Morphologic Study of the Intersegmental Plane After Fully Thoracoscopic Segmentectomy

NCT03227380 | Unknown DMC

• 1 other identifier: THO-2016-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Video-assisted Thoracoscopic Surgery (VATS); Segmentectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

radiological evaluation

OTHER

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

Interventions

thoracic densitometry with contrast OTHER

injected CT scan at 3 or 6 months after segmentectomy VATS

radiological evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead

Study Sites (2)

Institut Mutualiste montsouris

Paris, 75014, France

RECRUITING

Institut mutualiste montsouris

Paris, 75014, France

RECRUITING

MeSH Terms

Interventions

Contrast Media

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Central Study Contacts

Agathe SEGUIN-GIVELET, MD

CONTACT

0156616240; agathe.seguin-givelet@imm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients undergo anatomic segmentectomy by video-assisted thoracoscopic surgery (VATS)

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: July 24, 2017
• Study Start: March 31, 2017
• Primary Completion: February 20, 2018
• Study Completion: August 30, 2018
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

FR (2)