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

Sponsor
Jagiellonian University (Other)
Overall Status
Completed
CT.gov ID
NCT04557072
Collaborator
(none)
1,344
1
3.1
439.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
1344 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Selective Versus Nonselective Alpha-blockade Prior to Pheochromocytoma Resection - Systematic Review and Meta-analysis
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Sep 1, 2020
Actual Study Completion Date :
Nov 2, 2020

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Intraoperative maximum systolic blood pressure (mm Hg) [intraoperative]

Secondary Outcome Measures

  1. Frequency of systolic blood pressure >160 mmHg [intraoperative]

  2. Intraoperative maximum diastolic blood pressure (mm Hg) [intraoperative]

  3. intraoperative maximum heart rate (beats/min) [intraoperative]

  4. Intraoperative minimum systolic blood pressure (mm Hg) [intraoperative]

  5. Intraoperative vasopressors administration [intraoperative]

    (number of patients requiring vasopressors administration)

  6. Intraoperative vasodilators administration [intraoperative]

    (number of patients requiring vasopressors administration)

  7. Operative time (min) [intraoperative]

  8. Overall morbidity [30 days]

  9. Length of hospital stay (days) [Up to 30 days]

  10. Postoperative minimum systolic blood pressure (mm Hg) [24 hours]

  11. Postoperative vasopressors administration [24 hours]

    (number of patients requiring vasopressors administration)

  12. Mortality [30 days]

  13. Time of alpha-adrenolytics administration [Up to 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 2nd Department of General Surgery, Jagiellonian University Medical College Kraków Polska Poland 37-111

Sponsors and Collaborators

  • Jagiellonian University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karolina Zawadzka, Principal Investigator, Jagiellonian University
ClinicalTrials.gov Identifier:
NCT04557072
Other Study ID Numbers:
  • SAB vs NAB - pheochromocytoma
First Posted:
Sep 21, 2020
Last Update Posted:
Jun 18, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Karolina Zawadzka, Principal Investigator, Jagiellonian University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2021