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Completed

NCT Number: NCT04566406

Pheochromocytoma and Hemodynamic Instability

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The study was a retrospective observation of consecutive patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy between years 2003 and 2019.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy

Exclusion criteria

  • bilateral tumour
  • no histopathological result
  • neoplastic spread

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants with Hemodynamic Instability (n, %)

    Time frame: intraoperative

    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.

Secondary outcomes

  1. Number of Complications in Patients (n, %)

    Time frame: Within 30 days after surgery

    Data on morbidity were classified according to the Clavien-Dindo classification.

  2. Number of Cardiovascular Complications in Patients (n, %)

    Time frame: Within 30 days after surgery

    Cardiovascular morbidity was defined as postoperative morbidity related to the cardiovascular system: postoperative hypotensive or hypertensive episodes requiring pharmacologic treatment, need for blood transfusion, myocardial or digestive ischemia, stroke, and postoperative hospitalization in intensive care unit (ICU) for cardiac-related causes.

Other outcomes

  1. Length of hospital stay (days)

    Time frame: Up to 30 days

  2. Duration of anaesthesia (min)

    Time frame: Intraoperative

  3. Duration of surgery (min)

    Time frame: Intraoperative

  4. Patients needing blood transfusion, n (%)

    Time frame: Intraoperative

  5. Mean intraoperative blood loss (ml)

    Time frame: Intraoperative

  6. Number of participants who required intraoperative vasodilators administration (n, %)

    Time frame: Intraoperative

  7. Number of participants who required intraoperative vasopressors administration (n, %)

    Time frame: Intraoperative

  8. Patients with episodes systolic blood pressure >200 mmHg (n, %)

    Time frame: Intraoperative

  9. Patients with episodes systolic blood pressure >180 mmHg (n, %)

    Time frame: Intraoperative

  10. Patients with episodes systolic blood pressure >160 mmHg (n, %)

    Time frame: Intraoperative

  11. Number of participants who required postoperative vasopressorss administration (n, %)

    Time frame: Within 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Risk Factors for Hemodynamic Instability During Laparoscopic Pheochromocytoma Resection - Single Centre Experience

Important dates

Study start
2003
Primary completion
2019
Study completion
2020
First posted
Sep 28, 2020
Registry last updated
Sep 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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