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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004494
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborators:
Union hospital of Fujian Medical University
Guangdong Provincial People's Hospital
Information provided by (Responsible Party):
Hecheng Li M.D., Ph.D, Ruijin Hospital

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.

Condition or disease Intervention/treatment Phase
Segmentectomy Other: 3D reconstruction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Three-dimensional Computed Tomography Reconstruction for Operative Planning in VATS Segmentectomy
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. operative time [ Time Frame: During surgery ]
    the time of operation

  2. Incidence of change of surgical plan [ Time Frame: During surgery ]
    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


Secondary Outcome Measures :
  1. blood loss [ Time Frame: During surgery ]
    Amount of intraoperative blood loss

  2. conversion rate [ Time Frame: During surgery ]
    the rate of conversion to open surgery in the operation

  3. operative accident event [ Time Frame: During surgery ]
    the accident event happened in operative. For example, a segmentectomy is converted to a lobectomy

  4. Incidence of postoperative complications [ Time Frame: Postoperative in-hospital stay up to 30 days ]
    mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula

  5. Postoperative hospital stay [ Time Frame: Up to 24 weeks ]
    length of stay in hospitalization

  6. Duration of chest tube placement [ Time Frame: Up to 4 weeks ]
    Duration of chest tube placement

  7. 30-day mortality [ Time Frame: Postoperative in-hospital stay up to 30 days ]
    30-day mortality after surgery

  8. dissection of lymph nodes [ Time Frame: 2 weeks after surgery ]
    including overall lymph node count, number of stations dissected and number of lymph nodes in each lymph node station

  9. Overall survival (OS) [ Time Frame: up to 60 months ]
    Up to the date of death of any causes since the date of randomization

  10. Disease-free survival (DFS) [ Time Frame: up to 60 months ]
    Up to the date of disease recurrence since the date of randomization

  11. Preoperative lung function [ Time Frame: Baseline ]
    forced expiratory volume at one second(FEV1) in litre, maximal voluntary ventilation (MVV) in litre

  12. Postoperative lung function [ Time Frame: at the 3rd month after surgery ]
    forced expiratory volume at one second(FEV1) in litre, maximal voluntary ventilation (MVV) in litre


Other Outcome Measures:
  1. Total hospitalization expenditures [ Time Frame: postoperative in-hospital stay up to 30 days ]
    cost in hospital

  2. Anatomical variations [ Time Frame: During surgery ]
    Rate of anatomical variation of segmental bronchus and pulmonary vessel in Chinese population



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 cm-2 cm with at least one of the following:

    i. Minimally invasive adenocarcinoma (MIA) histology; 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.
  4. Patients who cannot tolerate contrast-enhanced computed tomography, for example patients who are allergic to iodine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004494


Contacts
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Contact: Kai Chen, doctor 00862164370045 ext 666112 dr.chenkai@hotmail.com
Contact: Yu-Yan Zheng, doctor 00862164370045 ext 666112 yuyanzheng@outlook.com

Locations
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China, Fujian
Union Hospital of Fujian medical university Recruiting
Fujian, Fujian, China, 350001
Contact: Bing Zheng, doctor    +86 15959002753      
China, Guangdong
Guangdong General Hospital Not yet recruiting
Guangdong, Guangdong, China, 510080
Contact: Jiatao Zhang, doctor    18820792959    18820792959@163.com   
China, Shanghai
Ruijin Hospital, Shanghai JiaoTong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Kai Chen, doctor    00862164370045 ext 666112    dr.chenkai@hotmail.com   
Contact: Yu-Yan Zheng, doctor    00862164370045 ext 666112    yuyanzheng@outlook.com   
Sponsors and Collaborators
Ruijin Hospital
Union hospital of Fujian Medical University
Guangdong Provincial People's Hospital
Investigators
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Study Director: He-Cheng Li, doctor Ruijin Hospital
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Responsible Party: Hecheng Li M.D., Ph.D, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04004494    
Other Study ID Numbers: RuijinH-3D
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hecheng Li M.D., Ph.D, Ruijin Hospital:
segmentectomy
Video-assisted thoracoscopic surgery
lung cancer
ground-glass opacity