Skip to main content
OpenTrials
Completed

NCT Number: NCT04004494

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Union Hospital of Fujian medical university, Fujian, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age older than 18 years;
  • 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.

  • Adequate cardiac function, respiratory function, liver function and renal function for anesthesia and VATS segmentectomy.
  • American Society of Anesthesiologists (ASA) score: Grade I-III.
  • Patients who can coordinate the treatment and research and sign the informed consent.

Exclusion criteria

  • Patients with a significant medical condition which is thought unlikely to tolerate the surgery. For example, cardiac disease, significant liver and renal function disorder.
  • Patients with psychiatric disease who are expected lack of compliance with the protocol.
  • Patients have history of chest trauma or surgery on ipsilateral chest which may cause pleural adhesion.

Treatment and study plan

3D reconstruction

Other

3-dimensional computed tomography reconstruction guided VATS segmentectomy

Primary outcomes

  1. operative time

    Time frame: During surgery

    the time of operation

Secondary outcomes

  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

  13. 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

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Guangdong Provincial People's Hospital
  • Union hospital of Fujian Medical University

Registry information

Official study title

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

Acronym: DRIVATS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 2, 2019
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.