Safety and Feasibility of Indocyanine Green Fluorescence for Intraoperative Assessment of Intestinal Perfusion in Young Infants and Neonates

NCT ID: NCT05734118

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-08-31

Brief Summary

The goal of this clinical trial is to test the use of the SPY-PHI device for the purpose of ICG-mediated intestinal perfusion visualization during gastrointestinal surgery in neonates and young infants (<3 months old) undergoing surgery for NEC, atresia, SIP or malrotation. The main question[s] it aims to answer are:

• Is ICG-FA feasible for intraoperative use in neonates and young infants undergoing laparotomy for NEC, atresia, SIP or malrotation?
• Is ICG-FA is safe to use in neonates during surgery?

Participants will undergo surgical care for their diseases within the standard of care. During laparotomy, the pediatric surgeon will assess bowel perfusion in two ways. First, by visual inspection (the conventional method). Second, the intestine will be analyzed with indocyanine green fluorescence angiography (ICG-FA) by means of the hand-held SPY-PHI camera. For this purpose, the patients will be administered ICG intravenously. Afterwards, the intestinal perfusion will be assessed by means of the SPY-PHI device in 5 to 10 minutes.

Specifically, the feasibility and safety for use of ICG-FA in neonates undergoing laparotomy as treatment for necrotizing enterocolitis (NEC), atresia, spontaneous intestinal perforation (SIP) and malrotation will be investigated.

If ICG-FA turns out to be feasible and safe for the population investigated in this study, a follow-up study will be conducted with the aim to explore the potential benefits of this technique on the postoperative outcome and intraoperative decision-making.

Detailed Description

This study aims to investigate whether the intraoperative use of indocyanine green fluorescence angiography (ICG-FA) is feasible and safe in neonates. Feasibility is therein defined as practically possible use of ICG-FA, resulting in clear and interpretable results, with the future potential to improve clinical outcome and benefits for the patient.

Specifically, the feasibility and safety for use of ICG-FA in neonates undergoing laparotomy as treatment for necrotizing enterocolitis (NEC), atresia, spontaneous intestinal perforation (SIP) and malrotation will be investigated.

If ICG-FA turns out to be feasible and safe for the population investigated in this study, a follow-up study will be conducted with the aim to explore the potential benefits of this technique on the postoperative outcome and intraoperative decision-making.

The primary endpoint of this study is assessing the feasibility and safety of intraoperative ICG-FA imaging in neonates undergoing laparotomy for NEC, atresia, SIP, or malrotation. The secondary endpoint of this study is postoperative comparison of the images; standard visual inspection (conventional image) with the corresponding fluorescence image.

During laparotomy, first the pediatric surgeon performs the visual inspection of the predetermined areas (mid jejunum, ileum, ascending colon and sigmoid) as well as regions of interest such as ischemic lesions in NEC and malrotation with volvulus. In case of intestinal necrosis, both edges of the parts that will be resected must be marked with a suture. Second, the intestine will be analyzed using ICG-FA. This analysis will cover the predetermined areas as well as regions of interest.

To this end, the ICG should be injected intravenously by the one member of the anesthetic team. This will only be done if the operating team, consisting of both the consultant surgeon and consultant pediatric anesthesiologist, consider it safe to do so. Utilizing the mobile unit with computer and camera head, the fluorescence angiography system can measure tissue perfusion. Before the start of the procedure in which the SPY-PHY camera will be used intraoperatively, the camera will be covered with sterile drapes. The pediatric surgeon will first make conventional video images with the camera of the predetermined areas and the region of interest and second, the surgeon will make images of the ICG-FA with the camera, which both will be recorded to be analyzed later.

The ICG-FA images do not alter the decision on what type of surgical procedure will be performed and/or how much length of bowel will be resected. In case of a difficult decision, a second pediatric surgeon will be consulted, which is routine clinical practice in both centers anyway.

Conditions

NEC; Atresia; Malrotation; Intestinal Perforation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intraoperative perfusion assessment using ICG-FA

Surgical procedure within standard of care. Intraoperatively, the vitality of the bowel will be assessed visually (the conventional method). Afterwards, participants will be administered indocyanine green intravenously.

Group Type: EXPERIMENTAL

Perfusion assessment by means of the SPY-PHI camera

Intervention Type: DEVICE

Minutes after injection of ICG, the intestinal perfusion can and will be assessed using the SPY-PHI camera by Stryker Endoscopy. The operative plan will not be changed based on the results of the perfusion assessment. Images will be recorded and evaluated postoperatively.

Interventions

Perfusion assessment by means of the SPY-PHI camera

Minutes after injection of ICG, the intestinal perfusion can and will be assessed using the SPY-PHI camera by Stryker Endoscopy. The operative plan will not be changed based on the results of the perfusion assessment. Images will be recorded and evaluated postoperatively.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Written informed consent is obtained by both patient's parents or legal guardians (as applicable);
• Patient is a neonate (< 1 month of age) or young infant (<3 months of age);
• Patient is suffering from necrotizing enterocolitis, atresia, malrotation or spontaneous intestinal perforation;
• Patient requires laparotomy for management of the disease.

Exclusion Criteria

• Patient is suffering from clinically significant (treatment necessary) hyperbilirubinemia;
• Patient is suffering from thyroid or liver disease;
• Patient is allergic to the active substance indocyanine green or sodium iodide or iodine;
• Patient has abdominal wall defects;
• Patient can be treated non-surgically;
• During the preoperative multidisciplinary meeting with the team, including the pediatric anesthetist, patient is deemed not stable enough hemodynamically to perform the ICG-FU measurements
• Patient is assessed unstable by operating team intraoperatively.

• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMC Utrecht

OTHER

Sponsor Role: collaborator

Stryker Endoscopy

INDUSTRY

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Hulscher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Groningen

Central Contacts

Eline Breuking, MB, LLB

Role: CONTACT

e.a.breuking2@students.uu.nl

0887554070

Otis van Varsseveld, MD

Role: CONTACT

o.c.van.varsseveld@umcg.nl

0503614796

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Related Links

https://db.cbg-meb.nl/bijsluiters/h31052.pdf

Verdye Indocyanine Green description (Dutch)

Other Identifiers

IMAGINE

Identifier Type: -

Identifier Source: org_study_id