Morphologic Study of the Intersegmental Plane After Fully Thoracoscopic Segmentectomy
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Paris, Frankrig, 75014
- Rekruttering
- Institut Mutualiste Montsouris
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Kontakt:
- Isabelle Sauret
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: radiological evaluation
to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy
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injected CT scan at 3 or 6 months after segmentectomy VATS
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The measure of the remaining segments after stapling the intersegmental plane by injected CT scan
Tidsramme: 3 or 6 months after surgery
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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:
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3 or 6 months after surgery
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- THO-2016-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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