NCT07436598

Brief Summary

This study aims to validate a novel preoperative assessment strategy using three-dimensional (3-D) computed tomography (CT) reconstruction and virtual resection simulation. The goal is to accurately predict postoperative pulmonary function in patients with non-small cell lung cancer (NSCLC) undergoing Video-Assisted Thoracoscopic Surgery (VATS) anatomical resection. Accurate prediction of postoperative lung function is crucial for patient safety. Traditional methods, such as segment counting, often lack precision because they assume all lung segments contribute equally to function, ignoring variations caused by tumors or emphysema. This study utilizes 3-D "virtual resection" to quantify the "Planned Resected Ventilated Lung Volume Fraction" (pRVLVF) before surgery. The study will recruit 60 participants divided into two groups: those undergoing lobectomy (n=30) and those undergoing segmentectomy (n=30). Participants will undergo standard thin-slice CT scans and pulmonary function tests (PFT) before surgery. Postoperatively, lung function and recovery will be tracked at 3, 6, and 12 months to develop a dynamic prediction model and evaluate the compensatory capacity of the residual lung.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress15%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

February 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 7, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

May 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

February 22, 2026

Last Update Submit

May 10, 2026

Conditions

Keywords

Three-dimensional virtual resectionPulmonary Function PredictionVentilated Lung Volume Fraction (VLVF)VATS Anatomical ResectionSegmentectomyLobectomyPostoperative Compensation Coefficient

Outcome Measures

Primary Outcomes (1)

  • Mean Absolute Error (MAE) of Predicted Postoperative FEV1

    The accuracy of the preoperative 3D virtual resection model will be evaluated by calculating the Mean Absolute Error (MAE) between the predicted FEV1 and the actual measured FEV1. A lower MAE indicates higher prediction accuracy. The study targets an MAE of less than 180 mL.

    3 months post-operation

Secondary Outcomes (1)

  • Long-term Prediction Error of FEV1 and FVC

    6 months and 12 months post-operation

Study Arms (2)

VATS Segmentectomy Group

Patients with non-small cell lung cancer scheduled to undergo video-assisted thoracoscopic segmentectomy.

VATS Lobectomy Group

Patients with non-small cell lung cancer scheduled to undergo video-assisted thoracoscopic lobectomy.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with non-small cell lung cancer recruited from the thoracic surgery outpatient clinics and inpatient wards of National Taiwan University Hospital.

You may qualify if:

  • Patients scheduled for video-assisted thoracoscopic (VATS) lobectomy or segmentectomy at National Taiwan University Hospital or NTU Cancer Center.
  • Age between 18 and 80 years.
  • Patients who have signed the informed consent form agreeing to provide imaging data for 3D modeling.

You may not qualify if:

  • Age younger than 18 or older than 80 years.
  • Patients not scheduled for VATS lobectomy or segmentectomy.
  • Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
  • Patients unable or unwilling to sign the informed consent form.
  • Vulnerable populations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Cancer Center

Taipei, Taiwan

RECRUITING

Related Publications (12)

  • Chen L, Yang J, Zhang C, Zhang L, Han X, Dong C, Gui S, Liu X, Shi H. Quantitative computed tomography assessment of pulmonary function and compensation after lobectomy and segmentectomy in lung cancer patients. J Thorac Dis. 2024 Sep 30;16(9):5765-5778. doi: 10.21037/jtd-24-492. Epub 2024 Sep 6.

    PMID: 39444877BACKGROUND
  • Colombi D, Risoli C, Delfanti R, Chiesa S, Morelli N, Petrini M, Capelli P, Franco C, Michieletti E. Software-Based Assessment of Well-Aerated Lung at CT for Quantification of Predicted Pulmonary Function in Resected NSCLC. Life (Basel). 2023 Jan 10;13(1):198. doi: 10.3390/life13010198.

    PMID: 36676147BACKGROUND
  • Jeong YH, Lee H, Jang HJ, Park DW, Choi YY, Lee SJ. Predicting postoperative lung function using ventilation SPECT/CT in patients with lung cancer. J Thorac Dis. 2024 Feb 29;16(2):1054-1062. doi: 10.21037/jtd-23-1563. Epub 2024 Feb 26.

    PMID: 38505088BACKGROUND
  • Kang HJ, Lee SS. Comparison of Predicted Postoperative Lung Function in Pneumonectomy Using Computed Tomography and Lung Perfusion Scans. J Chest Surg. 2021 Dec 5;54(6):487-493. doi: 10.5090/jcs.21.084.

    PMID: 34815369BACKGROUND
  • Bolliger CT, Guckel C, Engel H, Stohr S, Wyser CP, Schoetzau A, Habicht J, Soler M, Tamm M, Perruchoud AP. Prediction of functional reserves after lung resection: comparison between quantitative computed tomography, scintigraphy, and anatomy. Respiration. 2002;69(6):482-9. doi: 10.1159/000066474.

    PMID: 12456999BACKGROUND
  • Wu MT, Chang JM, Chiang AA, Lu JY, Hsu HK, Hsu WH, Yang CF. Use of quantitative CT to predict postoperative lung function in patients with lung cancer. Radiology. 1994 Apr;191(1):257-62. doi: 10.1148/radiology.191.1.8134584.

    PMID: 8134584BACKGROUND
  • Wu MT, Pan HB, Chiang AA, Hsu HK, Chang HC, Peng NJ, Lai PH, Liang HL, Yang CF. Prediction of postoperative lung function in patients with lung cancer: comparison of quantitative CT with perfusion scintigraphy. AJR Am J Roentgenol. 2002 Mar;178(3):667-72. doi: 10.2214/ajr.178.3.1780667.

    PMID: 11856695BACKGROUND
  • Ueda K, Tanaka T, Hayashi M, Li TS, Tanaka N, Hamano K. Computed tomography-defined functional lung volume after segmentectomy versus lobectomy. Eur J Cardiothorac Surg. 2010 Jun;37(6):1433-7. doi: 10.1016/j.ejcts.2010.01.002. Epub 2010 Feb 11.

    PMID: 20153214BACKGROUND
  • Ueda K, Tanaka T, Li TS, Tanaka N, Hamano K. Quantitative computed tomography for the prediction of pulmonary function after lung cancer surgery: a simple method using simulation software. Eur J Cardiothorac Surg. 2009 Mar;35(3):414-8. doi: 10.1016/j.ejcts.2008.04.015. Epub 2008 May 16.

    PMID: 18485724BACKGROUND
  • Fernandez-Rodriguez L, Torres I, Romera D, Galera R, Casitas R, Martinez-Ceron E, Diaz-Agero P, Utrilla C, Garcia-Rio F. Prediction of postoperative lung function after major lung resection for lung cancer using volumetric computed tomography. J Thorac Cardiovasc Surg. 2018 Dec;156(6):2297-2308.e5. doi: 10.1016/j.jtcvs.2018.07.040. Epub 2018 Aug 2.

    PMID: 30195604BACKGROUND
  • Oswald NK, Halle-Smith J, Mehdi R, Nightingale P, Naidu B, Turner AM. Predicting Postoperative Lung Function Following Lung Cancer Resection: A Systematic Review and Meta-analysis. EClinicalMedicine. 2019 Sep 10;15:7-13. doi: 10.1016/j.eclinm.2019.08.015. eCollection 2019 Oct.

    PMID: 31709409BACKGROUND
  • Park H, Yun J, Lee SM, Hwang HJ, Seo JB, Jung YJ, Hwang J, Lee SH, Lee SW, Kim N. Deep Learning-based Approach to Predict Pulmonary Function at Chest CT. Radiology. 2023 Apr;307(2):e221488. doi: 10.1148/radiol.221488. Epub 2023 Feb 14.

    PMID: 36786699BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Chih-Hsiang Chang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Surgery

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

April 7, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

May 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations