Study of Alpha-blockers Alone During Preoperative Preparation in Patients With Pheochromocytoma

NCT05803330 | Completed

• 1 other identifier: 202303-1
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study of the relationship between hemodynamic stability and preoperative intravenous rehydration in patients with pheochromocytoma

Conditions

Adrenal Pheochromocytoma; Hemodynamic

Outcome Measures

Primary Outcomes (1)

• intraoperative mean arterial pressure

  an intraoperative mean arterial pressure \<60 mmHg is considered to be hemodynamically unstable

  During surgery

Study Arms (2)

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

Drug: Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytoma

Interventions

Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytoma DRUG

Abandonment of intravenous volume expansion with alpha-blockers during preoperative preparation in patients with pheochromocytoma

PXB group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of adrenal pheochromocytoma Must be able to swallow tablets

You may not qualify if:

• Bilateral or multiple pheochromocytomas. Ectopic pheochromocytoma

Sponsors & Collaborators

• Kunwu Yan,MM: lead

Related Publications (4)

• 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.

  PMID: 33575936 BACKGROUND

• 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.

  PMID: 27696513 BACKGROUND

• 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.

  PMID: 27561909 BACKGROUND

• 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.

  PMID: 36010839 BACKGROUND

MeSH Terms

Conditions

Pheochromocytoma

Condition Hierarchy (Ancestors)

Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• kunwu yan, Master

  Handan First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Project Leader

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 7, 2023
• Study Start: February 20, 2014
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share