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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: SPY imaging
* Drug: Indocyanine Green


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICG, intestinal resections, intestinal perfusion, SPY imaging, indocyanine green, pediatric surgery