Clinical trial NCT04004494: 3D Reconstruction in Video-assisted Thoracoscopic Surgery (VATS) Segmentectomy
Official title: Three-dimensional Computed Tomography Reconstruction for Operative Planning in VATS Segmentectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Segmentectomy
Keywords: segmentectomy
Video-assisted thoracoscopic surgery
lung cancer
ground-glass opacity
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Union hospital of Fujian Medical University
name: Guangdong Provincial People's Hospital
First posted: 2019-07-02
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: operative time
timeFrame: During surgery
Secondary outcomes:
measure: blood loss
timeFrame: During surgery
measure: conversion rate
timeFrame: During surgery
measure: operative accident event
timeFrame: During surgery
measure: Incidence of postoperative complications
timeFrame: Postoperative in-hospital stay up to 30 days
measure: Postoperative hospital stay
timeFrame: Up to 24 weeks
measure: Duration of chest tube placement
timeFrame: Up to 4 weeks
measure: 30-day mortality
timeFrame: Postoperative in-hospital stay up to 30 days
measure: dissection of lymph nodes
timeFrame: 2 weeks after surgery
measure: Overall survival (OS)
timeFrame: up to 60 months
measure: Disease-free survival （DFS）
timeFrame: up to 60 months
measure: Preoperative lung function
timeFrame: Baseline
measure: Postoperative lung function
timeFrame: at the 3rd month after surgery
measure: Incidence of change of surgical plan
timeFrame: During surgery
Other outcomes:
measure: Total hospitalization expenditures
timeFrame: postoperative in-hospital stay up to 30 days
measure: Anatomical variations
timeFrame: During surgery
Locations:
city: Fujian
country: China
facility: Union Hospital of Fujian medical university
state: Fujian
city: Guangdong
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: He-Cheng Li, doctor
role: STUDY_DIRECTOR
References:
citation: 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.