The Incidence of Pulmonary Embolism During Nephrectomy

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402749
• Other study ID #: 2020_2
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: December 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with renal cancer undergoing nephrectomy

Exclusion Criteria:

• Patients with incomplete data

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Embolism
• Nephrectomy
• Pulmonary Embolism
• Renal Cell Carcinoma

Intervention

Other:
• Nephrectomy
Patients underwent nephrectomy

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

Cisek LJ, Walsh PC. Thromboembolic complications following radical retropubic prostatectomy. Influence of external sequential pneumatic compression devices. Urology. 1993 Oct;42(4):406-8. doi: 10.1016/0090-4295(93)90369-l. — View Citation

Desciak MC, Martin DE. Perioperative pulmonary embolism: diagnosis and anesthetic management. J Clin Anesth. 2011 Mar;23(2):153-65. doi: 10.1016/j.jclinane.2010.06.011. — View Citation

Fukazawa K, Fong CT, Gologorsky E. Inferior Vena Cava Tumor Thrombus Dynamics and Perioperative Pulmonary Embolism: A Single-Center Experience. J Cardiothorac Vasc Anesth. 2019 Oct;33(10):2728-2734. doi: 10.1053/j.jvca.2019.03.011. Epub 2019 Mar 15. — View Citation

Pettus JA, Eggener SE, Shabsigh A, Yanke B, Snyder ME, Serio A, Vickers A, Russo P, Donat SM. Perioperative clinical thromboembolic events after radical or partial nephrectomy. Urology. 2006 Nov;68(5):988-92. doi: 10.1016/j.urology.2006.06.026. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of intraoperative PE of renal cancer patient undergoing nephrectomy	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	intraoperative period
Secondary	The incidence of postoperative PE of renal cancer patient undergoing nephrectomy	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	until 7 days after surgery
Secondary	Length of stay	Hospital stay; ICU stay	7 days after surgery
Secondary	Number of patients with postoperative organ dysfunction	Organ dysfunction; acute kidney injury; acute respiratory distress syndrome	7 days after surgery
Secondary	Rate of TEE utilization	TEE utilization; for monitoring (use when the case begins); for rescue (use when unexplained hypotension or hemodynamic collapsed)	7 days after surgery
Secondary	Mortality rate at 30 days postoperative	Patients death after surgery	30 days after surgery