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

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.

Study Overview

• Status: Completed
• Conditions: Trauma; Necrotizing Enterocolitis; Intestinal Obstruction; Gastroschisis; Intussusception; Intestinal Atresia; Hirschsprung Disease; Incarcerated Hernia; Malrotation; Volvulus; Meconium Ileus; Intestinal Perforation
• Intervention / Treatment: Device: SPY imaging; Drug: Indocyanine Green

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1C5
      • CHU Sainte-Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients undergoing intestinal resections; 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	Device: SPY imaging; Use of the SPY Pinpoint imaging device to evaluate intraoperative intestinal perfusion in children.; Other Names: SPY PinPoint; Drug: Indocyanine Green; Intravenous injection of indocyanine green to evaluate the intestinal perfusion.; Other Names: ICG; IC-Green

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPY System utility in intestinal resections in Pediatric Surgery	To demonstrate the utility of intra-operative evaluation of intestinal viability using the SPY Fluorescence Imaging System to optimize the location of the resection margins in pediatric surgeries necessitating intestinal resections. - Rate of intestinal resection margins modifications by using the SPY technology	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complications	Number of anastomotic leaks; Number of strictures; Number of bowel obstructions	1 year
Length of stay	In days	1 year
Operative time	In minutes	30 days
Estimated blood losses	In ml	30 days
Need for additional reoperations	Number	1 year
Need for additional radiology interventions	Number	1 year

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Investigators: Principal Investigator: Nelson Piché, MD, St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2020
• Primary Completion (Actual): March 10, 2021
• Study Completion (Actual): March 10, 2021

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: SPY imaging; indocyanine green; pediatric surgery; ICG; intestinal resections; intestinal perfusion
• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Musculoskeletal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Musculoskeletal Abnormalities; Hernia; Digestive System Abnormalities; Megacolon; Enterocolitis; Enterocolitis, Necrotizing; Gastroschisis; Intussusception; Hirschsprung Disease; Intestinal Obstruction; Intestinal Perforation; Intestinal Atresia; Meconium Ileus
• Other Study ID Numbers: 2020-2359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No