Lung Cancer3D-LUNGNCT06132607
3D Lung Reconstructions Using Open-source Software for Lung Cancer Surgery
An observational study of Lung Cancer and Thoracic Surgery, Video-Assisted, run by Erik de Loos at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Thoracic Surgery, Video-Assisted, Lobectomy
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Dec 2022to 4 Apr 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred for a segmentectomy or lobectomy
Who may be able to join
- Patients with suspected or biopsy-proven lung cancer scheduled for video-assisted thoracoscopy surgery for lobectomy or segmentectomy
Who cannot join
- Computed Tomography scan contained motion artifacts
- Surgery was canceled
- Planned surgery changed intraoperatively to another procedure
- Patients who did not provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer, Thoracic Surgery, Video-Assisted, Lobectomy, Segmentectomy, Humans, Surgery
- Keywords
- video-assisted thoracoscopic surgery, lung cancer, three-dimensional reconstruction, three-dimensional simulation, open-source software
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative 3D lung reconstruction | Patients who were planned for an anatomical lung resection with preoperative 3D lung reconstruction from CT images |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Score
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.
Measured: Single-point evaluation after surgery (at day 0)
Secondary outcomes (5)
Segmental lung nodule location
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.
Measured: Baseline and during surgery (at day 0)
Number of arteries to target lobe or segment
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.
Measured: Baseline and during surgery (at day 0)
Anatomical variations
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).
Measured: Baseline and during surgery (at day 0)
Potential change of surgery or surgical plan
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.
Measured: Single-point evaluation after surgery (at day 0)
Intraoperative use of 3D lung reconstruction
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.
Measured: Single-point evaluation after surgery (at day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start21 Dec 2022
- Primary completion13 Mar 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Erik de Loos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erik de Loos, Zuyderland Medisch Centrum
- Investigators
- Erik de Loos, PhD, Principal investigator, Department of Surgery, Zuyderland Medical Center, Heerlen, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132607
- Sponsor's protocol ID
- Z2022177
- Other IDs
- METCZ20220105
- Acronym
- 3D-LUNG
- Status last verified
- Mar 2026
- First submitted
- 31 Oct 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author, ER de Loos, upon reasonable request.
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.
Laven IEWG, Oosterhoff VPS, Franssen AJPM, van Roozendaal LM, Hulsewe KWE, Vissers YLJ, de Loos ER. Evaluating three-dimensional lung reconstructions for thoracoscopic lung resections using open-source software: a pilot study. Transl Lung Cancer Res. 2024 Jul 30;13(7):1595-1608. doi: 10.21037/tlcr-24-134. Epub 2024 Jul 16.
PubMed 39118878
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Three-dimensional Lung Reconstructions for Uniportal Thoracoscopic Lung Resections Using Open-source Software
- ClinicalTrials.gov ID
- NCT06132607
- Acronym / sponsor ID
- 3D-LUNG / Z2022177
- Conditions
- Lung Cancer, Thoracic Surgery, Video-Assisted, Lobectomy, Segmentectomy, Humans, Surgery
- Keywords
- video-assisted thoracoscopic surgery, lung cancer, three-dimensional reconstruction, three-dimensional simulation, open-source software
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Erik de LoosUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative 3D lung reconstruction | – | –Patients who were planned for an anatomical lung resection with preoperative 3D lung reconstruction from CT images |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred for a segmentectomy or lobectomy
Key inclusion criteria (1 listed)
- Patients with suspected or biopsy-proven lung cancer scheduled for video-assisted thoracoscopy surgery for lobectomy or segmentectomy
Key exclusion criteria (4 listed)
- Computed Tomography scan contained motion artifacts
- Surgery was canceled
- Planned surgery changed intraoperatively to another procedure
- Patients who did not provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Segmental lung nodule location
Time frame: Baseline and during surgery (at day 0)
Number of arteries to target lobe or segment
Time frame: Baseline and during surgery (at day 0)
Anatomical variations
Time frame: Baseline and during surgery (at day 0)
Potential change of surgery or surgical plan
Time frame: Single-point evaluation after surgery (at day 0)
Intraoperative use of 3D lung reconstruction
Time frame: Single-point evaluation after surgery (at day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- BackgroundJulious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 2005;4:287-91.
- BackgroundLewis JR, Sauro J. Item benchmarks for the system usability scale. J Usability Stud 2018;13.
- BackgroundBrooke J. SUS: a 'quick and dirty' usability. Usability Eval Ind 1996;189:189-94.
- Derived from this study: PubMed 39118878Laven IEWG, Oosterhoff VPS, Franssen AJPM, van Roozendaal LM, Hulsewe KWE, Vissers YLJ, de Loos ER. Evaluating three-dimensional lung reconstructions for thoracoscopic lung resections using open-source software: a pilot study. Transl Lung Cancer Res. 2024 Jul 30;13(7):1595-1608. doi: 10.21037/tlcr-24-134. Epub 2024 Jul 16.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author, ER de Loos, upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik de Loos, PhD principal investigator
Department of Surgery, Zuyderland Medical Center, Heerlen, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Thoracic Surgery, Video-Assisted, run by Erik de Loos at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Score (time frame: Single-point evaluation after surgery (at day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06132607, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.