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

Not Applicable

Recruiting

• Conditions: Obesity; Bariatric Surgery

• Registration Number: NCT07000539
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-06
• Study First Submitted: 2025-05-24
• Study First Submitted QC: 2025-05-24
• Last Update Submitted: 2025-05-24
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Fluorescence Detection	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 Outcome Measures

Name	Time	Method
Regional Tissue Perfusion by Anatomical Zone	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.
Adverse Events Related to ICG Use	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.
Postoperative Complications	30 days postoperatively	Incidence of postoperative complications within 30 days, including anastomotic leak, infection, bleeding, reoperation, or readmission.
Change in Surgical Strategy Based on ICG-FA	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.

Trial Locations

Locations (1)

Centro Medico Bariatrico; 🇲🇽 Tijuana, Baja California, Mexico