FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery

NCT06322862 | Recruiting DMC

• 1 other identifier: H-23042430
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Bowel; Ischemic, Acute

Keywords

indocyanine green; perfusion assessment; acute care surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Anastomosis

  Assessed at day 30 and 90 after surgery

• Quantification using q-ICG

  30 months

• Stomas

  Assessed at day 30 and 90 after surgery

• Second-look

  Assessed at day 30 and 90 after surgery

• Anastomotic leaks

  Assessed at day 30 and 90 after surgery

Study Arms (1)

single arm

OTHER

Other: Indocyanine green

Interventions

Indocyanine green OTHER

Intraoperative perfusion assessment with ICG Fluorescence Angiography (ICG-FA) in standard approved doses

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergy toward; iodine, indocyanine green, or shellfish
• Liver insufficiency
• Thyrotoxicosis
• Pregnancy or lactation
• Permanently legally incompetent for any reason

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (5)

Department of Organ Surgery and Transplantation

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Department of Surgery, Bispebjerg Hospital

Bispebjerg, Denmark

RECRUITING

Department of Surgery, Herlev Hospital

Herlev, Denmark

RECRUITING

Department of Surgery, Nordsjællands Hospital

Hillerød, Denmark

RECRUITING

Department of Surgery, Hvidovre Hospital

Hvidovre, Denmark

RECRUITING

MeSH Terms

Conditions

Ischemia

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sermed Ellebæk Nicolae, MD, PhDstudent

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sermed Ellebæk Nicolae, MD, PhD-student

CONTACT

+45 3545 9666; sermed.nicolae@regionh.dk

Michael Patrick Achiam, MD, PhD, DMSc

CONTACT

+45 3545 0441; michael.patrick.achiam.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD, DMSc

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 21, 2024
• Study Start: March 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)