Morphologic Study of the Intersegmental Plane After Fully Thoracoscopic Segmentectomy

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).

Study Overview

• Status: Unknown
• Conditions: Segmentectomy; Video-assisted Thoracoscopic Surgery (VATS)
• Intervention / Treatment: Other: thoracic densitometry with contrast

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Institut Mutualiste Montsouris
    • Contact: Isabelle Sauret

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: radiological evaluation; to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy	Other: thoracic densitometry with contrast; injected CT scan at 3 or 6 months after segmentectomy VATS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The measure of the remaining segments after stapling the intersegmental plane by injected CT scan	The aim of investigators work is to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy, from 3 to 6 months post-surgery. The investigators 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). The radiological evaluation criteria will be: Presence and quantification of a defect in pulmonary expansion (residual pneumothorax); Abnormal venous and arterial vascularisation of the remaining segments; Defect of the pulmonary parenchyma in contact with the staples line (atelectasis, vascularisation defect)	3 or 6 months after surgery

Collaborators and Investigators

• Sponsor: Institut Mutualiste Montsouris

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2017
• Primary Completion (Anticipated): February 20, 2018
• Study Completion (Anticipated): August 30, 2018

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: THO-2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No