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SegmentectomyDRIVATSNCT04004494

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

A study testing 3D reconstruction in people with Segmentectomy, run by Ruijin Hospital at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Segmentectomy
What is being tested?
3D reconstruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
3 sitesChina
Study dates
1 Jul 2019to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Union Hospital of Fujian medical university

    Fujian, Fujian, 350001

  • Guangdong General Hospital

    Guangdong, Guangdong, 510080

  • Ruijin Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: Three-dimensional Computed Tomography Reconstruction for Operative Planning in 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.

Read the 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.

Conditions
Segmentectomy
Being tested
3D reconstruction
Keywords
segmentectomy, Video-assisted thoracoscopic surgery, lung cancer, ground-glass opacity
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D reconstructionOther

    3-dimensional computed tomography reconstruction guided VATS segmentectomy

Study groups in NCT04004494
Study groupRoleWhat they receive
3D ReconstructionExperimentalChest 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.
Receives: Other: 3D reconstruction
Chest computed tomographyNo interventionChest contrast-enhanced computed tomography will be performed preoperatively. Video-assisted segmentectomy will be performed based on the image of preoperative chest CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. operative time

    the time of operation

    Measured: During surgery

Secondary outcomes (13)

  1. blood loss

    Amount of intraoperative blood loss

    Measured: During surgery

  2. conversion rate

    the rate of conversion to open surgery in the operation

    Measured: During surgery

  3. operative accident event

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

    Measured: During surgery

  4. Incidence of postoperative complications

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

    Measured: Postoperative in-hospital stay up to 30 days

  5. Postoperative hospital stay

    length of stay in hospitalization

    Measured: Up to 24 weeks

  6. Duration of chest tube placement

    Duration of chest tube placement

    Measured: Up to 4 weeks

  7. 30-day mortality

    30-day mortality after surgery

    Measured: Postoperative in-hospital stay up to 30 days

  8. dissection of lymph nodes

    including overall lymph node count, number of stations dissected and number of lymph nodes in each lymph node station

    Measured: 2 weeks after surgery

  9. Overall survival (OS)

    Up to the date of death of any causes since the date of randomization

    Measured: up to 60 months

  10. Disease-free survival （DFS）

    Up to the date of disease recurrence since the date of randomization

    Measured: up to 60 months

  11. Preoperative lung function

    forced expiratory volume at one second（FEV1） in litre, maximal voluntary ventilation （MVV） in litre

    Measured: Baseline

  12. Postoperative lung function

    forced expiratory volume at one second（FEV1） in litre, maximal voluntary ventilation （MVV） in litre

    Measured: at the 3rd month after surgery

  13. Incidence of change of surgical plan

    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

    Measured: During surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2019
  2. Study start1 Jul 2019
  3. Primary completion31 Oct 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04004494
Sponsor's protocol ID
RTS-008
Acronym
DRIVATS
Status last verified
May 2024
First submitted
23 Jun 2019
Last updated
24 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36311929

Questions about this trial

What is this clinical trial studying?

A study testing 3D reconstruction in people with Segmentectomy, run by Ruijin Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

operative time (time frame: During surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04004494, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.

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