Back to resultsStudy of Alpha-blockers Alone During Preoperative Preparation in Patients With Pheochromocytoma
Primary Purpose
Adrenal Pheochromocytoma, Hemodynamic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytoma
Sponsored by
About this trial
This is an interventional supportive care trial for Adrenal Pheochromocytoma
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of adrenal pheochromocytoma Must be able to swallow tablets Exclusion Criteria: Bilateral or multiple pheochromocytomas. Ectopic pheochromocytoma
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
PXB combined with venous dilation group
PXB group
Arm Description
Use of PXB combined with intravenous volume expansion during preoperative preparation in patients with pheochromocytoma
PXB alone during preoperative preparation in patients with pheochromocytoma
Outcomes
Primary Outcome Measures
intraoperative mean arterial pressure
an intraoperative mean arterial pressure <60 mmHg is considered to be hemodynamically unstable
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05803330
Brief Title
Study of Alpha-blockers Alone During Preoperative Preparation in Patients With Pheochromocytoma
Official Title
Clinical Study of Abandonment of Intravenous Volume Expansion After Preoperative Use of α-blockers in Patients With Adrenal Pheochromocytoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2014 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kunwu Yan,MM
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Pheochromocytoma, Hemodynamic
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PXB combined with venous dilation group
Arm Type
No Intervention
Arm Description
Use of PXB combined with intravenous volume expansion during preoperative preparation in patients with pheochromocytoma
Arm Title
PXB group
Arm Type
Experimental
Arm Description
PXB alone during preoperative preparation in patients with pheochromocytoma
Intervention Type
Drug
Intervention Name(s)
Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytoma
Intervention Description
Abandonment of intravenous volume expansion with alpha-blockers during preoperative preparation in patients with pheochromocytoma
Primary Outcome Measure Information:
Title
intraoperative mean arterial pressure
Description
an intraoperative mean arterial pressure <60 mmHg is considered to be hemodynamically unstable
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of adrenal pheochromocytoma Must be able to swallow tablets
Exclusion Criteria:
Bilateral or multiple pheochromocytomas. Ectopic pheochromocytoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kunwu yan, Master
Organizational Affiliation
Handan First Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33575936
Citation
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.
Results Reference
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PubMed Identifier
27696513
Citation
Challis 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.
Results Reference
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PubMed Identifier
27561909
Citation
Randle 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.
Results Reference
background
PubMed Identifier
36010839
Citation
Bihain 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.
Results Reference
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Study of Alpha-blockers Alone During Preoperative Preparation in Patients With Pheochromocytoma
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