Morphologic Study of the Intersegmental Plane After Fully Thoracoscopic Segmentectomy

Institut Mutualiste Montsouris

Status: Unknown

Conditions: Video-assisted Thoracoscopic Surgery (VATS); Segmentectomy

Treatments: Other: thoracic densitometry with contrast

Study type: Interventional

Funder types: Other

Identifiers

NCT03227380

THO-2016-01

Details and patient eligibility

About

The objective of this study is to determine whether stapling adversely affects the pulmonary parenchyma and the vascularisation of the adjacent segments. The aim of our work is to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy, 3 or 6 months post-surgery. the investigator will assess venous drainage and the arterial vascularisation of the remaining segments, possible modifications of the adjacent parenchyma and whether there is a defect of pleuro-pulmonary adhesion (residual pneumothorax).

Full description

Scheduled anatomical segmentectomies are increasingly popular, due to the development of minimally invasive techniques, the increased incidence of early-stage tumours, and the possibility of caring for patients with compromised health and/or limited respiratory function without compromising the oncological outcome, compared to current alternatives such as stereotactic ablative radiotherapy (1).

One of the challenges in the development of the thoracoscopic segmentectomy technique we have published (2-5) is the orientation (6-7) and the division of the intersegmental plane, by contrast to segmentectomy by thoracotomy where this is helped by palpation and the manual traction which can be used on the segment, along the intersegmental vein. The most commonly used technique to separate two adjacent segments remains stapling, despite its high cost and sometimes giving a less anatomical section, with a risk to encroach on the intersegmental vein. Moreover, there can be a partial plicator of the spared segment(s) which could in theory make them less functional.

We have however shown that the postoperative morbidity and mortality rates were much lower than that of patients who had a thoracotomy, dropping from 42% for thoracotomies to 16% for thoracoscopies, the surgical approach being an independent predictive factor for postoperative complications (8).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrolment in the study will be offered to all patients having undergone a programmed scheduled video-assisted thoracoscopic segmentectomy, whatever the aetiology.
• Men or women aged 18 years or greater
• Absence of severe hepatic insufficiency
• signed and dated informed consent
• candidate for segmentectomy
• Registration in a national healthcare system.
• Women of child-bearing age using effective oral or barrier contraception

Exclusion criteria

• Proven intolerance to iodinated contrast agents
• Know allergy or non-controlled asthma - pregnancy
• Severe hepatic insufficiency (creatinine clearance < 30ml/min, by Cockroft's method)
• Pregnant or breastfeeding women
• Patients under trusteeship or curators
• Diabetic patients or patients receiving oral antidiabetic medication

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

radiological evaluation

Other group

Description:

to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy

Treatment:

Other: thoracic densitometry with contrast