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NCT04020939 Clinical Trial

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

Trauma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04020939
Other study ID # 2020-2359
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 16, 2020
Est. completion date March 10, 2021

Study information
Verified date March 2021
Source St. Justine's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date March 10, 2021
Est. primary completion date March 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 16 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Canada CHU Sainte-Justine Montréal Quebec

Sponsors (1)
Lead Sponsor Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Surgical complications Number of anastomotic leaks
Number of strictures
Number of bowel obstructions		 1 year
Secondary Length of stay In days 1 year
Secondary Operative time In minutes 30 days
Secondary Estimated blood losses In ml 30 days
Secondary Need for additional reoperations Number 1 year
Secondary Need for additional radiology interventions Number 1 year
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