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出境医 / 临床实验 / 3D Reconstruction in Video-assisted Thoracoscopic Surgery (VATS) Segmentectomy

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

Study Description
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.
Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

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

Locations
Layout table for location information
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
Layout table for investigator information
Study Director: He-Cheng Li, doctor Ruijin Hospital
Tracking Information
First Submitted Date  ICMJE June 23, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date December 1, 2020
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2019)
  • operative time [ Time Frame: During surgery ]
    the time of operation
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2019)
  • blood loss [ Time Frame: During surgery ]
    Amount of intraoperative blood loss
  • conversion rate [ Time Frame: During surgery ]
    the rate of conversion to open surgery in the operation
  • operative accident event [ Time Frame: During surgery ]
    the accident event happened in operative. For example, a segmentectomy is converted to a lobectomy
  • 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
  • Postoperative hospital stay [ Time Frame: Up to 24 weeks ]
    length of stay in hospitalization
  • Duration of chest tube placement [ Time Frame: Up to 4 weeks ]
    Duration of chest tube placement
  • 30-day mortality [ Time Frame: Postoperative in-hospital stay up to 30 days ]
    30-day mortality after surgery
  • 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
  • Overall survival (OS) [ Time Frame: up to 60 months ]
    Up to the date of death of any causes since the date of randomization
  • Disease-free survival （DFS） [ Time Frame: up to 60 months ]
    Up to the date of disease recurrence since the date of randomization
  • Preoperative lung function [ Time Frame: Baseline ]
    forced expiratory volume at one second（FEV1） in litre, maximal voluntary ventilation （MVV） in litre
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2019)
  • blood loss [ Time Frame: During surgery ]
    Amount of intraoperative blood loss
  • conversion rate [ Time Frame: During surgery ]
    the rate of conversion to open surgery in the operation
  • operative accident event [ Time Frame: During surgery ]
    the accident event happened in operative. For example, a segmentectomy is converted to a lobectomy
  • 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
  • Postoperative hospital stay [ Time Frame: Up to 24 weeks ]
    length of stay in hospitalization
  • Duration of chest tube placement [ Time Frame: Up to 4 weeks ]
    Duration of chest tube placement
  • 30-day mortality [ Time Frame: Postoperative in-hospital stay up to 30 days ]
    30-day mortality after surgery
  • 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
  • Overall survival (OS) [ Time Frame: up to 60 months ]
    Up to the date of death of any causes since the date of randomization
  • Progression-free survival (PFS) [ Time Frame: up to 60 months ]
    Up to the date of disease recurrence since the date of randomization
  • Preoperative lung function [ Time Frame: Baseline ]
    forced expiratory volume at one second（FEV1） in litre, maximal voluntary ventilation （MVV） in litre
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: June 29, 2019)
  • Total hospitalization expenditures [ Time Frame: postoperative in-hospital stay up to 30 days ]
    cost in hospital
  • Anatomical variations [ Time Frame: During surgery ]
    Rate of anatomical variation of segmental bronchus and pulmonary vessel in Chinese population
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE 3D Reconstruction in Video-assisted Thoracoscopic Surgery (VATS) Segmentectomy
Official Title  ICMJE Three-dimensional Computed Tomography Reconstruction for Operative Planning in VATS Segmentectomy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Segmentectomy
Intervention  ICMJE Other: 3D reconstruction
3-dimensional computed tomography reconstruction guided VATS segmentectomy
Study Arms  ICMJE
  • 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.
    Intervention: Other: 3D reconstruction
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2019) 		200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kai Chen, doctor 00862164370045 ext 666112 dr.chenkai@hotmail.com
Contact: Yu-Yan Zheng, doctor 00862164370045 ext 666112 yuyanzheng@outlook.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004494
Other Study ID Numbers  ICMJE RuijinH-3D
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hecheng Li M.D., Ph.D, Ruijin Hospital
Study Sponsor  ICMJE Ruijin Hospital
Collaborators  ICMJE
  • Union hospital of Fujian Medical University
  • Guangdong Provincial People's Hospital
Investigators  ICMJE
Study Director: He-Cheng Li, doctor Ruijin Hospital
PRS Account Ruijin Hospital
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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