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NCT Number: NCT04402749

The Incidence of Pulmonary Embolism During Nephrectomy

Patients with renal carcinoma was reported at high incidence of perioperative pulmonary embolism from current study. The investigators aimed to determine the incidence and outcome of this group of patient in the tertiary-care, university hospital and the rate of intraoperative transesophageal echocardiography utility and outcome.

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Key information

Conditions

Pulmonary Embolism Adenocarcinoma Carcinoma Carcinoma, Renal Cell Cardiovascular Diseases Embolism Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Lung Diseases Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nephrectomy Renal Cell Carcinoma Respiratory Tract Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

About this study

Perioperative pulmonary embolism (PE) is the serious adverse event leading to major morbidity and mortality. The incidence of PE during urologic surgery was previously report at 0.9 - 1.1% with mortality rate less than 2%. But the recent study by Fukazawa et al report the incidence of PE was 11% in renal cancer patients underwent nephrectomy with mortality rate as high as 33%. The risk factors associated with PE included major surgery, cancer, arrhythmia, massive bleeding and level of tumor thrombus in inferior vena cava.

Transesophageal echocardiography (TEE) is a very helpful intraoperative monitoring tool in major, non-cardiac surgery to detect emboli and guide the hemodynamic management in severely unstable patients. But it requires sophisticate machine and well-trained operator, the rate of utilisation was still limited.

The investigators aimed to determine the incidence of perioperative PE in renal cancer patients undergoing nephrectomy. the secondary outcomes include risk factors associated with perioperative PE, clinical outcomes, the rate of TEE utilization in this operation and outcome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients with renal cancer undergoing nephrectomy

Exclusion criteria

  • Patients with incomplete data

Treatment and study plan

Nephrectomy

Other

Patients underwent nephrectomy

Primary outcomes

  1. The incidence of intraoperative PE of renal cancer patient undergoing nephrectomy

    Time frame: intraoperative period

    Pulmonary embolism

    • Clinical suspicious:Systolic blood pressure < 90 mmHg without other reasonable causes, partial pressure of oxygen in artery < 80 mmHg
    • Confirmed diagnosis: intraoperative TEE (direct demonstration of PE or indirect signs of PE), CT angiography, perfusion lung scan

Secondary outcomes

  1. The incidence of postoperative PE of renal cancer patient undergoing nephrectomy

    Time frame: until 7 days after surgery

    Pulmonary embolism

    • Clinical suspicious:Systolic blood pressure < 90 mmHg without other reasonable causes, partial pressure of oxygen in artery < 80 mmHg
    • Confirmed diagnosis: intraoperative TEE (direct demonstration of PE or indirect signs of PE), CT angiography, perfusion lung scan

  2. Length of stay

    Time frame: 7 days after surgery

    • Hospital stay
    • ICU stay

  3. Number of patients with postoperative organ dysfunction

    Time frame: 7 days after surgery

    Organ dysfunction

    • acute kidney injury
    • acute respiratory distress syndrome

  4. Rate of TEE utilization

    Time frame: 7 days after surgery

    TEE utilization

    • for monitoring (use when the case begins)
    • for rescue (use when unexplained hypotension or hemodynamic collapsed)

  5. Mortality rate at 30 days postoperative

    Time frame: 30 days after surgery

    Patients death after surgery

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

The Incidence of Perioperative Pulmonary Embolism in Patients With Renal Carcinoma Undergoing Nephrectomy

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 27, 2020
Registry last updated
Mar 16, 2023

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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