Intraoperative real-time FA using ICG can assess perfusion, and thereby enables precise delineation of the ideal site for anastomosis and assessment of final anastomotic vitality. However, no quantitative threshold of the fluorescence signal is…
ID
Bron
Verkorte titel
Aandoening
Esophageal cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcomes are various quantitative parameters of FA, and to relate those parameters to surgical morbidity. Quantitative parameters include time to fluorescence in target or surrounding tissue.
Achtergrond van het onderzoek
Anastomotic complicaties after esophagectomy with continuity restoration are associated with a high mortality. Among the risk factors that influence anastomotic integrity, poor perfusion is a surgically modifiable factor. Intraoperative real-time fluorescence angiography (FA) using indocyanine green (ICG) can assess perfusion, and thereby enables precise delineation of the ideal site for anastomosis and assessment of final anastomotic vitality. Although management according to FA findings seems to lower anastomotic complications rates afer esophagectomy, complications still occur. Besides the multifactorial etiology of anastomotic complications, an explanation might be that no fluorescent threshold is known for complications.
In this monocenter prospective explorative study (IDEAL phase 2S study), we aim to evaluate time to fluorescent enhancement as a quantitative fluorescent value, and to correlate the values with surgical morbidity, including anastomotic leakage, graft necrosis and anastomotic strictures.
Doel van het onderzoek
Intraoperative real-time FA using ICG can assess perfusion, and thereby enables precise delineation of the ideal site for anastomosis and assessment of final anastomotic vitality. However, no quantitative threshold of the fluorescence signal is known for adequate perfusion. Time dependent change of the fluorescent signal seems a promising method for objective analysis of tissue perfusion. The hypothesis is that a quantitative threshold for this time dependent change can be identified to predict surgical morbidity.
Onderzoeksopzet
Surgery and follow-up
Onderzoeksproduct en/of interventie
Intraoperative FA is performed after intravenous ICG injection (0.05mg/kg/bolus). Time to first fluorescent enhancement is assessed using a digital clock and will be noted in a case-report form.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age of 18 years and older;
- Undergoing esophagectomy with gastric conduit reconstruction;
- Undergoing esophagectomy with continuity restoration, graft other than gastric conduit;
- Intraoperative FA to assess perfusion of graft and anastomosis;
- No objection for use of data.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Allergy to ICG, iodide or sodium iodide;
- Hyperthyroidism or benign thyroid tumor;
- Thyroid examination using radioactive iodide <1 week;
- Breast-feeding;
- Objection for use of data.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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