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NCT04799509 Clinical Trial

Assessment of the 90-day Mortality Risk Score After VATS Lobectomy

Lung Cancer Clinical Trial

Official title:
Assessment of the 90-day Mortality Risk Score After Video-assisted Thoracoscopic Lobectomy in the Italian VATS Group Cohort

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04799509
Other study ID # VALIDATION
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date November 27, 2018

Study information
Verified date March 2021
Source Università degli Studi dell'Insubria
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A five classes (A-E) aggregate risk score predicting 90-day mortality after video-assisted thoracoscopic lobectomy for lung cancer, including as independent factors male sex (3 points), carbon monoxide lung diffusion capacity <60% (1 point) and operative time >150 minutes (1 point), has been recently published. This study aims to assess the effectiveness and reliability of this risk model in a large, independent cohort of patients, in order to confirm its generalizability.

Description:

From the Italian VATS Group Database, we selected patients who underwent video-assisted thoracoscopic lobectomy for non-small cell lung cancer. We calculated the aggregate risk score and the corresponding class of 90-day mortality risk for each patient. The correlation between risk classes and mortality rates was tested by Spearman's rho-test. Model calibration was evaluated by Hosmer-Lemeshow goodness-of-fit test.

Recruitment information / eligibility
Status Completed
Enrollment 2209
Est. completion date November 27, 2018
Est. primary completion date November 27, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients undergoing VATS lobectomy for non-small cell lung cancer Exclusion Criteria: - Incomplete data for risk score calculation - Tumor size >5 cm - Follow-up <3 months - Patients undergoing neoadjuvant treatment - Patients undergoing extended resection

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• VATS lobectomy
VATS lobectomy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Università degli Studi dell'Insubria

References & Publications (1)

Brunelli A, Dinesh P, Woodcock-Shaw J, Littlechild D, Pompili C. Ninety-Day Mortality After Video-Assisted Thoracoscopic Lobectomy: Incidence and Risk Factors. Ann Thorac Surg. 2017 Sep;104(3):1020-1026. doi: 10.1016/j.athoracsur.2017.02.083. Epub 2017 Jun 1. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 90-day postoperative mortality Alive/Death (cause of death) 90 day post surgical procedure
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