Indocyanine Green Fluorescence Angiography (ICG-FA) in Revisional Bariatric Surgery
Prospective Single-center Diagnostic Parallel-group Study to Determine the Minimal Dose of Indocyanine Green to Observe Vascular Perfussion in Revisional Bariatric Surgery.
Instituto Mexicano del Seguro Social
108 participants
May 6, 2025
INTERVENTIONAL
Conditions
Summary
This study will compare different doses of a green fluorescent product that is administered during weight loss surgery in order to observe where blood vessels are located. There is uncertainty around the optimal dose of this product for patients with obesity, so this study will aim to study if the dose in the minimal range recommended by international guidelines is sufficient for most patients or if higher doses are needed with increasing body mass index.
Eligibility
Inclusion Criteria2
- Diagnosis of obesity with a BMI ≥ 30 kg/m²
- Scheduled for revisional bariatric surgery
Exclusion Criteria6
- Allergy to iodides.
- Anticoagulation with products containing sodium bisulfite (due to the risk of ICG-FA inactivation).
- Use of radioactive iodine studies within the past 7 days.
- Pregnant, breastfeeding, or planning to become pregnant within the next year (due to unknown teratogenic or fertility effects of ICG-FA).
- History of liver disease or laboratory findings suggestive of moderate to severe hepatic disease: total bilirubin \>1.5 times the upper limit of normal (ULN), or any elevation of aspartate aminotransferase (AST) above ULN.
- Participants who withdraw their consent to participate in the study (elimination criterion).
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Interventions
Three different doses of indocyanin green will be compared (5 mg, 7.5 mg, and 10 mg). These doses are within the range of currently recommended doses by the International Society for Fluorescence Guided Surgery (ISFGS) for bariatric surgery.
Locations(1)
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NCT07000539