Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000913471
Ethics application status
Approved
Date submitted
7/08/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Date data sharing statement initially provided
22/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outcome after surgery for lung cancer
Scientific title
Textbook outcome after pulmonary resection for non-small cell lung cancer
Secondary ID [1] 315089 0
None
Universal Trial Number (UTN)
U1111-1326-6415
Trial acronym
Linked study record
This study is a secondary analysis of data collected under the ethically approved project titled: The financial burden of complications associated with surgical lung resection: a retrospective audit.sub-study of (ACTRN12625000112460).

Health condition
Health condition(s) or problem(s) studied:
Surgical removal/resection of the lung 338485 0
Complications following lung resection surgery 338486 0
Non small cell lung cancer 338487 0
Condition category
Condition code
Surgery 334790 334790 0 0
Other surgery
Anaesthesiology 334791 334791 0 0
Other anaesthesiology
Cancer 334792 334792 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is a secondary analysis of data collected under the ethically approved project titled: The financial burden of complications associated with surgical lung resection: a retrospective audit.

In this study we will be observing the number of patients that have had a textbook outcome after lung resection surgery for non-small cell lung cancer (NSCLC) between 1 January 2011 and 31st December 2023.

The concept of a composite metric known as the textbook outcome has emerged as a patient-centred quality measure, Textbook outcome integrates multiple clinical and perioperative outcomes into a single, readily interpretable indicator capturing the ideal postoperative scenario.

Our definition of a textbook outcome for NSCLC resection are the following:
1. Negative resection margins, confirmed through microscopy
2. Complete lymph node dissection (LND), defined with expert input from thoracic surgeons, and in accordance with guidelines published by the International Association for the Study of Lung Cancer. This includes a minimum of six lymph node stations assessed: at least three from the mediastinum, including the subcarinal node (station 7), and three from the hilar and intrapulmonary stations or laterality-specific inclusion of stations, which are 2R, 4R, 7, 10R, and 11R for right-sided tumours, and 5, 6, 7, 10 L, and 11 L for left-sided tumours
3. No mortality within 30 days of the index operation
4. No reintervention within 30 days of the index operation (video-assisted thoracoscopic surgery, thoracotomy, bronchoscopy, or percutaneous drainage)
5. No prolonged stay or readmission to the ICU or HDU after discharge to general wards
6. No prolonged hospital stay (greater or equal to 14 days)
7. No hospital readmission after hospital discharge
8. No major complications during the index stay, excluding those accounted for by screening for reinterventions within 30 days, with major complications defined as Clavien-Dindo class III or greater15:
a. III: complications requiring surgical, endoscopic, or radiological intervention
b. III-a: class III interventions without general anaesthesia
c. III-b: class III interventions under general anaesthesia
d. IV: life-threatening complications requiring admission to the ICU
e. IV-a: single-organ dysfunction, including dialysis
f. IV-b: multiorgan dysfunction
g. V: death

As this is a retrospective study, there is no participant involvement. Only the de-identified hospital medical record of NSCLC adult patients who have undergone lung resection will be reviewed.
Intervention code [1] 331702 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator group are those patients who do not have a textbook outcome.
Control group
Active

Outcomes
Primary outcome [1] 342429 0
The primary outcome is the number of patients with a textbook outcome after lung resection surgery. All measures that define a textbook outcome will be assessed as a composite primary outcome.
Timepoint [1] 342429 0
Textbook outcome will be calculated from completion of surgery to 30 days after hospital discharge.
Secondary outcome [1] 450784 0
Patient mortality after any type of lung resection.
Timepoint [1] 450784 0
This will result in an observation follow up period of at least months post index surgery.

Eligibility
Key inclusion criteria
Inclusion criteria will include:

1. Any type of lung resection
2. Adult patient with non-small cell lung cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude patients undergoing the following procedure

1. Pleurodesis
2. Pulmonary decortication including mesothelioma surgery
3. Other procedures on the pleura
4. Tracheal and bronchial (parenchyma sparing resection)
5. Oesophagectomy
6. Mediastinal tumour resections/mediastinoscopy
7. Endobronchial procedures on bronchus and trachea
8. Chest wall surgery of rib/s

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Analyses were performed in R (version 4.5.0) with relevant packages for data manipulation, regression modelling, and survival analyses. Outliers and missing data were identified with interquartile range (IQR) criteria, defined as values outside the range of 1.5 times the IQR below the 1st quartile or above the 3rd quartile. After verification against the original data source, we removed patients with missing values in variables with less than 5% missingness on a case-wise basis or used multiple imputation otherwise. Patients were subsequently grouped by TO status.

Baseline characteristics, perioperative components, and oncological characteristics were summarised with descriptive statistics. Categorical variables were compared with chi-square or Fisher’s exact tests, and are reported as counts and percentages. Continuous variables were compared with the Wilcoxon rank-sum test, and are reported as medians and IQRs, or means and standard deviations (SDs). A two-sided p-value < 0.05 was considered statistically significant. Effect sizes were calculated with rank-biserial correlation for continuous variables and Cramér’s V for categorical variables.

To identify independent predictors of TO, we selected variables according to clinical relevance and univariable statistical significance. Multicollinearity was assessed with the variance inflation factor across all imputed datasets, by ensuring that no variables exceeded a variance inflation factor threshold of 2. The final variable selection ensured acceptable collinearity and preserved a minimum of ten events per degree of freedom. Multivariable logistic regression was then performed with the ENTER method across all imputations, and results were pooled with Rubin’s rules.19

Kaplan-Meier survival curves and log-rank tests were used to compare long-term survival according to TO status, and additional subgroup analyses were stratified by lobar versus sublobar resection. Propensity score matching (PSM) was performed with the optimal matching algorithm, on the basis of a logistic regression–derived propensity score, implemented via the MatchIt and optmatch packages.20,21 Covariates in the propensity model for TO included age, sex, CCI, smoking status, lung function test results, surgical approach, operation type (lobar, sublobar, or pneumonectomy), and clinical stage (I–III). Beyond the exclusion of resection type during PSM for the subgroup analysis, the covariates in the two PSM models were identical. Covariate balance was assessed with standardised mean differences (SMDs), with values < 0.1 indicating good balance for a given covariate, and visualised with Love plots. Kaplan-Meier survival curves and log-rank tests were implemented for the propensity score matched cohorts.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/02/2025
Date of last participant enrolment
Anticipated
Actual
31/03/2025
Date of last data collection
Anticipated
Actual
14/04/2025
Sample size
Target
731
Accrual to date
Final
731
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28305 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 44517 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 319661 0
Hospital
Name [1] 319661 0
Austin Health - Department of Anaesthesia
Country [1] 319661 0
Australia
Primary sponsor type
Hospital
Name
Austin Health - Department of Anaesthesia
Address
Country
Australia
Secondary sponsor category [1] 322164 0
None
Name [1] 322164 0
Address [1] 322164 0
Country [1] 322164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318225 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 318225 0
Ethics committee country [1] 318225 0
Australia
Date submitted for ethics approval [1] 318225 0
27/01/2025
Approval date [1] 318225 0
24/02/2025
Ethics approval number [1] 318225 0
Approval number: VicTRI-20827

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143490 0
Prof Laurence Weinberg
Address 143490 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 143490 0
Australia
Phone 143490 0
+61 3 94965249
Fax 143490 0
Email 143490 0
[email protected]
Contact person for public queries
Name 143491 0
Laurence Weinberg
Address 143491 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 143491 0
Australia
Phone 143491 0
+61 3 94965249
Fax 143491 0
Email 143491 0
[email protected]
Contact person for scientific queries
Name 143492 0
Laurence Weinberg
Address 143492 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 143492 0
Australia
Phone 143492 0
+61 3 94965249
Fax 143492 0
Email 143492 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Participants have not provided consent for their data to be shared.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.