NCT04799509

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

4.9 years

First QC Date

March 12, 2021

Last Update Submit

March 17, 2021

Conditions

Keywords

non-small cell lung cancerVATS lobectomy90-day postoperative mortalityrisk scorevalidation

Outcome Measures

Primary Outcomes (1)

  • 90-day postoperative mortality

    Alive/Death (cause of death)

    90 day post surgical procedure

Interventions

VATS lobectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • \- Patients undergoing VATS lobectomy for non-small cell lung cancer

You may not qualify if:

  • Incomplete data for risk score calculation
  • Tumor size \>5 cm
  • Follow-up \<3 months
  • Patients undergoing neoadjuvant treatment
  • Patients undergoing extended resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 28577845BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Andrea Imperatori, MD

    Università degli Studi dell'Insubria

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator - Clinician at Center for Thoracic Surgery - School of Medicine and Surgery - University of Insubria - Varese

Study Record Dates

First Submitted

March 12, 2021

First Posted

March 16, 2021

Study Start

January 1, 2014

Primary Completion

November 27, 2018

Study Completion

November 27, 2018

Last Updated

March 22, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share