Fluorescent angiography using indocyanine green during esophagectomy with continuity restoration to prevent anastomotic complications

Quantitative fluorescent angiography using indocyanine green during esophagectomy with with continuity restoration to prevent anastomotic complications

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24815

Enrollment

Registered

2020-04-14

Start date

2018-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

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.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactMaxime Slooter

Amsterdam UMC, location AMC

m.d.slooter@amsterdamumc.nl0031 (0)20 566 2771

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)