Quantitative ICG Fluorescence Angiography in Colorectal Surgery (QUANTICO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Anastomotic Leak
• Intervention / Treatment: Other: Quantitative Indocyanine Green Fluorescence Angiography

• Study Type: Observational
• Enrollment (Anticipated): 115

Contacts and Locations

• Study Contact: Name: Carolin Oppermann, MD; Phone Number: 004952115957; Email: caopp@regionsjaelland.dk
• Study Contact Backup: Name: Niclas Dohrn, MD; Phone Number: 004521289777

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Not yet recruiting
    • Department of Surgery, Herlev Hospital
    • Contact: Niclas Dohrn, MD
  • Region Zealand
    • Køge, Region Zealand, Denmark, 4200
      • Recruiting
      • Department of Surgery, Zealand University Hospital
      • Contact: Carolin Oppermann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include 115 participants undergoing elective resection with PME or TME for rectal or rectosigmoid cancer through a minimally invasive approach.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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
Length of hospital stay		1 month
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
QT interval variability	Continuous ECG-monitoring intraoperatively and postoperatively	2 days

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: Perfusion Tech Aps
• Investigators: Principal Investigator: Ismail Gögenur, DMSc, MD, Department of Surgery, Zealand University Hospital; Principal Investigator: Niclas Dohrn, MD, Department of Surgery, Herlev Hospital; Principal Investigator: Mads Falk Klein, PhD, MD, Department of Surgery, Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: anastomotic leak; colon cancer; indocyanine green; primary anastomosis; anastomotic perfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: REG-046-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No