Pheochromocytoma and Hemodynamic Instability

NCT04566406 | Completed

• 1 other identifier: Pheochromocytoma&HI
• Study Type: observational
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aims of our study were to define perioperative HI during laparoscopic adrenalectomy for pheochromocytoma, assess the incidence of perioperative HI, and identify predictive factors of perioperative HI in our group of patients.

Conditions

Pheochromocytoma; Hypertension; Surgery

Keywords

pheochromocytoma; laparoscopy; haemodynamics; surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Hemodynamic Instability (n, %)

  Hemodynamic instability was defined as an occurrence of both intraoperative episodes of systolic blood pressure above 160 mm Hg and vasoactive (vasodilators or vasoconstrictors) drugs administration. Patients were divided into two groups: one which met both above criteria, and another one without hemodynamic instability.

  intraoperative

Secondary Outcomes (2)

• Number of Complications in Patients (n, %)

  Within 30 days after surgery

• Number of Cardiovascular Complications in Patients (n, %)

  Within 30 days after surgery

Other Outcomes (11)

• Length of hospital stay (days)

  Up to 30 days

• Duration of anaesthesia (min)

  Intraoperative

• Duration of surgery (min)

  Intraoperative

Interventions

Laparoscopic adrenalectomy PROCEDURE

Preoperative staging in all cases consisted of computed tomography or/and magnetic resonance imaging. Prior to surgery, a routine panel of laboratory tests was carried out. The catecholamines metabolites (metanephrine, normetanephrine, and methoxytyramine) were measured from 24-hour urine collection. All patients were preoperatively treated with phenoxybenzamine or alternative doxazosin.Additionally, beta-blockers in case of coexisting tachycardia were given. In the morning of the operation, preinduction blood pressure was measured. Pneumoperitoneum was achieved by insufflating CO2 gas to an intraperitoneal pressure of 12 mmHg. The operative method in our department was laparoscopic transperitoneal lateral total adrenalectomy. Intraoperatively SBP and diastolic blood pressure (DBP) were measured and recorded every 10 minutes. To treat hypertensive and hypotensive episodes, intravenous doses of urapidil, ephedrine, nitrates, MgSO4, norepinephrine, or ß-blockers were administered.

Eligibility Criteria

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

Study Population

Adult patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy

You may qualify if:

• patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy

You may not qualify if:

• bilateral tumour
• no histopathological result
• neoplastic spread

Sponsors & Collaborators

• Jagiellonian University: lead

MeSH Terms

Conditions

Pheochromocytoma; Hypertension

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 28, 2020
• Study Start: January 1, 2003
• Primary Completion: December 1, 2019
• Study Completion: September 1, 2020
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share