FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indocyanine green.
- Who it may be relevant to
- Registry conditions: Bowel; Ischemic, Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery
Overview
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.
Interventions
- Other Indocyanine green
Intraoperative perfusion assessment with ICG Fluorescence Angiography (ICG-FA) in standard approved doses
Primary outcome measures
- Change of strategy [Time frame: Assessed at day 30 and 90 after surgery]
Secondary outcome measures (8)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Denmark · 5 centers
- Department of Organ Surgery and Transplantation — Copenhagen
- Department of Surgery, Bispebjerg Hospital — Bispebjerg
- Department of Surgery, Herlev Hospital — Herlev
- Department of Surgery, Nordsjællands Hospital — Hillerød
- Department of Surgery, Hvidovre Hospital — Hvidovre
Identifiers
NCT: NCT06322862 · H-23042430