NCT04557072

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,344

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2020

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

1 month

First QC Date

September 17, 2020

Last Update Submit

June 15, 2021

Conditions

Keywords

pheochromocytoma, surgery, alpha-blockade

Outcome Measures

Primary Outcomes (1)

  • Intraoperative maximum systolic blood pressure (mm Hg)

    intraoperative

Secondary Outcomes (13)

  • 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

    intraoperative

  • +8 more secondary outcomes

Study Arms (2)

The selective alpha-blockade group

Patients treated with selective alpha-blockade before pheochromocytoma surgery

Drug: Selective alpha-1-antagonist

The non-selective alpha-blockade group

Patients treated with non-selective alpha-blockade before pheochromocytoma surgery

Drug: Non-selective alpha-1-antagonist

Interventions

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

The selective alpha-blockade group

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

The non-selective alpha-blockade group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Department of General Surgery, Jagiellonian University Medical College

Krakow, Polska, 37-111, Poland

Location

MeSH Terms

Conditions

Pheochromocytoma

Condition Hierarchy (Ancestors)

ParagangliomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2020

First Posted

September 21, 2020

Study Start

August 1, 2020

Primary Completion

September 1, 2020

Study Completion

November 2, 2020

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations