Evaluation of Visceral Pleural Lumbar Lymphatic Drainage (SEGPUL)

• ClinicalTrials.gov Identifier: NCT03628326
• Recruitment Status: Completed
• First Posted: August 14, 2018
• Last Update Posted: August 14, 2018
• Sponsor: Centre Hospitalier Universitaire, Amiens
• Information provided by (Responsible Party): Centre Hospitalier Universitaire, Amiens

Study Description

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.

Condition or disease	Intervention/treatment
Pulmonary Artery Stenosis	Other: Pulmonary arterial tree

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 Design

• Study Type: Observational
• Actual Enrollment: 44 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Is Pulmonary Segmentectomy an Anatomical Resection? Evaluation of Visceral Pleural Lumbar Lymphatic Drainage - Anatomo-clinical Correlation.
• Actual Study Start Date: April 1, 2016
• Actual Primary Completion Date: August 1, 2017
• Actual Study Completion Date: August 1, 2017

Groups and Cohorts

Group/Cohort	Intervention/treatment
right lung resection; The investigators sought to identify anatomic variations of the pulmonary arterial tree and assess their respective frequencies.	Other: Pulmonary arterial tree; 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.	Other: Pulmonary arterial tree; The investigators performed 3D reconstruction of the pulmonary arterial tree on the CT angiography data set acquired during preoperative work-up.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

• Principal Investigator: Frederic Marçon, MD; CHU AMIENS

More Information

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT03628326
• Other Study ID Numbers: RNI2016-01
• First Posted: August 14, 2018
• Last Update Posted: August 14, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:

Pulmonary artery; 3D reconstruction; Video-assisted thoracic surgery lobectomy; CT angiography; Anatomic variation

Additional relevant MeSH terms:

Stenosis, Pulmonary Artery; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases