Intraoperative Hemodynamic Instability During Unilateral Adrenalectomy for Pheochromocytoma

NCT06062082 | Completed

• 1 other identifier: reference 2020PI123
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Pheochromocytomas are tumors of the adrenal gland that develop from cells producing adrenaline and noradrenaline. Consequently, intraoperative blood pressure variations (hypertensive and hypotensive episodes) are characteristic of pheochromocytoma surgery, when these tumors are removed. However, recommendations for the management of these tumors are based on data essentially dating from the 1960s-1990s. Since then, anesthesia and surgery for patients with pheochromocytoma have evolved considerably, and have become more effective with time. In these circumstances, a review of the current situation is necessary. The aim of this study is to investigate the intraoperative hemodynamic changes observed in patients undergoing adrenalectomy for pheochromocytoma, comparing them with the hemodynamic profile observed in patients undergoing adrenal surgery for a pathology other than pheochromocytoma (control group).

Conditions

Pheochromocytoma; Non-Secretory Adrenal Adenoma

Keywords

adrenalectomy

Outcome Measures

Primary Outcomes (1)

• Hemodynamic instability score

  The haemodynamic instability score was calculated as a weighted continuous measure ranging from 0 to 160 points. This score appropriately quantifies deviations of blood pressure and heart rate from predefined thresholds, and infusion rates of vasoactive agents and fluids. Zero corresponds to the absence of peroperative hemodynamic changes and 160 to the maximum possible peroperative hemodynamic changes.

  during surgery (from induction of the patient under general anesthesia to discharge from the operating room)

Study Arms (2)

Pheochromocytoma

Patients operated on for pheochromocytoma by unilateral adrenalectomy

Procedure: adrenalectomy

Control

Patients operated on for adrenal tumor other than pheochromocytoma by unilateral adrenalectomy

Procedure: adrenalectomy

Interventions

adrenalectomy PROCEDURE

laparoscopic exeresis of the adrenal gland

Control; Pheochromocytoma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients operated on for unilateral adrenal pathology by laparosocopic approach (pheochromocytoma and non-pheochromocytoma) in the department of gastrointestinal, metabolic and cancer surgery (CVMC, CHU Nancy)

You may qualify if:

• Patients operated on for unilateral adrenal pathology by laparosocopic approach (pheochromocytoma and non-pheochromocytoma)

You may not qualify if:

• Patients operated on for unilateral adrenal pathology by laparosocopic approach (pheochromocytoma and non-pheochromocytoma)
• Patients operated on for bilateral adrenal pathology

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)

Nancy, 54511, France

Location

Related Publications (2)

• Buitenwerf E, Boekel MF, van der Velde MI, Voogd MF, Kerstens MN, Wietasch GJKG, Scheeren TWL. The haemodynamic instability score: Development and internal validation of a new rating method of intra-operative haemodynamic instability. Eur J Anaesthesiol. 2019 Apr;36(4):290-296. doi: 10.1097/EJA.0000000000000941.

  PMID: 30624247 RESULT

• Buitenwerf E, Osinga TE, Timmers HJLM, Lenders JWM, Feelders RA, Eekhoff EMW, Haak HR, Corssmit EPM, Bisschop PHLT, Valk GD, Veldman RG, Dullaart RPF, Links TP, Voogd MF, Wietasch GJKG, Kerstens MN. Efficacy of alpha-Blockers on Hemodynamic Control during Pheochromocytoma Resection: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2020 Jul 1;105(7):2381-91. doi: 10.1210/clinem/dgz188.

  PMID: 31714582 RESULT

MeSH Terms

Conditions

Pheochromocytoma

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

  CHU Nancy, Department CVMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: October 2, 2023
• Study Start: September 1, 2015
• Primary Completion: August 31, 2019
• Study Completion: September 1, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

FR (1)