PheochromocytomaNCT04557072
Selective Versus Nonselective Alpha-blockade Prior to Pheochromocytoma Resection - Systematic Review and Meta-analysis
An observational study of Pheochromocytoma, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pheochromocytoma
- What is being tested?
- Selective alpha-1-antagonist and Non-selective alpha-1-antagonist
- How many people
- 1,344 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2020to 2 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients who received selective or nonselective alpha-blockade prior to pheochromocytoma resection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
2nd Department of General Surgery, Jagiellonian University Medical College
Krakow, Polska, 37-111
About this study
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.
Read the 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.
- Conditions
- Pheochromocytoma
- Being tested
- Selective alpha-1-antagonist, Non-selective alpha-1-antagonist
- Keywords
- pheochromocytoma, surgery, alpha-blockade
- Medical subject headings
- Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective alpha-1-antagonistDrug
Patients treated with selective alpha-blockade (prazosin, terazosin, doxazosin)
Non-selective alpha-1-antagonistDrug
Patients treated with non-selective alpha-blockade (phenoxybenzamine)
| Study group | Role | What they receive |
|---|---|---|
| The selective alpha-blockade group | Patients treated with selective alpha-blockade before pheochromocytoma surgery Receives: Drug: Selective alpha-1-antagonist | |
| The non-selective alpha-blockade group | Patients treated with non-selective alpha-blockade before pheochromocytoma surgery Receives: Drug: Non-selective alpha-1-antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative maximum systolic blood pressure (mm Hg)
Measured: intraoperative
Secondary outcomes (13)
Frequency of systolic blood pressure >160 mmHg
Measured: intraoperative
Intraoperative maximum diastolic blood pressure (mm Hg)
Measured: intraoperative
intraoperative maximum heart rate (beats/min)
Measured: intraoperative
Intraoperative minimum systolic blood pressure (mm Hg)
Measured: intraoperative
Intraoperative vasopressors administration
(number of patients requiring vasopressors administration)
Measured: intraoperative
Intraoperative vasodilators administration
(number of patients requiring vasopressors administration)
Measured: intraoperative
Operative time (min)
Measured: intraoperative
Overall morbidity
Measured: 30 days
Length of hospital stay (days)
Measured: Up to 30 days
Postoperative minimum systolic blood pressure (mm Hg)
Measured: 24 hours
Postoperative vasopressors administration
(number of patients requiring vasopressors administration)
Measured: 24 hours
Mortality
Measured: 30 days
Time of alpha-adrenolytics administration
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Aug 2020
- Primary completion1 Sep 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolina Zawadzka, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557072
- Sponsor's protocol ID
- SAB vs NAB - pheochromocytoma
- Status last verified
- Jun 2021
- First submitted
- 17 Sep 2020
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Versus Nonselective Alpha-blockade Prior to Pheochromocytoma Resection - Systematic Review and Meta-analysis
- ClinicalTrials.gov ID
- NCT04557072
- Acronym / sponsor ID
- SAB vs NAB - pheochromocytoma
- Conditions
- Pheochromocytoma
- Keywords
- pheochromocytoma, surgery, alpha-blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,344 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The selective alpha-blockade group | – | Drug: Selective alpha-1-antagonistPatients treated with selective alpha-blockade before pheochromocytoma surgery |
| The non-selective alpha-blockade group | – | Drug: Non-selective alpha-1-antagonistPatients treated with non-selective alpha-blockade before pheochromocytoma surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients who received selective or nonselective alpha-blockade prior to pheochromocytoma resection
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective alpha-1-antagonistPatients treated with selective alpha-blockade (prazosin, terazosin, doxazosin) | Drug | The selective alpha-blockade group |
| Non-selective alpha-1-antagonistPatients treated with non-selective alpha-blockade (phenoxybenzamine) | Drug | The non-selective alpha-blockade group |
Primary outcome
Intraoperative maximum systolic blood pressure (mm Hg)
Time frame: intraoperative
13 secondary outcomes
Frequency of systolic blood pressure >160 mmHg
Time frame: intraoperative
Intraoperative maximum diastolic blood pressure (mm Hg)
Time frame: intraoperative
intraoperative maximum heart rate (beats/min)
Time frame: intraoperative
Intraoperative minimum systolic blood pressure (mm Hg)
Time frame: intraoperative
Intraoperative vasopressors administration
Time frame: intraoperative
Intraoperative vasodilators administration
Time frame: intraoperative
Operative time (min)
Time frame: intraoperative
Overall morbidity
Time frame: 30 days
Length of hospital stay (days)
Time frame: Up to 30 days
Postoperative minimum systolic blood pressure (mm Hg)
Time frame: 24 hours
Postoperative vasopressors administration
Time frame: 24 hours
Mortality
Time frame: 30 days
Time of alpha-adrenolytics administration
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pheochromocytoma, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative maximum systolic blood pressure (mm Hg) (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.