Quantitative ICG Fluorescence Angiography in Colorectal Surgery
NCT ID: NCT05153954
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
114 participants
OBSERVATIONAL
2021-08-31
2024-11-28
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Colorectal cancer patients
Patients who can be treated with either PME or TME and receive a primary anastomosis during surgery.
Quantitative Indocyanine Green Fluorescence Angiography
Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis
Interventions
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Quantitative Indocyanine Green Fluorescence Angiography
Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis
Eligibility Criteria
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Inclusion Criteria
* 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
* Emergency procedure
* Pregnancy or if the patient is currently nursing
* Surgeons decide to do unblinded quantitative or qualitative ICG-FA
18 Years
ALL
No
Sponsors
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Perfusion Tech Aps
UNKNOWN
Zealand University Hospital
OTHER
Responsible Party
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Carolin Oppermann
Medical Doctor, PhD student
Principal Investigators
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Ismail Gögenur, DMSc, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Zealand University Hospital
Niclas Dohrn, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Herlev Hospital
Mads Falk Klein, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Herlev Hospital
Locations
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Department of Surgery, Zealand University Hospital
Køge, Region Sjælland, Denmark
Department of Surgery, Herlev Hospital
Herlev, , Denmark
Countries
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Other Identifiers
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REG-046-2021
Identifier Type: -
Identifier Source: org_study_id