PheochromocytomaHEMODYNAMICSNCT07200245
Cardiovascular Complications After Adrenalectomy for Pheochromocytoma and Non-secreting Tumors
An observational study of Pheochromocytoma and Cardiovascular Complication, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pheochromocytoma, Cardiovascular Complication, Adrenal Incidentaloma
- What is being tested?
- adrenalectomy
- How many people
- 522 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2025to 31 Dec 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 ".
Who cannot join
- Children and minors (<18 years).
- Pregnant women.
- Patients with other indication for adrenalectomy in Eurocrine (i.e. Adrenocortical cancer, Cushing, Primary aldosteronism, Metastasis).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emeline CIROU contact
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Vandœuvre-lès-Nancy, Lorraine, 54511
About this study
Official title: Cardiovascular Complications After Adrenalectomy for Pheochromocytoma and Non-secreting Tumors - A Prospective Observational Multicenter European Study (HEMODYNAMICS)
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.
Read the detailed description
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.
- Being tested
- adrenalectomy
- Medical subject headings
- Pheochromocytoma, Adrenal incidentaloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adrenalectomyOther
adrenalectomy for pheochromocytoma and non-secreting tumor (incidentaloma)
| Study group | Role | What they receive |
|---|---|---|
| Pheochromocytoma | adrenalectomy for pheochromocytoma Receives: Other: adrenalectomy | |
| non-secreting tumor | adrenalectomy for non-secreting tumor (incidentaloma) Receives: Other: adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
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)
Measured: from induction of general anesthesia until discharge from the operating room
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).
Measured: from induction of general anesthesia until discharge from the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 522 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Eurocrine Council, European Society of Endocrine Surgery (ESES)
- Responsible party
- Principal investigator, Laurent BRUNAUD, Central Hospital, Nancy, France
- Investigators
- laurent BRUNAUD, MD, PhD, Principal investigator, University of Lorraine, CHRU Nancy,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200245
- Sponsor's protocol ID
- 8372 - Endocrine Tumour Base
- Acronym
- HEMODYNAMICS
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No