FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery (FLAMES)

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: Recruiting
• Conditions: Bowel; Ischemic, Acute
• Intervention / Treatment: Other: Indocyanine green

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: Interventional
• Enrollment (Estimated): 100
• 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

• Denmark
  • Bispebjerg, Denmark
    • Recruiting
    • Department of Surgery, Bispebjerg Hospital
    • Contact: Peter Bonde, MD
  • Herlev, Denmark
    • Recruiting
    • Department of Surgery, Herlev Hospital
    • Contact: Jakob Burcharth, MD, PhD
  • Hillerød, Denmark
    • Recruiting
    • Department of Surgery, Nordsjællands Hospital
    • Contact: Mai-Britt Tolstrup, MD, PhD
  • Hvidovre, Denmark
    • 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: Yes

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: single arm	Other: Indocyanine green; 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	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.	Assessed at day 30 and 90 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomosis	Number of anastomoses established in ICG-perfused bowel segments	Assessed at day 30 and 90 after surgery
Quantification using q-ICG	A posthoc perfusion quantification using q-ICG software	30 months
Stomas	Number of cases where stoma was the preferred strategy	Assessed at day 30 and 90 after surgery
Second-look	Number of cases where second-look following bowel discontinuation, was the preferred strategy	Assessed at day 30 and 90 after surgery
Anastomotic leaks	Cases of anastomotic leaks postoperatively	Assessed at day 30 and 90 after surgery
Postoperative medical complications	Stratified by type and severity (Comprehensive Complication Index)	Assessed at day 30 and 90 after surgery
Postoperative surgical complications	Stratified by type and severity (Comprehensive Complication Index)	Assessed at day 30 and 90 after surgery
Mortality	30- and 90-day mortality rates	90 days

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Sermed Ellebæk Nicolae, MD, PhDstudent, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: indocyanine green; perfusion assessment; acute care surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: H-23042430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No