Adrenal PheochromocytomaNCT05803330
Study of Alpha-blockers Alone During Preoperative Preparation in Patients With Pheochromocytoma
A study testing Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytoma in people with Adrenal Pheochromocytoma and Hemodynamic, run by Kunwu Yan,MM.
Trial summary
Study of the relationship between hemodynamic stability and preoperative intravenous rehydration in patients with pheochromocytoma Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Adrenal Pheochromocytoma, Hemodynamic
- What is being tested?
- Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytoma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2014to 20 Oct 2022
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of adrenal pheochromocytoma Must be able to swallow tablets
Who cannot join
- Bilateral or multiple pheochromocytomas. Ectopic pheochromocytoma
About this study
Official title: Clinical Study of Abandonment of Intravenous Volume Expansion After Preoperative Use of α-blockers in Patients With Adrenal Pheochromocytoma
Study of the relationship between hemodynamic stability and preoperative intravenous rehydration in patients with pheochromocytoma
Read the detailed description
All patients were subclassified into either the hemodynamic stability group (HS group) or the hemodynamic instability group (HU group) according to whether intraoperative hemodynamic instability occurred. Differences in data between the two groups were examined, and the risk factors for intraoperative hemodynamic instability were analyzed using logistic regression.
- Conditions
- Adrenal Pheochromocytoma, Hemodynamic
- Being tested
- Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytoma
- Medical subject headings
- Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytomaDrug
Abandonment of intravenous volume expansion with alpha-blockers during preoperative preparation in patients with pheochromocytoma
| Study group | Role | What they receive |
|---|---|---|
| PXB combined with venous dilation group | No intervention | Use of PXB combined with intravenous volume expansion during preoperative preparation in patients with pheochromocytoma |
| PXB group | Experimental | PXB alone during preoperative preparation in patients with pheochromocytoma Receives: Drug: Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative mean arterial pressure
an intraoperative mean arterial pressure <60 mmHg is considered to be hemodynamically unstable
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start20 Feb 2014
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adrenal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kunwu Yan,MM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kunwu Yan,MM, Handan First Hospital
- Investigators
- kunwu yan, Master, Principal investigator, Handan First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803330
- Sponsor's protocol ID
- 202303-1
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meijs AC, Snel M, Corssmit EPM. Pheochromocytoma/paraganglioma crisis: case series from a tertiary referral center for pheochromocytomas and paragangliomas. Hormones (Athens). 2021 Jun;20(2):395-403. doi: 10.1007/s42000-021-00274-6. Epub 2021 Feb 11.
PubMed 33575936Challis BG, Casey RT, Simpson HL, Gurnell M. Is there an optimal preoperative management strategy for phaeochromocytoma/paraganglioma? Clin Endocrinol (Oxf). 2017 Feb;86(2):163-167. doi: 10.1111/cen.13252. Epub 2016 Oct 24.
PubMed 27696513Randle RW, Balentine CJ, Pitt SC, Schneider DF, Sippel RS. Selective Versus Non-selective alpha-Blockade Prior to Laparoscopic Adrenalectomy for Pheochromocytoma. Ann Surg Oncol. 2017 Jan;24(1):244-250. doi: 10.1245/s10434-016-5514-7. Epub 2016 Aug 25.
PubMed 27561909Bihain F, Nomine-Criqui C, Guerci P, Gasman S, Klein M, Brunaud L. Management of Patients with Treatment of Pheochromocytoma: A Critical Appraisal. Cancers (Basel). 2022 Aug 9;14(16):3845. doi: 10.3390/cancers14163845.
PubMed 36010839
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Abandonment of Intravenous Volume Expansion After Preoperative Use of α-blockers in Patients With Adrenal Pheochromocytoma
- ClinicalTrials.gov ID
- NCT05803330
- Acronym / sponsor ID
- 202303-1
- Conditions
- Adrenal Pheochromocytoma, Hemodynamic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Kunwu Yan,MMUniversity, hospital or other
- Study start
- 20 Feb 2014 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 7 Apr 2023 (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.
Study of the relationship between hemodynamic stability and preoperative intravenous rehydration in patients with pheochromocytoma
Detailed description
All patients were subclassified into either the hemodynamic stability group (HS group) or the hemodynamic instability group (HU group) according to whether intraoperative hemodynamic instability occurred. Differences in data between the two groups were examined, and the risk factors for intraoperative hemodynamic instability were analyzed using logistic regression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PXB combined with venous dilation group | No intervention | –Use of PXB combined with intravenous volume expansion during preoperative preparation in patients with pheochromocytoma |
| PXB group | Experimental | Drug: Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytomaPXB alone during preoperative preparation in patients with pheochromocytoma |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of adrenal pheochromocytoma Must be able to swallow tablets
Key exclusion criteria (1 listed)
- Bilateral or multiple pheochromocytomas. Ectopic pheochromocytoma
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 |
|---|---|---|
| Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytomaAbandonment of intravenous volume expansion with alpha-blockers during preoperative preparation in patients with pheochromocytoma | Drug | PXB group |
Primary outcome
intraoperative mean arterial pressure
Time frame: During surgery
an intraoperative mean arterial pressure <60 mmHg is considered to be hemodynamically unstable
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 7 Apr 2023.
- Background: PubMed 33575936Meijs AC, Snel M, Corssmit EPM. Pheochromocytoma/paraganglioma crisis: case series from a tertiary referral center for pheochromocytomas and paragangliomas. Hormones (Athens). 2021 Jun;20(2):395-403. doi: 10.1007/s42000-021-00274-6. Epub 2021 Feb 11.
- Background: PubMed 27696513Challis BG, Casey RT, Simpson HL, Gurnell M. Is there an optimal preoperative management strategy for phaeochromocytoma/paraganglioma? Clin Endocrinol (Oxf). 2017 Feb;86(2):163-167. doi: 10.1111/cen.13252. Epub 2016 Oct 24.
- Background: PubMed 27561909Randle RW, Balentine CJ, Pitt SC, Schneider DF, Sippel RS. Selective Versus Non-selective alpha-Blockade Prior to Laparoscopic Adrenalectomy for Pheochromocytoma. Ann Surg Oncol. 2017 Jan;24(1):244-250. doi: 10.1245/s10434-016-5514-7. Epub 2016 Aug 25.
- Background: PubMed 36010839Bihain F, Nomine-Criqui C, Guerci P, Gasman S, Klein M, Brunaud L. Management of Patients with Treatment of Pheochromocytoma: A Critical Appraisal. Cancers (Basel). 2022 Aug 9;14(16):3845. doi: 10.3390/cancers14163845.
- Individual participant dataSharing planned: No
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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.
kunwu yan, Master principal investigator
Handan First Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytoma in people with Adrenal Pheochromocytoma and Hemodynamic, run by Kunwu Yan,MM.
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 1 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 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 mean arterial pressure (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05803330, which also lists 4 linked publications.
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 7 Apr 2023.