Clinical trial NCT05153954: Quantitative ICG Fluorescence Angiography in Colorectal Surgery
Official title: Quantitative ICG Fluorescence Angiography in Colorectal Surgery (QUANTICO): a Protocol for a Prospective, Standardized, Observational, Surgeon-blinded Multi-center Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Anastomotic Leak
Keywords: indocyanine green
colon cancer
primary anastomosis
anastomotic perfusion
anastomotic leak
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Perfusion Tech Aps
First posted: 2021-12-10
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative anastomotic complications
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants with complications according to Clavien-Dindo Classification
timeFrame: 90 days
measure: Number of participants with anastomotic leakage rate, severity (grade A-C)
timeFrame: 90 days
measure: Number of participants with postoperative bleeding
timeFrame: 10 days
measure: Number of participants with postoperative paralytic ileus
timeFrame: 90 days
measure: Number of participants with wound dehiscence
timeFrame: 1 month
measure: Comprehensive complications index
timeFrame: 90 days
measure: Duration of surgery
timeFrame: 1 day
measure: Reoperation rate
timeFrame: 1 month
measure: Hospital readmission
timeFrame: 1 month
measure: Length of hospital stay
timeFrame: 1 month
measure: QT interval variability
timeFrame: 2 days
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Department of Surgery, Zealand University Hospital
state: Region Zealand
city: Herlev
country: Denmark
facility: Department of Surgery, Herlev Hospital
Study officials:
affiliation: Department of Surgery, Zealand University Hospital
name: Ismail Gögenur, DMSc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Herlev Hospital
name: Niclas Dohrn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Herlev Hospital
name: Mads Falk Klein, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: