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

Browse trials for

• Obesity 6,258
• Intraoperative Complications 77
• Postoperative Complications 1,231

Keywords

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

Study arms

• Active comparator
  indocyanine green (5 mg)

  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

• Active comparator
  indocyanine green (7.5 mg)

  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

• Active comparator
  indocyanine green (10 mg)

  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

• Diagnostic testIndocyanine Green Angiogram

  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

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

Individual participant data

Plan to share: Yes — Anonymized individual participant data will be deposited and made available through an open acess data repository (i.e., Harvard Dataverse). Any potentially sensitive patient-identifying data will either not be released or will undergo minimization and aggregation/abstraction procedures to reduce participant identification risk. Informed consent forms will indicate that a minimal risk of re-identification cannot be excluded despite all these participant data protection methods, in compliance with current IPD sharing recommendations.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code