NCT03628326

Brief Summary

Anatomic variations of the pulmonary arterial tree can cause technical difficulties during pulmonary lobectomy in general and video-assisted thoracic surgery (VATS). Using CT angiography and 3D reconstruction, the investigators sought to identify anatomic variations of the pulmonary arterial tree and assess their respective frequencies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

July 31, 2018

Last Update Submit

August 9, 2018

Conditions

Keywords

Pulmonary artery3D reconstructionVideo-assisted thoracic surgery lobectomyCT angiographyAnatomic variation

Outcome Measures

Primary Outcomes (1)

  • Use CT angiography and 3D reconstruction

    The primary objective of the present study was to use CT angiography and 3D reconstruction to assess the pulmonary arterial tree and its anatomic variations in patients having undergone VATS lobectomy for stage I-II lung cancer. The investigators studied patients having undergone VATS lobectomy for stage I-II lung cancer at the Amiens University Hospital's Department of Thoracic Surgery between October 2012 and March 2014. The investigators performed 3D reconstruction of the pulmonary arterial tree on the CT angiography data set acquired during preoperative work-up. Patients having undergone CT angiography in another hospital, those not having undergone CT angiography of the arterial tree, and those having been operated on more than once for lung cancer were excluded from the study.

    18-month

Study Arms (2)

right lung resection

The investigators sought to identify anatomic variations of the pulmonary arterial tree and assess their respective frequencies.

Other: Pulmonary arterial tree

left lung resection

The investigators sought to identify anatomic variations of the pulmonary arterial tree and assess their respective frequencies.

Other: Pulmonary arterial tree

Interventions

The investigators performed 3D reconstruction of the pulmonary arterial tree on the CT angiography data set acquired during preoperative work-up.

left lung resectionright lung resection

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators studied patients having undergone VATS lobectomy for stage I-II lung cancer at the Amiens University Hospital's Department of Thoracic Surgery between October 2012 and March 2014. We performed 3D reconstruction of the pulmonary arterial tree on the CT angiography data set acquired during preoperative work-up.

You may qualify if:

  • Any major patient aged 18 years and over who has undergone oncological lung lobectomy for non-small-cell lung cancer located in the thoracic surgery department of the University Hospital of Amiens.
  • Nosologic criteria and related to acts: The pathology has already been diagnosed or suspected, and the surgical indication has been validated in the Multidisciplinary Thoracic Oncology Concertation Meeting according to national recommendations.
  • These patients will be collected in a database already referenced in the register of the establishment of the University Hospital of Amiens under the reference DRCI T38

You may not qualify if:

  • Criteria relating to the population:
  • Patient under guardianship or curatorship
  • Pathology Criteria: Patient with no pulmonary neoplastic disease, patient with locally advanced or metastatic bronchopulmonary cancer
  • Criteria relating to the acts: the criteria altering the surgical specimen and thus its anatomical study: patient having had an extemporaneous examination, patient with the antecedents of ipsilateral pulmonary surgery and / or need of decortication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stenosis, Pulmonary Artery

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Frederic Marçon, MD

    CHU AMIENS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 14, 2018

Study Start

April 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share