An interventional study of SPY imaging and Indocyanine Green in Intestinal Atresia, Necrotizing Enterocolitis and Hirschsprung Disease, sponsored by St. Justine's Hospital. Completed at 1 site in Canada. Open to participants aged 0 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by St. Justine's Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
* 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 · Drug: Indocyanine Green
Use of the SPY Pinpoint imaging device to evaluate intraoperative intestinal perfusion in children.
Also known as: SPY PinPoint
Intravenous injection of indocyanine green to evaluate the intestinal perfusion.
Also known as: ICG, IC-Green
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
Time frame: 1 year
Surgical complications
* Number of anastomotic leaks * Number of strictures * Number of bowel obstructions
Time frame: 1 year
Length of stay
In days
Time frame: 1 year
Operative time
In minutes
Time frame: 30 days
Estimated blood losses
In ml
Time frame: 30 days
Need for additional reoperations
Number
Time frame: 1 year
Need for additional radiology interventions
Number
Time frame: 1 year
Plan to share: No
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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St. Justine's Hospital