Quantitative ICG Fluorescence Angiography in Colorectal Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer, Anastomotic Leak

Intervention / Treatment
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* Other: Quantitative Indocyanine Green Fluorescence Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Capable of giving informed consent ASA Classification: status I-III Planned for PME or TME with minimally invasive approach and primary anastomosis Strong suspicion of or biopsy-verified sigmoid or rectal cancer Stage I-IV cancer Exclusion Criteria: Known allergy to ICG or iodine Emergency procedure Pregnancy or if the patient is currently nursing Surgeons decide to do unblinded quantitative or qualitative ICG-FA

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal cancer patients<br>Patients who can be treated with either PME or TME and receive a primary anastomosis during surgery. | Other: Quantitative Indocyanine Green Fluorescence Angiography<br>* Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative anastomotic complications | combined rate of all anastomotic complications | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with complications according to Clavien-Dindo Classification |  | 90 days | 
| Number of participants with anastomotic leakage rate, severity (grade A-C) |  | 90 days | 
| Number of participants with postoperative bleeding |  | 10 days | 
| Number of participants with postoperative paralytic ileus | obstipation and intolerance of oral intake due to nonmechanical factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract following abdominal surgery | 90 days | 
| Number of participants with wound dehiscence | surgical complication in which a wound ruptures along a surgical incision | 1 month | 
| Comprehensive complications index |  | 90 days | 
| Duration of surgery |  | 1 day | 
| Reoperation rate |  | 1 month | 
| Hospital readmission | Number of patients had have to be readmitted to the hospital due to postoperative complications | 1 month | 
| Length of hospital stay |  | 1 month | 
| QT interval variability | Continuous ECG-monitoring intraoperatively and postoperatively | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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indocyanine green, colon cancer, primary anastomosis, anastomotic perfusion, anastomotic leak