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

NCT07000539 | Recruiting

• 1 other identifier: CEI-001-2025042
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Bariatric Surgery

Keywords

bariatric surgery; indocyanine green; vascular; weight loss surgery; Intraoperative Complications; Postoperative Complications

Outcome Measures

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.

  Intraoperative (within 5 minutes post-injection)

Secondary Outcomes (4)

• Regional Tissue Perfusion by Anatomical Zone

  Intraoperative

• Change in Surgical Strategy Based on ICG-FA

  Intraoperative

• Adverse Events Related to ICG Use

  Within 48 hours postoperatively

• Postoperative Complications

  30 days postoperatively

Study Arms (3)

indocyanine green (5 mg)

ACTIVE COMPARATOR

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.

Diagnostic Test: Indocyanine Green Angiogram

indocyanine green (7.5 mg)

ACTIVE COMPARATOR

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.

Diagnostic Test: Indocyanine Green Angiogram

indocyanine green (10 mg)

ACTIVE COMPARATOR

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.

Diagnostic Test: Indocyanine Green Angiogram

Interventions

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.

Also known as: ICG-FA, Indocyanine green fluorescence angiography

indocyanine green (10 mg); indocyanine green (5 mg); indocyanine green (7.5 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of obesity with a BMI ≥ 30 kg/m²
• Scheduled for revisional bariatric surgery

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• Bariatric Medical Center: collaborator

Study Sites (1)

Centro Medico Bariatrico

Tijuana, Estado de Baja California, 22046, Mexico

RECRUITING

MeSH Terms

Conditions

Obesity; Intraoperative Complications; Postoperative Complications

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group assignment is centrally managed. Participants are blinded under anesthesia, with no awareness of group assignment. The anesthesiologist knows the dose but is blinded to outcomes and conceals the dose from surgeons. Data collectors and laboratory technicians are not informed of group assignment or study purpose. Adjudicators of outcomes, not involved in surgery, will assess postoperative videos blinded to patient characteristics and knowing only the timing of drug administration. Data analysts and the data safety monitoring committee use coded identifiers to remain blinded to group assignments. The manuscript's results will be written blinded, after which codes will be replaced for actual doses to interpret and discuss the findings.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 3, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting information will be made available with the final original research article, which will be made available as a preprint within a maximum 1-year term after the study conclusion date. This report will be subsequently sent for publication in a peer-reviewed journal. Other pre-specified outcomes may be reported in separate publication after the main research article, reason why the indicated time frame does not apply for such outcomes. There i
• Access Criteria: No data and supporting information access restrictions are anticipated, as these will be deposited in open access repositories (i.e., Harvard Dataverse, Open Science Framework, Zenodo).

Locations

ME (1)