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

March 17, 2021 updated by: Maria Cattoni, Università degli Studi dell'Insubria

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

2209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients were selected from the Italian VATS Group registry (a database containing prospectively collected data on VATS anatomical lung resection performed in 58 certified thoracic surgery centers from January 1st 2014). The VATS Group database was awarded by the European Society of Thoracic Surgeons in the 2017

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90-day postoperative mortality
Time Frame: 90 day post surgical procedure
Alive/Death (cause of death)
90 day post surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi dell'Insubria

Investigators

  • Study Director: Andrea Imperatori, MD, Università degli Studi dell'Insubria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

November 27, 2018

Study Completion (Actual)

November 27, 2018

Study Registration Dates

First Submitted

March 12, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VALIDATION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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