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

NCT04020939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-03-17

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Nelson Piché, MD · St. Justine's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-16
Primary Completion
2021-03-10
Completion
2021-03-10

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04020939 on ClinicalTrials.gov