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

Ruijin Hospital191 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

191

Conditions

Segmentectomy

Interventions

3D reconstructionOTHER

3-dimensional computed tomography reconstruction guided VATS segmentectomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

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 Municipality, China

Outcomes

Primary Outcomes

operative time

the time of operation

Time frame: During surgery

Secondary Outcomes

blood loss

Amount of intraoperative blood loss

Time frame: During surgery

conversion rate

the rate of conversion to open surgery in the operation

Time frame: During surgery

operative accident event

the accident event happened in operative. For example, a segmentectomy is converted to a lobectomy

Time frame: During surgery

Incidence of postoperative complications

mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula

Time frame: Postoperative in-hospital stay up to 30 days

Postoperative hospital stay

length of stay in hospitalization

Time frame: Up to 24 weeks

Duration of chest tube placement

Time frame: Up to 4 weeks

30-day mortality

30-day mortality after surgery

Time frame: 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

Data from ClinicalTrials.gov

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