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Indocyanine Green Fluorescence Angiography (ICG-FA) in Revisional Bariatric Surgery

ConditionsObesityBariatric Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Mexicano del Seguro Social

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of obesity with a BMI ≥ 30 kg/m²

Scheduled for revisional bariatric surgery

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Indocyanine Green Angiogram

    Diagnostic test

    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.

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: indocyanine green (5 mg)Active comparator 1 intervention
Group B: indocyanine green (7.5 mg)Active comparator 1 intervention
Group C: indocyanine green (10 mg)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to Fluorescence Detection

Time (in seconds) from intravenous injection of indocyanine green (ICG) to the first visual detection of fluorescence in the surgical field, as captured using near-infrared fluorescence imaging. Assessed at four time points (30s, 60s, 90s, 120s) post-injection. Timing will be standardized from injection to image capture. Time point of first visible fluorescence will be recorded by blinded assessors.

Time frame
Intraoperative (within 5 minutes post-injection)

Secondary outcomes

1

Regional Tissue Perfusion by Anatomical Zone

Fluorescence signal intensity and timing will be recorded for predefined anatomical zones based on vascular supply in the gastric pouch and duodenal stump. Zones are classified as Zone 1 (proximal/cardial), Zone 2 (mid/corporal), Zone 3 (distal/anastomotic) for the pouch, and Zone 1 (pyloric transition), Zone 2 (suprapancreatic duodenum), and Zone 3 (distal duodenum) for the duodenum. Signal quality will be scored (e.g., adequate/inadequate) and recorded for each zone.

Time frame
Intraoperative
2

Change in Surgical Strategy Based on ICG-FA

Proportion of cases in which surgical plans were modified intraoperatively (e.g., change in site of anastomosis, reinforcement, or tissue resection) based on ICG perfusion findings.

Time frame
Intraoperative
3

Adverse Events Related to ICG Use

Number and type of adverse events related to ICG administration, including allergic reactions (e.g., rash, anaphylaxis) or abnormal elevations in liver enzymes (AST, ALT, bilirubin) postoperatively.

Time frame
Within 48 hours postoperatively
4

Postoperative Complications

Incidence of postoperative complications within 30 days, including anastomotic leak, infection, bleeding, reoperation, or readmission.

Time frame
30 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto Mexicano del Seguro Social

Lead sponsor

Bariatric Medical Center

Collaborator

Source ClinicalTrials.gov
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