Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery

Bowel; Ischemic, Acute Clinical Trial

Official title:

Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322862
• Other study ID #: H-23042430
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: March 2024
• Source: Rigshospitalet, Denmark
• Contact: Sermed Ellebæk Nicolae, MD, PhD-student
• Phone: +45 3545 9666
• Email: sermed.nicolae[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel; Ischemic, Acute
• Emergencies

Intervention

Other:
• Indocyanine green
Intraoperative perfusion assessment with ICG Fluorescence Angiography (ICG-FA) in standard approved doses

Locations

Country	Name	City	State
Denmark	Department of Surgery, Bispebjerg Hospital	Bispebjerg
Denmark	Department of Organ Surgery and Transplantation	Copenhagen	Hovedstaden
Denmark	Department of Surgery, Herlev Hospital	Herlev
Denmark	Department of Surgery, Nordsjællands Hospital	Hillerød
Denmark	Department of Surgery, Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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