Cardiovascular Complications After Adrenalectomy for Pheochromocytoma and Non-secreting Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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 ".

Exclusion Criteria:

- Children and minors (<18 years).

- Pregnant women.

- Patients with other indication for adrenalectomy in Eurocrine (i.e. Adrenocortical cancer, Cushing, Primary aldosteronism, Metastasis).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07200245
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Central Hospital, Nancy, France
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	laurent BRUNAUD, MD, PhD
Principal Investigator Affiliation	University of Lorraine, CHRU Nancy,
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pheochromocytoma, Cardiovascular Complication, Adrenal Incidentaloma

Additional Details

The investigators propose a 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. Medical 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. All patients included will undergo a preoperative biological assessment (blood, urine, or not performed), an assessment of the dosage and duration of preoperative medical preparation using alpha-blockers (or not performed), an assessment of all intraoperative hypertensive and hypotensive crises (duration of all episodes defined according to validated criteria), and an assessment of cardiovascular complications at day 30 using a predefined definition of nine cardiovascular events. Consecutive patient enrolment is necessary to accurately reflect real clinical conditions. The standard variables are recorded as usual, with the addition of extra-variables (using My Eurocrine module) and detailed in the case report form (CRF). For defining intraoperative hypertensive episode(s), the investigators opted to utilize the established Nazari et al. definition published in 2023 (> 180 mmHg for systolic blood pressure and/or > 120 mmHg for diastolic blood pressure)1. For defining intraoperative hypotensive episode(s), the investigators used the Sessler and al. published definition in 2019 (mean arterial pressure < 65 mmHg)(POQI consensus)3. For these two intraoperative criteria, the total duration (in minutes from induction to discharge from the operating room) of the episodes will be collected at the end of the adrenalectomy in collaboration with the anesthesia team. For defining intraoperative cardiovascular complications and at 30 days after adrenalectomy, the investigators used the definition by Beattie et al.2, which corresponds to the presence of one or more of the nine clearly defined following 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.

Arms & Interventions

Arms

: Pheochromocytoma

adrenalectomy for pheochromocytoma

: non-secreting tumor

adrenalectomy for non-secreting tumor (incidentaloma)

Interventions

Other: - adrenalectomy

adrenalectomy for pheochromocytoma and non-secreting tumor (incidentaloma)

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

laurent BRUNAUD, MD, PhD

[email protected]

+33 0383153109

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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