Quantitative ICG Fluorescence Angiography in Colorectal Surgery

NCT05153954 | Completed DMC

• 1 other identifier: REG-046-2021
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer; Anastomotic Leak

Keywords

indocyanine green; colon cancer; primary anastomosis; anastomotic perfusion; anastomotic leak

Outcome Measures

Primary Outcomes (1)

• Postoperative anastomotic complications

  combined rate of all anastomotic complications

  3 months

Secondary Outcomes (11)

• 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

  90 days

• Number of participants with wound dehiscence

  1 month

Study Arms (1)

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

Interventions

Quantitative Indocyanine Green Fluorescence Angiography OTHER

Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis

Colorectal cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead
• Perfusion Tech Aps: collaborator

Study Sites (2)

Department of Surgery, Zealand University Hospital

Køge, Region Sjælland, 4200, Denmark

Location

Department of Surgery, Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Anastomotic Leak; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD student

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: December 10, 2021
• Study Start: August 31, 2021
• Primary Completion: August 31, 2024
• Study Completion: November 28, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)