Bowel; Ischemic, AcuteFLAMESNCT06322862
FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery
A study testing Indocyanine green in people with Bowel; Ischemic, Acute, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in Denmark.
Trial summary
This is a prospective, multicentre, non-randomized cohort study using real-time intraoperative visualization of bowel perfusion by indocyanine green (ICG) in all-cause bowel ischemia. At intraoperative finding of bowel ischemia, the initial intraoperative plan is noted and resection margins marked with a steril pen. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel; Ischemic, Acute
- What is being tested?
- Indocyanine green
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesDenmark
- Study dates
- 5 Mar 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients >18 years of age
- Acute physiologic derangement and suspected of having bowel ischemia
- Intraoperative finding of all-cause bowel ischemia with subsequent acute physiologic derangement
Who cannot join
- Allergy toward; iodine, indocyanine green, or shellfish
- Liver insufficiency
- Thyrotoxicosis
- Pregnancy or lactation
- Permanently legally incompetent for any reason
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Department of Surgery, Bispebjerg Hospital
Bispebjerg
Peter Bonde, MD
- Recruiting
Department of Organ Surgery and Transplantation
Copenhagen, Capital Region, 2100
Sermed Ellebæk Nicolae, MD, +4535459666, sermed.ellebaek.nicolae@regionh.dk
Michael P Achiam, MD, DMSc, +45 3545 0441, michael.patrick.achiam.01@regionh.dk
- Recruiting
Department of Surgery, Herlev Hospital
Herlev
Jakob Burcharth, MD, PhD
- Recruiting
Department of Surgery, Nordsjællands Hospital
Hillerød
Mai-Britt Tolstrup, MD, PhD
- Recruiting
Department of Surgery, Hvidovre Hospital
Hvidovre
Morten Laksafoss Lauritsen, MD
About this study
Official title: Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery
This is a prospective, multicentre, non-randomized cohort study using real-time intraoperative visualization of bowel perfusion by indocyanine green (ICG) in all-cause bowel ischemia.
At intraoperative finding of bowel ischemia, the initial intraoperative plan is noted and resection margins marked with a steril pen. A fluorescence angiography will be performed and the surgeon will note whether the suspected ischemic bowel is perfused, whether there is a change in the resection margins in centimeters, and if the intraoperative plan has changed. If resection is indicated and the strategy of choice is an anastomosis, a renewed fluorescence angiography will be performed to assess anastomotic perfusion.
Read the detailed description
Fluorescence guided-surgery utilises the fluorescent property of a fluorophore, indocyanine green (ICG), injected intravenously to assess perfusion and viability of the bowel.
This study aims to evaluate the usability and feasibility of ICG to assess bowel viability in an emergency abdominal surgery setting where all-cause bowel ischemia is suspected and intraoperatively present. The investigators aim to evaluate whether ICG fluorescence angiography contributes as an intraoperative aid and changes the intraoperative strategy.
The investigators hypothesize that ICG is a safe and reliable aid in intraoperative decision-making regarding mesenteric ischemia. It may lead to an increasing number of one-step definitive procedures with vital resection margins, primary anastomosis and reducing stomas, and second-look procedures.
In this prospective, non-randomized cohort study bowel viability will be assessed using intraoperative real-time visualization by performing an ICG-fluorescence angiography when there is intraoperative finding of bowel ischemia.
Intraoperatively, ICG (Verdye, Diagnostic Green GmbH 25 mg vials) are dissolved with 5 ml sterile water obtaining a concentration of 5 mg/ml. 0,2mg/kg will be administered intravenously at one to two steps of perfusion assessment.
Initially, the surgeon notes the intended intraoperative plan before fluorescing and if resection is deemed necessary, the resection margins will be marked with a sterile pen.
The perfusion assessment with ICG is then performed and perfusion of the suspected ischemic bowel is noted, along with any change in intended resection margins and intraoperative plan. If an anastomosis is performed, a renewed perfusion assessment is performed. The perfusion assessment will be recorded.
Postoperatively, a subgroup of suitable perfusion assessment recordings will be subject to quantification software using software developed and validated by the investigators (q-ICG).
The trial follows regulations for research in emergency settings and a written and oral informed consent will be obtained from the participant or the participants next of kin and a trial guardian, postoperatively.
Intra- and postoperative clinical data will be collected, including choice of strategy, anastomotic leaks, 30- and 90- day complications, and mortality rates.
- Conditions
- Bowel; Ischemic, Acute
- Being tested
- Indocyanine green
- Keywords
- indocyanine green, perfusion assessment, acute care surgery
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenOther
Intraoperative perfusion assessment with ICG Fluorescence Angiography (ICG-FA) in standard approved doses
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | Not described Receives: Other: Indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of strategy
Change of intraoperative strategy due to ICG fluorescence angiography. Intraoperatively, a nurse will record the initial strategy, indication of resection in centimeters, before and after ICG angiography, and note whether there has been a change in strategy, and how.
Measured: Assessed at day 30 and 90 after surgery
Secondary outcomes (8)
Anastomosis
Number of anastomoses established in ICG-perfused bowel segments
Measured: Assessed at day 30 and 90 after surgery
Quantification using q-ICG
A posthoc perfusion quantification using q-ICG software
Measured: 30 months
Stomas
Number of cases where stoma was the preferred strategy
Measured: Assessed at day 30 and 90 after surgery
Second-look
Number of cases where second-look following bowel discontinuation, was the preferred strategy
Measured: Assessed at day 30 and 90 after surgery
Anastomotic leaks
Cases of anastomotic leaks postoperatively
Measured: Assessed at day 30 and 90 after surgery
Postoperative medical complications
Stratified by type and severity (Comprehensive Complication Index)
Measured: Assessed at day 30 and 90 after surgery
Postoperative surgical complications
Stratified by type and severity (Comprehensive Complication Index)
Measured: Assessed at day 30 and 90 after surgery
Mortality
30- and 90-day mortality rates
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start5 Mar 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel; Ischemic, AcuteStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Patrick Achiam, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Sermed Ellebæk Nicolae, MD, PhDstudent, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322862
- Sponsor's protocol ID
- H-23042430
- Acronym
- FLAMES
- Status last verified
- Nov 2024
- First submitted
- 8 Mar 2024
- Last updated
- 15 Nov 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 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery
- ClinicalTrials.gov ID
- NCT06322862
- Acronym / sponsor ID
- FLAMES / H-23042430
- Conditions
- Bowel; Ischemic, Acute
- Keywords
- indocyanine green, perfusion assessment, acute care surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 21 Mar 2024 (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 prospective, multicentre, non-randomized cohort study using real-time intraoperative visualization of bowel perfusion by indocyanine green (ICG) in all-cause bowel ischemia.
At intraoperative finding of bowel ischemia, the initial intraoperative plan is noted and resection margins marked with a steril pen. A fluorescence angiography will be performed and the surgeon will note whether the suspected ischemic bowel is perfused, whether there is a change in the resection margins in centimeters, and if the intraoperative plan has changed. If resection is indicated and the strategy of choice is an anastomosis, a renewed fluorescence angiography will be performed to assess anastomotic perfusion.
Detailed description
Fluorescence guided-surgery utilises the fluorescent property of a fluorophore, indocyanine green (ICG), injected intravenously to assess perfusion and viability of the bowel.
This study aims to evaluate the usability and feasibility of ICG to assess bowel viability in an emergency abdominal surgery setting where all-cause bowel ischemia is suspected and intraoperatively present. The investigators aim to evaluate whether ICG fluorescence angiography contributes as an intraoperative aid and changes the intraoperative strategy.
The investigators hypothesize that ICG is a safe and reliable aid in intraoperative decision-making regarding mesenteric ischemia. It may lead to an increasing number of one-step definitive procedures with vital resection margins, primary anastomosis and reducing stomas, and second-look procedures.
In this prospective, non-randomized cohort study bowel viability will be assessed using intraoperative real-time visualization by performing an ICG-fluorescence angiography when there is intraoperative finding of bowel ischemia.
Intraoperatively, ICG (Verdye, Diagnostic Green GmbH 25 mg vials) are dissolved with 5 ml sterile water obtaining a concentration of 5 mg/ml. 0,2mg/kg will be administered intravenously at one to two steps of perfusion assessment.
Initially, the surgeon notes the intended intraoperative plan before fluorescing and if resection is deemed necessary, the resection margins will be marked with a sterile pen.
The perfusion assessment with ICG is then performed and perfusion of the suspected ischemic bowel is noted, along with any change in intended resection margins and intraoperative plan. If an anastomosis is performed, a renewed perfusion assessment is performed. The perfusion assessment will be recorded.
Postoperatively, a subgroup of suitable perfusion assessment recordings will be subject to quantification software using software developed and validated by the investigators (q-ICG).
The trial follows regulations for research in emergency settings and a written and oral informed consent will be obtained from the participant or the participants next of kin and a trial guardian, postoperatively.
Intra- and postoperative clinical data will be collected, including choice of strategy, anastomotic leaks, 30- and 90- day complications, and mortality rates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Other: Indocyanine green |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients >18 years of age
- Acute physiologic derangement and suspected of having bowel ischemia
- Intraoperative finding of all-cause bowel ischemia with subsequent acute physiologic derangement
Key exclusion criteria (5 listed)
- Allergy toward; iodine, indocyanine green, or shellfish
- Liver insufficiency
- Thyrotoxicosis
- Pregnancy or lactation
- Permanently legally incompetent for any reason
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 |
|---|---|---|
| Indocyanine greenIntraoperative perfusion assessment with ICG Fluorescence Angiography (ICG-FA) in standard approved doses | Other | single arm |
Primary outcome
Change of strategy
Time frame: Assessed at day 30 and 90 after surgery
Change of intraoperative strategy due to ICG fluorescence angiography. Intraoperatively, a nurse will record the initial strategy, indication of resection in centimeters, before and after ICG angiography, and note whether there has been a change in strategy, and how.
8 secondary outcomes
Anastomosis
Time frame: Assessed at day 30 and 90 after surgery
Quantification using q-ICG
Time frame: 30 months
Stomas
Time frame: Assessed at day 30 and 90 after surgery
Second-look
Time frame: Assessed at day 30 and 90 after surgery
Anastomotic leaks
Time frame: Assessed at day 30 and 90 after surgery
Postoperative medical complications
Time frame: Assessed at day 30 and 90 after surgery
Postoperative surgical complications
Time frame: Assessed at day 30 and 90 after surgery
Mortality
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 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.
Sermed Ellebæk Nicolae, MD, PhDstudent principal investigator
Copenhagen University Hospital, Rigshospitalet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green in people with Bowel; Ischemic, Acute, run by Copenhagen University Hospital, Rigshospitalet at 5 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sermed Ellebæk Nicolae, MD, PhD-student (+45 3545 9666, sermed.nicolae@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of strategy (time frame: Assessed at day 30 and 90 after surgery). 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 15 Nov 2024.