- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03628326
Evaluation of Visceral Pleural Lumbar Lymphatic Drainage (SEGPUL)
August 9, 2018 updated by: Centre Hospitalier Universitaire, Amiens
Is Pulmonary Segmentectomy an Anatomical Resection? Evaluation of Visceral Pleural Lumbar Lymphatic Drainage - Anatomo-clinical Correlation.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Purpose 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.
Methods the investigators retrospectively studied 88 pulmonary arterial trees in 44 patients having undergone VATS lobectomy for lung cancer over an 18-month period in Amiens University Hospital's Department of Thoracic Surgery.
Each CT angiography with 3D reconstruction of the pulmonary arterial tree was performed by two experienced operators, according to a standardized procedure.
Study Type
Observational
Enrollment (Actual)
44
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
right lung resection
The investigators sought to identify anatomic variations of the pulmonary arterial tree and assess their respective frequencies.
|
The investigators performed 3D reconstruction of the pulmonary arterial tree on the CT angiography data set acquired during preoperative work-up.
|
left lung resection
The investigators sought to identify anatomic variations of the pulmonary arterial tree and assess their respective frequencies.
|
The investigators performed 3D reconstruction of the pulmonary arterial tree on the CT angiography data set acquired during preoperative work-up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use CT angiography and 3D reconstruction
Time Frame: 18-month
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frederic Marçon, MD, CHU Amiens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
July 31, 2018
First Submitted That Met QC Criteria
August 9, 2018
First Posted (Actual)
August 14, 2018
Study Record Updates
Last Update Posted (Actual)
August 14, 2018
Last Update Submitted That Met QC Criteria
August 9, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI2016-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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