Cardiovascular Complications After Adrenalectomy for Pheochromocytoma and Non-secreting Tumors

NCT07200245 | Not Yet Recruiting

• 1 other identifier: 8372 - Endocrine Tumour Base
• Study Type: observational
• Target: 522
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pheochromocytoma is an adrenomedullary chromaffin cell tumour that releases catecholamines. Adverse cardiovascular events are considered the main cause of morbidity and mortality in patients with pheochromocytoma. Consequently, preoperative medical preparations using alpha-blockers or other antihypertensive drugs and the control of hemodynamic instability during adrenalectomy for pheochromocytoma are recommended by guidelines to prevent vasoconstriction, perioperative cardiovascular complications, and the risk of death. However, the definition of a catecholamine-induced hypertensive crisis in patients with pheochromocytoma has only recently been validated by an international consortium as the occurrence of systolic/diastolic blood pressure \>180/120 mmHg1. Limitations of published studies include small sample sizes, and single institution analysis. Some studies have reported substantial variability in the management of pheochromocytomas, with the use of routine preoperative medical preparation varying from 49% to 100%, whereas others have questioned the utility of this preparation for postoperative cardiovascular complications. The aim of this study was to evaluate pan-European practices in terms of specific preoperative medical preparation before surgery and to identify risk factors for postoperative cardiovascular complications 30 days after adrenalectomy for pheochromocytoma and non-secreting tumors (indication for surgery = " excluding malignancy "). The EUROCRINE® registry offers a valuable opportunity to assess clinical practices for preoperative medical preparation and the morbidity linked to adrenalectomy for pheochromocytoma and non-secreting tumors. This prospective study aims to refine surgical protocols and inform updates to existing guidelines, thereby advancing the management of adrenalectomy for pheochromocytoma.

Conditions

Pheochromocytoma; Cardiovascular Complication; Adrenal Incidentaloma

Outcome Measures

Primary Outcomes (1)

• cardiovascular complications at postoperative day 30

  cardiovascular complications at postoperative day 30 among the following cardiovascular events: myocardial infarction (MI), myocardial injury, cardiovascular death, non-fatal cardiac arrest (NFCA), coronary revascularization (CR), major adverse cardiac events (cardiac death or MI or CR or NFCA), pulmonary embolism, deep vein thrombosis, and atrial fibrillation.

  30 days

Secondary Outcomes (2)

• Intraoperative hypertensive episodes

  from induction of general anesthesia until discharge from the operating room

• Intraoperative hypotensive episodes

  from induction of general anesthesia until discharge from the operating room

Study Arms (2)

Pheochromocytoma

adrenalectomy for pheochromocytoma

Other: adrenalectomy

non-secreting tumor

adrenalectomy for non-secreting tumor (incidentaloma)

Other: adrenalectomy

Interventions

adrenalectomy OTHER

adrenalectomy for pheochromocytoma and non-secreting tumor (incidentaloma)

Pheochromocytoma; non-secreting tumor

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prospective, observational, multicenter, multinational study based on the EUROCRINE® registry. The study will use the my-EUROCRINE® module to add study-specific variables for patients included in the study protocol. Centers that transfer data to the EUROCRINE® registry will be invited to participate in this project. Patients with pheochromocytoma and non-secreting tumor (corresponding to patients with indication for surgery = " excluding malignancy ") will be included.

You may qualify if:

• Patients undergoing adrenalectomy for pheochromocytoma
• Patients undergoing adrenalectomy for non-secreting tumors. Patients with non-secreting tumors are those with indication for adrenalectomy in the Eurocrine database corresponding to " excluding malignancy ".

You may not qualify if:

• Children and minors (\<18 years).
• Pregnant women.
• Patients with other indication for adrenalectomy in Eurocrine (i.e. Adrenocortical cancer, Cushing, Primary aldosteronism, Metastasis).

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Eurocrine Council: collaborator
• European Society of Endocrine Surgery (ESES): collaborator

MeSH Terms

Conditions

Pheochromocytoma; Adrenal incidentaloma

Interventions

Adrenalectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• laurent BRUNAUD, MD, PhD

  University of Lorraine, CHRU Nancy,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

laurent BRUNAUD, MD, PhD

CONTACT

+33 0383153109; l.brunaud@chru-nancy.fr

Emeline CIROU

CONTACT

dporecherche@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor (PUPH)

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: October 1, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share