No registrations found.
ID
Source
Brief title
Health condition
Lung carcinoma (NSCLC), benign pathologie (bronchiectasis, hamartoma) or metastatic pulmonary lesion
Sponsors and support
Intervention
Outcome measures
Primary outcome
Additional value of advanced imaging (based on 3D-VR and AI technology) over 2D-CT
Secondary outcome
Percentage change of plan due to 3D-VR planning, percentage more lung sparing, preoperative planning time of 3D-VR and 2D-CT, consensus between different participating centers. Similarities between parameters in 3D-VR and real-life, Ease-of-use of 3D-VR software, perioperative outcomes of VR-guided segmentectomies.
Background summary
VR-guided segmentectomies have shown a 50% change of surgical plan compared to 2D-CT planned segmentectomies. In this multicenter study, 100 patients will be included, coming from 6 to 7 different centers in The Netherlands, to determine the additional value of advanced imaging (based on 3D-VR and artificial intelligence) compared to conventional CT planning on the surgical strategy for lung segmentectomy. During 1 year, patients with early stage lung cancer, metastatic pulmonary lesions or benign pathology, suitable for segment resection based on multidisciplinary discussion, will be included. First, all centers will set up an operative plan based on 2D-CT (approach, which segments need to be resected etc). Meanwhile, researchers make the conventional CT VR-ready and redistribute the 3D-VR images over all participating centers. Then, all centers will make a new operative plan. Operating center is blinded to the results of other centers, but can adjust its surgical plan based on the 3D-VR images. Afterwards, perioperative outcomes and pathological outcomes will be collected.
Study objective
Additional value of 3D-VR over 2D-CT will show that lung surgery will be in some cases more lung sparing or will result in better preoperative planning by having more information about important parameters (resection margin, anatomic variation) that will make lung resection surgery more safe en tumor specific will result in an oncological better radical resection.
Study design
The primary outcome: 3D-VR planning vs 2D-CT planning and its operative plan will be determined 1 to 2 weeks after patient inclusion and before surgery. The perioperative parameters will be collected 1 month after surgery (to include all complications that could have occurred in the 30 days after surgery).
Inclusion criteria
Indication for lung segment resection. Patient older than 18 years, operation planned in one of participating centers. Diagnostic CT thorax with max slide width of 1,5mm available. (High suspicion of ) lung carcinoma NSCLC stage 1A1/1A2 (cT1a/bN0M0) not centrally located and suitable for segment resection, or benign pathology (ie hamartoma) suitable for segment resection, or metastatic pulmonary lesion (extra thoracic origin or reoccuring lung carcinoma) suitable for segment resection
Exclusion criteria
No informed consent for using VR as preoperative tool, patient wish for lobectomy instead of segmentectomy, not suitable for segmentectomy based on preoperative screening
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9767 |
Other | METC Erasmus MC (+ METC of all participating centers will follow) : MEC-2020-0702 |