Colorectal CancerQUANTICONCT05153954
Quantitative ICG Fluorescence Angiography in Colorectal Surgery
An observational study of Colorectal Cancer and Anastomotic Leak, run by Zealand University Hospital at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Anastomotic Leak
- What is being tested?
- Quantitative Indocyanine Green Fluorescence Angiography
- Type of treatment
- Pill or oral medicine
- How many people
- 114 participants
- Where
- 2 sitesDenmark
- Study dates
- 31 Aug 2021to 28 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Surgery, Herlev Hospital
Herlev, 2730
Department of Surgery, Zealand University Hospital
Køge, Region Sjælland, 4200
About this study
Official title: 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).
Read more
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
- Being tested
- Quantitative Indocyanine Green Fluorescence Angiography
- Keywords
- indocyanine green, colon cancer, primary anastomosis, anastomotic perfusion, anastomotic leak
- Medical subject headings
- Colorectal Neoplasms, Anastomotic Leak, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Indocyanine Green Fluorescence AngiographyOther
Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer patients | Patients who can be treated with either PME or TME and receive a primary anastomosis during surgery. Receives: Other: Quantitative Indocyanine Green Fluorescence Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative anastomotic complications
combined rate of all anastomotic complications
Measured: 3 months
Secondary outcomes (11)
Number of participants with complications according to Clavien-Dindo Classification
Measured: 90 days
Number of participants with anastomotic leakage rate, severity (grade A-C)
Measured: 90 days
Number of participants with postoperative bleeding
Measured: 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
Measured: 90 days
Number of participants with wound dehiscence
surgical complication in which a wound ruptures along a surgical incision
Measured: 1 month
Comprehensive complications index
Measured: 90 days
Duration of surgery
Measured: 1 day
Reoperation rate
Measured: 1 month
Hospital readmission
Number of patients had have to be readmitted to the hospital due to postoperative complications
Measured: 1 month
Length of hospital stay
Measured: 1 month
QT interval variability
Continuous ECG-monitoring intraoperatively and postoperatively
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start31 Aug 2021
- Primary completion31 Aug 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Perfusion Tech Aps
- Responsible party
- Principal investigator, Carolin Oppermann, Zealand University Hospital
- Investigators
- Ismail Gögenur, DMSc, MD, Principal investigator, Department of Surgery, Zealand University HospitalNiclas Dohrn, MD, Principal investigator, Department of Surgery, Herlev HospitalMads Falk Klein, PhD, MD, Principal investigator, Department of Surgery, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153954
- Sponsor's protocol ID
- REG-046-2021
- Acronym
- QUANTICO
- Status last verified
- Nov 2024
- First submitted
- 24 Sep 2021
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative ICG Fluorescence Angiography in Colorectal Surgery (QUANTICO): a Protocol for a Prospective, Standardized, Observational, Surgeon-blinded Multi-center Trial
- ClinicalTrials.gov ID
- NCT05153954
- Acronym / sponsor ID
- QUANTICO / REG-046-2021
- Conditions
- Colorectal Cancer, Anastomotic Leak
- Keywords
- indocyanine green, colon cancer, primary anastomosis, anastomotic perfusion, anastomotic leak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Perfusion Tech Aps
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer patients | – | Other: Quantitative Indocyanine Green Fluorescence AngiographyPatients who can be treated with either PME or TME and receive a primary anastomosis during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative Indocyanine Green Fluorescence AngiographyQuantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis | Other | Colorectal cancer patients |
Primary outcome
Postoperative anastomotic complications
Time frame: 3 months
combined rate of all anastomotic complications
11 secondary outcomes
Number of participants with complications according to Clavien-Dindo Classification
Time frame: 90 days
Number of participants with anastomotic leakage rate, severity (grade A-C)
Time frame: 90 days
Number of participants with postoperative bleeding
Time frame: 10 days
Number of participants with postoperative paralytic ileus
Time frame: 90 days
Number of participants with wound dehiscence
Time frame: 1 month
Comprehensive complications index
Time frame: 90 days
Duration of surgery
Time frame: 1 day
Reoperation rate
Time frame: 1 month
Hospital readmission
Time frame: 1 month
Length of hospital stay
Time frame: 1 month
QT interval variability
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Gögenur, DMSc, MD principal investigator
Department of Surgery, Zealand University Hospital
Niclas Dohrn, MD principal investigator
Department of Surgery, Herlev Hospital
Mads Falk Klein, PhD, MD principal investigator
Department of Surgery, Herlev Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Anastomotic Leak, run by Zealand University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative anastomotic complications (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024; AzTrials last refreshed its copy on 2 Nov 2026.