NCT04020939

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: St. Justine's Hospital · Academic / Other
• Sex: All
• Age: 0 Years – 16 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	SPY imaging	Use of the SPY Pinpoint imaging device to evaluate intraoperative intestinal perfusion in children.
DRUG	Indocyanine Green	Intravenous injection of indocyanine green to evaluate the intestinal perfusion.

Timeline

• Start date: 2020-03-16
• Primary completion: 2021-03-10
• Completion: 2021-03-10
• First posted: 2019-07-16
• Last updated: 2021-03-17

Locations

1 site across 1 country: Canada