The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.

St. Justine's Hospital

Status: Completed

Conditions: Hirschsprung Disease; Meconium Ileus; Volvulus; Trauma; Malrotation; Intestinal Perforation; Necrotizing Enterocolitis; Gastroschisis; Incarcerated Hernia; Intestinal Obstruction; Intestinal Atresia; Intussusception

Treatments: Drug: Indocyanine Green; Device: SPY imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04020939

2020-2359

Details and patient eligibility

About

Background: Intestinal resections are commonly performed in the pediatric population. Perfusion of the bowel is one of the most important factors determining the viability of an intestinal anastomosis. Up to date, no ideal method to assess intestinal perfusion has proven its superiority.

Objectives:

Primary: The aim of this study is to establish the feasibility and impact of the use of indocyanine green technology on intestinal resection margins during elective and emergency pediatric surgeries.

Secondary: The secondary outcomes of interest include collection of adverse events and difficulties encountered with the use of the indocyanine green (ICG) technology. Postoperative surgical complications will also be recorded.

Study Design: An open observational clinical study will be performed by using a clinical drug (indocyanine green) and medical device (SPY Fluorescence Imaging) to assess intraoperatively intestinal perfusion in a specific pediatric population.

Enrollment: 35 patients

Sex: All

Ages: Under 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients < 16 years old
• Admitted between September 2019 and September 2020
• Patients undergoing a surgery at CHUSJ
• Any diagnosis requiring intra-abdominal intestinal resection (including stoma reversal)
• Written informed consent form from the parents or legal guardian

Exclusion criteria

• Patients > 16 years old
• Patients with known allergy or sensitivity to iodine
• Patients with known kidney or liver failure
• Patients with known severe cardiac or pulmonary diseases
• Informed consent unobtained or impossible due to refusal of parents, language barrier, or diminished comprehension

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Patients undergoing intestinal resections

Experimental group

Description:

* Interventions to be administered: indocyanine green intravenous injection and subsequent visualisation of intestinal viability under fluorescence * Drug: Indocyanine green dye (ICG) Dosage: 0.5 mg/kg (diluted with aqueous solution) Maximum: 2 mg/kg Frequency: maximum of 3 boluses Duration: intraoperative use only

Treatment:

Device: SPY imaging

Drug: Indocyanine Green