3D Reconstruction in Video-assisted Thoracoscopic Surgery (VATS) Segmentectomy (DRIVATS)

Three-dimensional Computed Tomography Reconstruction for Operative Planning in VATS Segmentectomy

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.

Study Overview

• Status: Completed
• Conditions: Segmentectomy
• Intervention / Treatment: Other: 3D reconstruction

Detailed Description

Lung cancer has been the most serious malignancy around the world which has the highest morbidity and mortality amount all the malignant tumors. Due to the wide spread of lung cancer screening, more and more early stage lung cancer patients have been diagnosed. Video-assisted segmentectomy is a standard surgical procedure in treating early stage peripheral non-small cell lung cancer (NSCLC). However, anatomical variations of pulmonary vessel may cause serious problems, for example unexpected bleed during surgery. Three-dimensional computed tomography (CT), which is reconstructed based on the standard chest CT image, presents 3D images of pulmonary vessels and the tracheobronchial tree and therefore helps operative planning. There are several retrospective studies addressed the importance of 3-dimensional CT in the field of pulmonary segmentectomy. And the aim of this multicenter randomized controlled trial is to compare the usefulness of 3-dimensional CT and standard chest CT in preoperative planning of video-assisted segmentectomy.

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fujian, Fujian, China, 350001
      • Union Hospital of Fujian Medical University
  • Guangdong
    • Guangdong, Guangdong, China, 510080
      • Guangdong General Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age older than 18 years;

2. 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.

3. Adequate cardiac function, respiratory function, liver function and renal function for anesthesia and VATS segmentectomy.
4. American Society of Anesthesiologists (ASA) score: Grade I-III.
5. Patients who can coordinate the treatment and research and sign the informed consent.

Exclusion Criteria:

1. Patients with a significant medical condition which is thought unlikely to tolerate the surgery. For example, cardiac disease, significant liver and renal function disorder.
2. Patients with psychiatric disease who are expected lack of compliance with the protocol.
3. Patients have history of chest trauma or surgery on ipsilateral chest which may cause pleural adhesion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D Reconstruction; Chest 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.	Other: 3D reconstruction; 3-dimensional computed tomography reconstruction guided VATS segmentectomy
No Intervention: Chest computed tomography; Chest contrast-enhanced computed tomography will be performed preoperatively. Video-assisted segmentectomy will be performed based on the image of preoperative chest CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	the time of operation	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of change of surgical plan	Surgical plan is made based of the image of standard chest computed tomography or three-dimensional computed tomography, the targeted segmental bronchus and pulmonary vessels are decided preoperatively. Change of surgical plan is recorded when the actually resected bronchus and vessels are different to those in the preoperative surgical plan	During surgery
blood loss	Amount of intraoperative blood loss	During surgery
conversion rate	the rate of conversion to open surgery in the operation	During surgery
operative accident event	the accident event happened in operative. For example, a segmentectomy is converted to a lobectomy	During surgery
Incidence of postoperative complications	mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula	Postoperative in-hospital stay up to 30 days
Postoperative hospital stay	length of stay in hospitalization	Up to 24 weeks
Duration of chest tube placement	Duration of chest tube placement	Up to 4 weeks
30-day mortality	30-day mortality after surgery	Postoperative in-hospital stay up to 30 days
dissection of lymph nodes	including overall lymph node count, number of stations dissected and number of lymph nodes in each lymph node station	2 weeks after surgery
Overall survival (OS)	Up to the date of death of any causes since the date of randomization	up to 60 months
Disease-free survival （DFS）	Up to the date of disease recurrence since the date of randomization	up to 60 months
Preoperative lung function	forced expiratory volume at one second（FEV1） in litre, maximal voluntary ventilation （MVV） in litre	Baseline
Postoperative lung function	forced expiratory volume at one second（FEV1） in litre, maximal voluntary ventilation （MVV） in litre	at the 3rd month after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total hospitalization expenditures	cost in hospital	postoperative in-hospital stay up to 30 days
Anatomical variations	Rate of anatomical variation of segmental bronchus and pulmonary vessel in Chinese population	During surgery

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Guangdong Provincial People's Hospital; Union hospital of Fujian Medical University
• Investigators: Study Director: He-Cheng Li, doctor, Ruijin Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 23, 2019
• First Submitted That Met QC Criteria: June 29, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: lung cancer; segmentectomy; Video-assisted thoracoscopic surgery; ground-glass opacity
• Other Study ID Numbers: RTS-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No