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Completed

NCT Number: NCT04557072

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.

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Key information

Conditions

Pheochromocytoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Paraganglioma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

2nd Department of General Surgery, Jagiellonian University Medical College

Krakow, Polska, 37-111, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selective alpha-1-antagonist

Drug

Patients treated with selective alpha-blockade (prazosin, terazosin, doxazosin)

Non-selective alpha-1-antagonist

Drug

Patients treated with non-selective alpha-blockade (phenoxybenzamine)

Primary outcomes

  1. Intraoperative maximum systolic blood pressure (mm Hg)

    Time frame: intraoperative

Secondary outcomes

  1. Frequency of systolic blood pressure >160 mmHg

    Time frame: intraoperative

  2. Intraoperative maximum diastolic blood pressure (mm Hg)

    Time frame: intraoperative

  3. intraoperative maximum heart rate (beats/min)

    Time frame: intraoperative

  4. Intraoperative minimum systolic blood pressure (mm Hg)

    Time frame: intraoperative

  5. Intraoperative vasopressors administration

    Time frame: intraoperative

    (number of patients requiring vasopressors administration)

  6. Intraoperative vasodilators administration

    Time frame: intraoperative

    (number of patients requiring vasopressors administration)

  7. Operative time (min)

    Time frame: intraoperative

  8. Overall morbidity

    Time frame: 30 days

  9. Length of hospital stay (days)

    Time frame: Up to 30 days

  10. Postoperative minimum systolic blood pressure (mm Hg)

    Time frame: 24 hours

  11. Postoperative vasopressors administration

    Time frame: 24 hours

    (number of patients requiring vasopressors administration)

  12. Mortality

    Time frame: 30 days

  13. Time of alpha-adrenolytics administration

    Time frame: Up to 30 days

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2020
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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