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

Not Applicable

Completed

• Conditions: Intestinal Atresia; Necrotizing Enterocolitis; Hirschsprung Disease; Gastroschisis; Intestinal Obstruction; Incarcerated Hernia; Intussusception; Malrotation; Volvulus; Meconium Ileus
• Interventions: Device: SPY imaging; Drug: Indocyanine Green

• Registration Number: NCT04020939
• Lead Sponsor: St. Justine's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-12
• Study First Posted: 2019-07-16
• Study Start: 2020-03-16
• Status Verified: 2021-03
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing intestinal resections	SPY imaging	* 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
Patients undergoing intestinal resections	Indocyanine Green	* 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

Primary Outcome Measures

Name	Time	Method
SPY System utility in intestinal resections in Pediatric Surgery	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 Outcome Measures

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

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada