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

Segmentectomy Clinical Trial

— DRIVATS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04004494
• Other study ID #: RTS-008
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Segmentectomy

Intervention

Other:
• 3D reconstruction
3-dimensional computed tomography reconstruction guided VATS segmentectomy

Locations

Country	Name	City	State
China	Union Hospital of Fujian medical university	Fujian	Fujian
China	Guangdong General Hospital	Guangdong	Guangdong
China	Ruijin Hospital, Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Ruijin Hospital	Guangdong Provincial People's Hospital, Union hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total hospitalization expenditures	cost in hospital	postoperative in-hospital stay up to 30 days
Other	Anatomical variations	Rate of anatomical variation of segmental bronchus and pulmonary vessel in Chinese population	During surgery
Primary	operative time	the time of operation	During surgery
Secondary	blood loss	Amount of intraoperative blood loss	During surgery
Secondary	conversion rate	the rate of conversion to open surgery in the operation	During surgery
Secondary	operative accident event	the accident event happened in operative. For example, a segmentectomy is converted to a lobectomy	During surgery
Secondary	Incidence of postoperative complications	mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula	Postoperative in-hospital stay up to 30 days
Secondary	Postoperative hospital stay	length of stay in hospitalization	Up to 24 weeks
Secondary	Duration of chest tube placement	Duration of chest tube placement	Up to 4 weeks
Secondary	30-day mortality	30-day mortality after surgery	Postoperative in-hospital stay up to 30 days
Secondary	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
Secondary	Overall survival (OS)	Up to the date of death of any causes since the date of randomization	up to 60 months
Secondary	Disease-free survival (DFS)	Up to the date of disease recurrence since the date of randomization	up to 60 months
Secondary	Preoperative lung function	forced expiratory volume at one second(FEV1) in litre, maximal voluntary ventilation (MVV) in litre	Baseline
Secondary	Postoperative lung function	forced expiratory volume at one second(FEV1) in litre, maximal voluntary ventilation (MVV) in litre	at the 3rd month after surgery
Secondary	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