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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • SPY System utility in intestinal resections in Pediatric Surgery
    • Time Frame: 1 year
    • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • St. Justine’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nelson Piche, Pediatric Surgeon – St. Justine’s Hospital
  • Overall Official(s)
    • Nelson Piché, MD, Principal Investigator, St. Justine’s Hospital
  • Overall Contact(s)
    • Annie Le-Nguyen, MD, 5146929694, annie.le-nguyen@outlook.com

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