- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06322862
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sermed Ellebæk Nicolae, MD, PhD-student
- Phone Number: +45 3545 9666
- Email: sermed.nicolae@regionh.dk
Study Contact Backup
- Name: Michael Patrick Achiam, MD, PhD, DMSc
- Phone Number: +45 3545 0441
- Email: michael.patrick.achiam.01@regionh.dk
Study Locations
-
-
-
Bispebjerg, Denmark
- Not yet recruiting
- Department of Surgery, Bispebjerg Hospital
-
Contact:
- Peter Bonde, MD
-
Herlev, Denmark
- Not yet recruiting
- Department of Surgery, Herlev Hospital
-
Contact:
- Jakob Burcharth, MD, PhD
-
Hillerød, Denmark
- Not yet recruiting
- Department of Surgery, Nordsjællands Hospital
-
Contact:
- Mai-Britt Tolstrup, MD, PhD
-
Hvidovre, Denmark
- Not yet recruiting
- Department of Surgery, Hvidovre Hospital
-
Contact:
- Morten Laksafoss Lauritsen, MD
-
-
Hovedstaden
-
Copenhagen, Hovedstaden, Denmark, 2100
- Recruiting
- Department of Organ Surgery and Transplantation
-
Contact:
- Sermed Ellebæk Nicolae, MD
- Phone Number: +4535459666
- Email: sermed.ellebaek.nicolae@regionh.dk
-
Contact:
- Michael P Achiam, MD, DMSc
- Phone Number: +45 3545 0441
- Email: michael.patrick.achiam.01@regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Allergy toward; iodine, indocyanine green, or shellfish
- Liver insufficiency
- Thyrotoxicosis
- Pregnancy or lactation
- Permanently legally incompetent for any reason
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: single arm
|
Intraoperative perfusion assessment with ICG Fluorescence Angiography (ICG-FA) in standard approved doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of strategy
Time Frame: Assessed at day 30 and 90 after surgery
|
Change of intraoperative strategy due to ICG fluorescence angiography
|
Assessed at day 30 and 90 after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anastomosis
Time Frame: Assessed at day 30 and 90 after surgery
|
Number of anastomoses established in ICG-perfused bowel segments
|
Assessed at day 30 and 90 after surgery
|
Quantification using q-ICG
Time Frame: 30 months
|
A posthoc perfusion quantification using q-ICG software
|
30 months
|
Stomas
Time Frame: Assessed at day 30 and 90 after surgery
|
Number of cases where stoma was the preferred strategy
|
Assessed at day 30 and 90 after surgery
|
Second-look
Time Frame: Assessed at day 30 and 90 after surgery
|
Number of cases where second-look following bowel discontinuation, was the preferred strategy
|
Assessed at day 30 and 90 after surgery
|
Anastomotic leaks
Time Frame: Assessed at day 30 and 90 after surgery
|
Cases of anastomotic leaks postoperatively
|
Assessed at day 30 and 90 after surgery
|
Postoperative medical complications
Time Frame: Assessed at day 30 and 90 after surgery
|
Stratified by type and severity (Comprehensive Complication Index)
|
Assessed at day 30 and 90 after surgery
|
Postoperative surgical complications
Time Frame: Assessed at day 30 and 90 after surgery
|
Stratified by type and severity (Comprehensive Complication Index)
|
Assessed at day 30 and 90 after surgery
|
Mortality
Time Frame: 90 days
|
30- and 90-day mortality rates
|
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sermed Ellebæk Nicolae, MD, PhDstudent, Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-23042430
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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