3D Lung Reconstructions Using Open-source Software for Lung Cancer Surgery (3D-LUNG)

November 9, 2023 updated by: Zuyderland Medisch Centrum

Evaluating Three-dimensional Lung Reconstructions for Uniportal Thoracoscopic Lung Resections Using Open-source Software

Preoperative three-dimensional (3D) lung reconstructions can reduce intraoperative blood loss, conversion rate, and operation duration. Commercial products predominantly provide these 3D reconstructions, hence the aim of this study was to assess the usability and performance of preoperative 3D lung reconstructions created with open-source software.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A single-center prospective pilot study is conducted within the thoracic surgery department of the Zuyderland Medical Center, Heerlen, the Netherlands. Patients are recruited during preoperative consultation with the thoracic surgeon. The aim of this study is to include at least 12 patients in this pilot study based on the sample size for pilot studies.

Before the pilot study, the surgeons involved in the study set several requirements for the 3D lung reconstructions. A technical physician, a healthcare professional in the Netherlands who combines knowledge of technology and medicine and is licensed to perform medical interventions, creates three-dimensional lung reconstructions using open-source 3D Slicer software that fulfills these aforementioned requirements and uses the available preoperative diagnostic late arterial phase contrast-enhanced CT scans.

Three thoracic surgeons (with at least five years of uniportal VATS experience) and one surgical resident in thoracic surgery assess these 3D lung reconstructions for preoperative planning of uniportal VATS anatomical resections and compare the outcome measures based on the 3D lung reconstructions with the 2D CT scan and intraoperative findings.

Patient characteristics, including age, sex, Eastern Cooperative Oncology Group (ECOG) performance status, body mass index, American Society of Anesthesiologists classification, forced expiratory volume in 1s (FEV1), diffusion capacity of the lung for carbon monoxide by the single-breath technique (DLCO-SB), intoxications, clinical Tumor Nodule Metastasis (TNM) classification 8th edition, previous thoracic surgery, and comorbidities are extracted from patient records. The following perioperative and postoperative data are collected: surgical approach, planned lung resection, performed lung resection, surgery duration, conversion, blood loss, surgery difficulty, the radicality of resection, pathological TNM classification 8th edition, tumor size, final pathology, drain duration, length of hospital stay, and complications within 30 days of surgery. The difficulty of the surgical procedure will be assessed by the thoracic surgeon and rated on a 5-point Likert scale from 1 (very easy) to 5 (very difficult). Length of hospital stay is defined as the number of days between the first day after surgery and the day the patient was clinically discharged.

Descriptive statistical analyses are performed in IBM SPSS Statistics v28 (MacOS, Armonk, New York, United States). Missing data will be reported as such.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands, 6419PC
        • Zuyderland Medical Center

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

Description

Inclusion Criteria:

Patients with suspected or biopsy-proven lung cancer scheduled for video-assisted thoracoscopy surgery for lobectomy or segmentectomy

Exclusion Criteria:

  • Computed Tomography scan contained motion artifacts
  • Surgery was canceled
  • Planned surgery changed intraoperatively to another procedure
  • Patients who did not provide informed consent

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

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative 3D lung reconstruction
Patients who were planned for an anatomical lung resection with preoperative 3D lung reconstruction.
Device: Preoperative 3D lung reconstruction created with open-source software
Preoperative 3D lung reconstruction created with open-source software 3D Slicer
Other Names:
  • 3D Slicer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Score
Time Frame: Single-point evaluation after surgery (at day 0)
System Usability Score Questionnaire. This questionnaire includes 10 statements rated from 1 (strongly disagree) to 5 (strongly agree). The even-numbered questions contributed to the scale position 5 minus the scale position, while the odd-numbered questions contributed to the scale position minus 1. The final score was calculated by the sum of the even and uneven-numbered questions, multiplied by 2.5. The minimum system usability score is 0 and the maximum is 100. A system usability score above 68 is considered above average.
Single-point evaluation after surgery (at day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Segmental lung nodule location
Time Frame: Baseline and during surgery (at day 0)
The performance of the 3D lung reconstructions is evaluated based on the anatomical validity of the 3D lung reconstructions compared to the two-dimensional (2D) CT scan and intraoperative findings. Before surgery, a number of anatomical components of the 3D lung reconstructions are assessed. During surgery, the anatomical validity of these anatomical components is verified. One of the anatomical components includes the segmental location of the lung nodule.
Baseline and during surgery (at day 0)
Number of arteries to target lobe or segment
Time Frame: Baseline and during surgery (at day 0)
The performance of the 3D lung reconstructions is evaluated based on the anatomical validity of the 3D lung reconstructions compared to the two-dimensional (2D) CT scan and intraoperative findings. Before surgery, a number of anatomical components of the 3D lung reconstructions are assessed. During surgery, the anatomical validity of these anatomical components is verified. One of the anatomical components includes the number of arteries towards the target lobe or segment.
Baseline and during surgery (at day 0)
Anatomical variations
Time Frame: Baseline and during surgery (at day 0)
The performance of the 3D lung reconstructions is evaluated based on the anatomical validity of the 3D lung reconstructions compared to the two-dimensional (2D) CT scan and intraoperative findings. Before surgery, a number of anatomical components of the 3D lung reconstructions are assessed. During surgery, the anatomical validity of these anatomical components is verified. One of the anatomical components includes the presence of (a) anatomical variation(s).
Baseline and during surgery (at day 0)
Potential change of surgery or surgical plan
Time Frame: Single-point evaluation after surgery (at day 0)
As another part of the evaluation of the performance, the potential impact of the 3D lung reconstructions on the surgical plan was also considered. Therefore, the surgeon was asked after surgery if the 3D lung reconstruction would have resulted in a preoperative change in surgical approach.
Single-point evaluation after surgery (at day 0)
Intraoperative use of 3D lung reconstruction
Time Frame: Single-point evaluation after surgery (at day 0)
As final part of the evaluation of the performance, the potential value during surgery of the 3D lung reconstructions was also considered. Therefore, the surgeon was asked after surgery whether they would like to have used the 3D lung reconstruction during surgery via a tablet for example.
Single-point evaluation after surgery (at day 0)

Collaborators and Investigators

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

Sponsor

Zuyderland Medisch Centrum

Investigators

  • Principal Investigator: Erik de Loos, PhD, Department of Surgery, Zuyderland Medical Center, Heerlen, the Netherlands

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

  • Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 2005;4:287-91.
  • Lewis JR, Sauro J. Item benchmarks for the system usability scale. J Usability Stud 2018;13.
  • Brooke J. SUS: a 'quick and dirty' usability. Usability Eval Ind 1996;189:189-94.

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)

December 21, 2022

Primary Completion (Actual)

March 13, 2023

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z2022177
  • METCZ20220105 (Other Identifier: METC Z)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data that support the findings of this study are available from the corresponding author, ER de Loos, upon reasonable request.

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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