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

Instituto Mexicano del Seguro Social

Status: Enrolling

Conditions: Bariatric Surgery; Obesity

Treatments: Diagnostic Test: Indocyanine Green Angiogram

Study type: Interventional

Funder types: Other

Identifiers

NCT07000539

CEI-001-2025042

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 3 patient groups

indocyanine green (5 mg)

Active Comparator group

Description:

Participants in this arm will receive a single 5 mg intravenous dose of indocyanine green (ICG) during surgery, diluted in 10 mL of sterile saline, followed by a 20 mL saline flush. ICG angiography will be performed using a near-infrared (NIR) fluorescence imaging system (Stryker® 1688 4K laparoscopic camera or da Vinci Xi Firefly®). Imaging will begin immediately before ICG administration and will include a minimal 120 seconds focused on the pouch or duodenal area and the anastomosis. The camera will be positioned at a fixed 5 cm distance and 30° angle. All other surgical procedures will be conducted according to standard of care.

Treatment:

Diagnostic Test: Indocyanine Green Angiogram

indocyanine green (7.5 mg)

Active Comparator group

Description:

Participants in this arm will receive a single 7.5 mg intravenous dose of indocyanine green (ICG) during surgery, diluted in 10 mL of sterile saline, followed by a 20 mL saline flush. ICG angiography will be performed using a near-infrared (NIR) fluorescence imaging system (Stryker® 1688 4K laparoscopic camera or da Vinci Xi Firefly®). Imaging will begin immediately before ICG administration and will include a minimal 120 seconds focused on the pouch or duodenal area and the anastomosis. The camera will be positioned at a fixed 5 cm distance and 30° angle. All other surgical procedures will be conducted according to standard of care.

Treatment:

Diagnostic Test: Indocyanine Green Angiogram

indocyanine green (10 mg)

Active Comparator group

Description:

Participants in this arm will receive a single 10 mg intravenous dose of indocyanine green (ICG) during surgery, diluted in 10 mL of sterile saline, followed by a 20 mL saline flush. ICG angiography will be performed using a near-infrared (NIR) fluorescence imaging system (Stryker® 1688 4K laparoscopic camera or da Vinci Xi Firefly®). Imaging will begin immediately before ICG administration and will include a minimal 120 seconds focused on the pouch or duodenal area and the anastomosis. The camera will be positioned at a fixed 5 cm distance and 30° angle. All other surgical procedures will be conducted according to standard of care.

Treatment:

Diagnostic Test: Indocyanine Green Angiogram