Clinical trial NCT06322862: FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery
Official title: Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bowel; Ischemic, Acute
Keywords: indocyanine green
perfusion assessment
acute care surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of strategy
timeFrame: Assessed at day 30 and 90 after surgery
Secondary outcomes:
measure: Anastomosis
timeFrame: Assessed at day 30 and 90 after surgery
measure: Quantification using q-ICG
timeFrame: 30 months
measure: Stomas
timeFrame: Assessed at day 30 and 90 after surgery
measure: Second-look
timeFrame: Assessed at day 30 and 90 after surgery
measure: Anastomotic leaks
timeFrame: Assessed at day 30 and 90 after surgery
measure: Postoperative medical complications
timeFrame: Assessed at day 30 and 90 after surgery
measure: Postoperative surgical complications
timeFrame: Assessed at day 30 and 90 after surgery
measure: Mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Organ Surgery and Transplantation
state: Hovedstaden
city: Bispebjerg
country: Denmark
facility: Department of Surgery, Bispebjerg Hospital
city: Herlev
country: Denmark
facility: Department of Surgery, Herlev Hospital
city: Hillerød
country: Denmark
facility: Department of Surgery, Nordsjællands Hospital
city: Hvidovre
country: Denmark
facility: Department of Surgery, Hvidovre Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Sermed Ellebæk Nicolae, MD, PhDstudent
role: PRINCIPAL_INVESTIGATOR
References: