Cardiovascular Complications After Adrenalectomy for Pheochromocytoma and Non-secreting Tumors
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorCentral Hospital, Nancy, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 ".
Disqualifiers
Children and minors (<18 years).
Pregnant women.
Patients with other indication for adrenalectomy in Eurocrine (i.e. Adrenocortical cancer, Cushing, Primary aldosteronism, Metastasis).
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
adrenalectomy
Other interventionadrenalectomy for pheochromocytoma and non-secreting tumor (incidentaloma)
Treatment groups
522 Participants
are divided into 2 treatment groupsGroup A: Pheochromocytoma1 intervention
Group B: non-secreting tumor1 intervention
Trial outcomes
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.
Time frame
30 daysSecondary outcomes
1
Intraoperative hypertensive episodes
duration of all intraoperative blood pressure episode(s) \> 180 mmHg systolic and/or \> 120 mmHg diastolic between induction and discharge from the operating room (duration in minutes)
Time frame
from induction of general anesthesia until discharge from the operating room2
Intraoperative hypotensive episodes
duration of all intraoperative mean arterial pressure episode(s) below 65 mmHg between induction and discharge from the operating room (duration in minutes).
Time frame
from induction of general anesthesia until discharge from the operating roomLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Central Hospital, Nancy, France
Lead sponsor
Eurocrine Council
Collaborator
European Society of Endocrine Surgery (ESES)
Collaborator
Source ClinicalTrials.gov
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