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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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