NCT05153954

Quantitative ICG Fluorescence Angiography in Colorectal Surgery

Quantitative ICG Fluorescence Angiography in Colorectal Surgery (QUANTICO): a Protocol for a Prospective, Standardized, Observational, Surgeon-blinded Multi-center Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 114 (actual)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fluorescence angiography with indocyanine green (ICG-FA) has gained increased popularity in colorectal surgery to check perfusion to the newly-formed anastomotic area and decrease the rate of postoperative anastomotic leakage. While qualitative ICG assessment has the advantage to be used instantly during the operative procedure, it does bear drawbacks (subjective assessment, dependent on factors like camera distance, ICG dose and white-light contamination). The alternative is quantitative ICG assessment, which is performed by evaluating the time-intensity curve of the ICG-FA with an external analyzing software. The procedure is showing promising results, but the methodology is still reported very heterogeneously. This study is a multi-center, prospective, standardized, surgeon-blinded observational trial. The key aspect of this study is the non-interventional design with blinding of both the qualitative and quantitative results from the ICG perfusion measurement, providing no chance of influencing the course of the operation. Assessment of perfusion will be performed postoperatively blinded to the outcome. Assessment of the pre-anastomotic area is intraoperatively performed by an image analysis software that then calculates a perfusion score based on an algorithm integrating relevant perfusion metrics. The primary outcome is the combined rate of early and late anastomotic complications within 90 days postoperatively.

Conditions

• Colorectal Cancer
• Anastomotic Leak

Interventions

Type	Name	Description
OTHER	Quantitative Indocyanine Green Fluorescence Angiography	Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis

Timeline

• Start date: 2021-08-31
• Primary completion: 2024-08-31
• Completion: 2024-11-28
• First posted: 2021-12-10
• Last updated: 2024-12-03

Locations

2 sites across 1 country: Denmark