Colorectal CancerICG-COLORALNCT03602677
Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
A study testing ICG fluorescence imaging in people with Colorectal Cancer and Colorectal Neoplasms, run by Oulu University Hospital at 2 sites in Finland.
Trial summary
This is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms, Gastrointestinal Cancer
- What is being tested?
- ICG fluorescence imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,062 participants
- Where
- 2 sitesFinland
- Study dates
- 24 Sep 2018to 1 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- All consenting patients in the catchment area of participating hospitals who undergo elective colorectal surgery with planned primary anastomosis are eligible for this study.
- Of rectal cancer patients only those with pathology in the proximal third will be included in the study (defined by area proximal from peritoneal fold).
Who cannot join
- Emergent patients
- Patients with proven diverticular abscess and colonic fistulas are excluded
- Patients with planned open surgery are excluded.
Trial locations and contacts
2 sites in 1 country.
Finland2 sites, 2 recruiting
- Recruiting
Central Finland Central Hospital
Jyväskylä
Olli Helminen, MD, PhD, olli.helminen@oulu.fi
- Recruiting
Päijät Häme Central Hospital
Lahti
Jyrki Kössi, MD, PhD, jyrki.kossi@phhyky.fi
About this study
This is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Gastrointestinal Cancer, Gastrointestinal Neoplasms, Diverticulosis, Colonic, Gastrointestinal Disease
- Being tested
- ICG fluorescence imaging
- Keywords
- Colorectal surgery, Anastomosis, Anastomosis leak, Fluorescence imaging
- Medical subject headings
- Colorectal Neoplasms, Gastrointestinal Neoplasms, Diverticulosis, Colonic, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG fluorescence imagingDevice
The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| ICG fluorescence imaging | Experimental | Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging. Receives: Device: ICG fluorescence imaging |
| Standard procedure | No intervention | Standard colorectal surgery and anastomosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomosis leakage rate
Measured: 0 to 90 days
Secondary outcomes (12)
Severity of anastomosis leakage
Grade A-C according to International Study Group of Rectal Cancer
Measured: 0 to 90 days
Timing of anastomosis leakage
Days
Measured: 0 to 90 days
Deep surgical site infections
Yes/no
Measured: 0 to 90 days
Hospital readmission rate
Measured: 0 to 90 days
Reoperation rate
Measured: 0 to 90 days
30- and 90-day complications according to Clavien-Dindo Classification
Clavien-Dindo Score from Grade 0 (no complications) to Grade V (Death of a patient). Five grades and additionally Grade III and IV will be divided to a and b.
Measured: 0 to 90 days
Operation time
Time from the start of the operation until the surgeon has ended the operation
Measured: 0-600 minutes
Length of hospital stay
Day of the operation is considered the day 0
Measured: 0-365 days
30- and 90-day mortality
Measured: 0 to 90 days
Time to first bowel movement
Postoperative day when the first bowel movement occurs
Measured: 0-30 days
Time to first flatus
Postoperative day when the first flatus occurs
Measured: 0-30 days
Hospital costs
Measured: 0 to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start24 Sep 2018
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,062 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu, Central Finland Hospital District, Tampere University Hospital, Turku University Hospital, Hospital District of Helsinki and Uusimaa, Päijänne Tavastia Central Hospital, Seinäjoki Central Hospital, Seinäjoki, Finland
- Responsible party
- Principal investigator, Olli Helminen, Oulu University Hospital
- Investigators
- Jyrki Kössi, MD, PhD, Principal investigator, Päijänne Tavastia Central HospitalOlli Helminen, MD, PhD, Principal investigator, Oulu University Hospital, Oulu, Finland and Central Finland Central Hospital, Jyväskylä, FinlandHeikki Huhta, MD, PhD, Principal investigator, Oulu University HospitalJuha Rinne, MD, Principal investigator, Päijänne Tavastia Central HospitalMatti Kairaluoma, MD, PhD, Principal investigator, Central Finland Central Hospital, Jyväskylä, FinlandTero Rautio, MD, PhD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602677
- Sponsor's protocol ID
- ICG-COLORAL
- Acronym
- ICG-COLORAL
- Status last verified
- Mar 2023
- First submitted
- 25 Mar 2018
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rinne JKA, Huhta H, Pinta T, Turunen A, Mattila A, Tahkola K, Helminen O, Ohtonen P, Rautio T, Kossi J. Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage: A Randomized Clinical Trial. JAMA Surg. 2025 May 1;160(5):486-493. doi: 10.1001/jamasurg.2025.0006.
PubMed 40042831
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
- ClinicalTrials.gov ID
- NCT03602677
- Acronym / sponsor ID
- ICG-COLORAL / ICG-COLORAL
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Gastrointestinal Cancer, Gastrointestinal Neoplasms, Diverticulosis, Colonic, Gastrointestinal Disease
- Keywords
- Colorectal surgery, Anastomosis, Anastomosis leak, Fluorescence imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,062 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- University of Oulu, Central Finland Hospital District, Tampere University Hospital, Turku University Hospital, Hospital District of Helsinki and Uusimaa, Päijänne Tavastia Central Hospital, Seinäjoki Central Hospital, Seinäjoki, Finland
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 27 Jul 2018 (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.
This is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICG fluorescence imaging | Experimental | Device: ICG fluorescence imagingColorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging. |
| Standard procedure | No intervention | –Standard colorectal surgery and anastomosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All consenting patients in the catchment area of participating hospitals who undergo elective colorectal surgery with planned primary anastomosis are eligible for this study.
- Of rectal cancer patients only those with pathology in the proximal third will be included in the study (defined by area proximal from peritoneal fold).
Key exclusion criteria (3 listed)
- Emergent patients
- Patients with proven diverticular abscess and colonic fistulas are excluded
- Patients with planned open surgery are excluded.
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 |
|---|---|---|
| ICG fluorescence imagingThe use of indocyanine green fluorescence imaging as an addition to standard surgical procedure. | Device | ICG fluorescence imaging |
Primary outcome
Anastomosis leakage rate
Time frame: 0 to 90 days
12 secondary outcomes
Severity of anastomosis leakage
Time frame: 0 to 90 days
Timing of anastomosis leakage
Time frame: 0 to 90 days
Deep surgical site infections
Time frame: 0 to 90 days
Hospital readmission rate
Time frame: 0 to 90 days
Reoperation rate
Time frame: 0 to 90 days
30- and 90-day complications according to Clavien-Dindo Classification
Time frame: 0 to 90 days
Operation time
Time frame: 0-600 minutes
Length of hospital stay
Time frame: 0-365 days
30- and 90-day mortality
Time frame: 0 to 90 days
Time to first bowel movement
Time frame: 0-30 days
Time to first flatus
Time frame: 0-30 days
Hospital costs
Time frame: 0 to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Derived from this study: PubMed 40042831Rinne JKA, Huhta H, Pinta T, Turunen A, Mattila A, Tahkola K, Helminen O, Ohtonen P, Rautio T, Kossi J. Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage: A Randomized Clinical Trial. JAMA Surg. 2025 May 1;160(5):486-493. doi: 10.1001/jamasurg.2025.0006.
- 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.
Jyrki Kössi, MD, PhD principal investigator
Päijänne Tavastia Central Hospital
Olli Helminen, MD, PhD principal investigator
Oulu University Hospital, Oulu, Finland and Central Finland Central Hospital, Jyväskylä, Finland
Heikki Huhta, MD, PhD principal investigator
Oulu University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG fluorescence imaging in people with Colorectal Cancer and Colorectal Neoplasms, run by Oulu University Hospital at 2 sites in Finland.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Mar 2023. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jyrki Kössi, MD, PhD (+358381911, jyrki.kossi@phhyky.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomosis leakage rate (time frame: 0 to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03602677, which also lists 1 linked publication.
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 27 Mar 2023.