No registrations found.
ID
Source
Brief title
Health condition
Esophageal cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Secondary outcomes include surgical morbidity, other FA details, and hemodynamic parameters. Surgical outcomes include anastomotic leakage, graft necrosis and anastomotic strictures. FA details include change in management and additional surgical time.
Background summary
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.
Study objective
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.
Study design
Surgery and follow-up
Intervention
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.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8527 |
| Other | METC AMC : W19_145 (outside the realm of the Dutch WMO law) |