Indocyanine Green Fluorescence Angiography (ICG-FA) in Revisional Bariatric Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indocyanine Green Angiogram.
- Who it may be relevant to
- Registry conditions: Obesity, Bariatric Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Single-center Diagnostic Parallel-group Study to Determine the Minimal Dose of Indocyanine Green to Observe Vascular Perfussion in Revisional Bariatric Surgery.
Overview
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.
Interventions
- Diagnostic test Indocyanine Green Angiogram
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.
Primary outcome measures
- Time to Fluorescence Detection [Time frame: Intraoperative (within 5 minutes post-injection)]
Secondary outcome measures (4)
- Regional Tissue Perfusion by Anatomical Zone [Time frame: Intraoperative]
- Change in Surgical Strategy Based on ICG-FA [Time frame: Intraoperative]
- Adverse Events Related to ICG Use [Time frame: Within 48 hours postoperatively]
- Postoperative Complications [Time frame: 30 days postoperatively]
Eligibility criteria
Inclusion criteria
- Diagnosis of obesity with a BMI ≥ 30 kg/m²
- Scheduled for revisional bariatric surgery
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Diagnostic
Study locations
Mexico · 1 center
- Centro Medico Bariatrico — Tijuana
Identifiers
NCT: NCT07000539 · CEI-001-2025042