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NCT Number: NCT07000539

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

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.

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Key information

Conditions

Obesity Bariatric Surgery Body Weight Intraoperative Complications Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Medico Bariatrico

Tijuana, Estado de Baja California, 22046, Mexico

Location status: Recruiting

Location contact

Manuel A Guerrero Gutierrez, MD

CONTACT

[email protected]

+52 664 274 6273

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: ICG-FA, Indocyanine green fluorescence angiography

Primary outcomes

  1. Time to Fluorescence Detection

    Time frame: Intraoperative (within 5 minutes post-injection)

    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.

Secondary outcomes

  1. Regional Tissue Perfusion by Anatomical Zone

    Time frame: Intraoperative

    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.

  2. Change in Surgical Strategy Based on ICG-FA

    Time frame: Intraoperative

    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.

  3. Adverse Events Related to ICG Use

    Time frame: Within 48 hours postoperatively

    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.

  4. Postoperative Complications

    Time frame: 30 days postoperatively

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

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Collaborators

  • Bariatric Medical Center

Registry information

Official study title

Prospective Single-center Diagnostic Parallel-group Study to Determine the Minimal Dose of Indocyanine Green to Observe Vascular Perfussion in Revisional Bariatric Surgery.

Acronym: BariGreen

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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