The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.
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|ClinicalTrials.gov Identifier: NCT04020939|
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : March 18, 2020
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Intestinal Atresia Necrotizing Enterocolitis Hirschsprung Disease Gastroschisis Intestinal Obstruction Incarcerated Hernia Intussusception Malrotation Volvulus Meconium Ileus Intestinal Perforation Trauma||Device: SPY imaging Drug: Indocyanine Green||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.|
|Estimated Study Start Date :||March 16, 2020|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||January 1, 2021|
Experimental: Patients undergoing intestinal resections
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 Name: SPY PinPoint
Drug: Indocyanine Green
Intravenous injection of indocyanine green to evaluate the intestinal perfusion.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020939
|Contact: Annie Le-Nguyen, MDfirstname.lastname@example.org|
|Montréal, Quebec, Canada, H3T 1C5|
|Contact: Annie Le-Nguyen, MD 5146929694 email@example.com|
|Principal Investigator:||Nelson Piché, MD||St. Justine's Hospital|