3D Reconstruction in Video-assisted Thoracoscopic Surgery (VATS) Segmentectomy
DRIVATS
Three-dimensional Computed Tomography Reconstruction for Operative Planning in VATS Segmentectomy
1 other identifier
interventional
191
1 country
3
Brief Summary
Anatomical variations of pulmonary vessel may cause serious problems during pulmonary segmentectomy. Three-dimensional （3D）computed tomography (CT) presents 3D images of pulmonary vessels and the tracheobronchial tree and may help operative planning. Retrospective studies have identified the importance of 3-dimensional CT in the field of pulmonary segmentectomy. And the aim of this study is to compare the usefulness of 3-dimensional CT with standard chest CT in preoperative planning of video-assisted segmentectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
3 active sites
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
First Submitted
Initial submission to the registry
June 23, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 24, 2024
May 1, 2024
4.3 years
June 23, 2019
May 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
operative time
the time of operation
During surgery
Secondary Outcomes (13)
blood loss
During surgery
conversion rate
During surgery
operative accident event
During surgery
Incidence of postoperative complications
Postoperative in-hospital stay up to 30 days
Postoperative hospital stay
Up to 24 weeks
- +8 more secondary outcomes
Other Outcomes (2)
Total hospitalization expenditures
postoperative in-hospital stay up to 30 days
Anatomical variations
During surgery
Study Arms (2)
3D Reconstruction
EXPERIMENTALChest contrast-enhanced computed tomography will be performed preoperatively, and 3-dimensional reconstruction will be formed based on the data of chest CT. Video-assisted segmentectomy will be performed guided by the image of 3-dimensional CT. IPS-lung software (Shenzhen Yorktal Digital Medical Imaging Technology Company, Shenzhen, China) will be used preoperatively to construct a 3D-image to ascertain the position and structure of targeted segmental blood vessels and bronchi.
Chest computed tomography
NO INTERVENTIONChest contrast-enhanced computed tomography will be performed preoperatively. Video-assisted segmentectomy will be performed based on the image of preoperative chest CT
Interventions
3-dimensional computed tomography reconstruction guided VATS segmentectomy
Eligibility Criteria
You may qualify if:
- Age older than 18 years;
- Pulmonary nodules or ground glass opacification （GGO） found in chest CT examination, and conform with indications for segmentectomy:
- Peripheral nodule 0.8-2 cm with at least one of the following:
- i. Histology of adenocarcinoma in situ; ii. Nodule has ≥50% ground-glass appearance on CT; iii. Radiologic surveillance confirms a long doubling time (≥400 days). Segmentectomy should achieve parenchymal resection margins ≥2 cm or ≥ the size of the nodule.
- Adequate cardiac function, respiratory function, liver function and renal function for anesthesia and VATS segmentectomy.
- American Society of Anesthesiologists (ASA) score: Grade I-III.
- Patients who can coordinate the treatment and research and sign the informed consent.
You may not qualify if:
- Patients with a significant medical condition which is thought unlikely to tolerate the surgery. For example, cardiac disease, significant liver and renal function disorder.
- Patients with psychiatric disease who are expected lack of compliance with the protocol.
- Patients have history of chest trauma or surgery on ipsilateral chest which may cause pleural adhesion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
- Union hospital of Fujian Medical Universitycollaborator
- Guangdong Provincial People's Hospitalcollaborator
Study Sites (3)
Union Hospital of Fujian medical university
Fujian, Fujian, 350001, China
Guangdong General Hospital
Guangdong, Guangdong, 510080, China
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Related Publications (1)
Niu Z, Chen K, Jin R, Zheng B, Gong X, Nie Q, Jiang B, Zhong W, Chen C, Li H. Three-dimensional computed tomography reconstruction in video-assisted thoracoscopic segmentectomy (DRIVATS): A prospective, multicenter randomized controlled trial. Front Surg. 2022 Oct 13;9:941582. doi: 10.3389/fsurg.2022.941582. eCollection 2022.
PMID: 36311929DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
He-Cheng Li, doctor
Ruijin Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 23, 2019
First Posted
July 2, 2019
Study Start
July 1, 2019
Primary Completion
October 31, 2023
Study Completion
December 31, 2023
Last Updated
May 24, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share