Quantitative ICG Fluorescence Angiography in Colorectal Surgery

Colorectal Cancer Clinical Trial

— QUANTICO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05153954
• Other study ID #: REG-046-2021
• Status: Recruiting
• Start date: August 31, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2023
• Source: Zealand University Hospital
• Contact: Carolin Oppermann, MD
• Phone: 004952115957
• Email: caopp[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Colorectal Cancer

Intervention

Other:
• Quantitative Indocyanine Green Fluorescence Angiography
Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis

Locations

Country	Name	City	State
Denmark	Department of Surgery, Herlev Hospital	Herlev
Denmark	Department of Surgery, Zealand University Hospital	Køge	Region Zealand

Sponsors (2)

Lead Sponsor	Collaborator
Zealand University Hospital	Perfusion Tech Aps

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative anastomotic complications	combined rate of all anastomotic complications	3 months
Secondary	Number of participants with complications according to Clavien-Dindo Classification		90 days
Secondary	Number of participants with anastomotic leakage rate, severity (grade A-C)		90 days
Secondary	Number of participants with postoperative bleeding		10 days
Secondary	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
Secondary	Number of participants with wound dehiscence	surgical complication in which a wound ruptures along a surgical incision	1 month
Secondary	Comprehensive complications index		90 days
Secondary	Duration of surgery		1 day
Secondary	Reoperation rate		1 month
Secondary	Hospital readmission	Number of patients had have to be readmitted to the hospital due to postoperative complications	1 month
Secondary	Length of hospital stay		1 month
Secondary	QT interval variability	Continuous ECG-monitoring intraoperatively and postoperatively	2 days