoma surgery in adults were eligible for inclusion.

Description

Inclusion Criteria:

• All patients who received selective or nonselective alpha-blockade prior to pheochromocytoma resection

Exclusion Criteria:

• Patients who did not receive alpha blockade
• Patients not undergoing surgery
• No comparison for selective and non-selective pretreatment in the study
• Studies without primary or sufficient data (reviews, guidelines, meeting abstracts, letters),
• Studies reported in a language other than English

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The selective alpha-blockade group; Patients treated with selective alpha-blockade before pheochromocytoma surgery	Drug: Selective alpha-1-antagonist; Patients treated with selective alpha-blockade (prazosin, terazosin, doxazosin)
The non-selective alpha-blockade group; Patients treated with non-selective alpha-blockade before pheochromocytoma surgery	Drug: Non-selective alpha-1-antagonist; Patients treated with non-selective alpha-blockade (phenoxybenzamine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraoperative maximum systolic blood pressure (mm Hg)	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		30 days
Length of hospital stay (days)		Up to 30 days
Frequency of systolic blood pressure >160 mmHg		intraoperative
Intraoperative maximum diastolic blood pressure (mm Hg)		intraoperative
intraoperative maximum heart rate (beats/min)		intraoperative
Intraoperative minimum systolic blood pressure (mm Hg)		intraoperative
Intraoperative vasopressors administration	(number of patients requiring vasopressors administration)	intraoperative
Intraoperative vasodilators administration	(number of patients requiring vasopressors administration)	intraoperative
Operative time (min)		intraoperative
Overall morbidity		30 days
Postoperative minimum systolic blood pressure (mm Hg)		24 hours
Postoperative vasopressors administration	(number of patients requiring vasopressors administration)	24 hours
Time of alpha-adrenolytics administration		Up to 30 days

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ACTUAL): November 2, 2020

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (ACTUAL): September 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: pheochromocytoma, surgery, alpha-blockade
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Paraganglioma; Pheochromocytoma
• Other Study ID Numbers: SAB vs NAB - pheochromocytoma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No