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OpenTrials
Completed

NCT Number: NCT04020939

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

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.

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Key information

Conditions

Intestinal Atresia Colonic Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Gastroschisis Hernia Hernia, Abdominal Hirschsprung Disease Incarcerated Hernia Intestinal Diseases Intestinal Obstruction Intestinal Perforation Intestinal Volvulus Intussusception Malrotation Meconium Ileus Megacolon Musculoskeletal Abnormalities Musculoskeletal Diseases Necrotizing Enterocolitis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Torsion Abnormality Trauma Volvulus Volvulus Of Midgut Wounds and Injuries

Age range

0 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPY imaging

Device

Use of the SPY Pinpoint imaging device to evaluate intraoperative intestinal perfusion in children.

Other names: SPY PinPoint

Indocyanine green

Drug

Intravenous injection of indocyanine green to evaluate the intestinal perfusion.

Other names: ICG, IC-Green

Primary outcomes

  1. 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

Secondary outcomes

  1. Surgical complications

    Time frame: 1 year

    • Number of anastomotic leaks
    • Number of strictures
    • Number of bowel obstructions

  2. Length of stay

    Time frame: 1 year

    In days

  3. Operative time

    Time frame: 30 days

    In minutes

  4. Estimated blood losses

    Time frame: 30 days

    In ml

  5. Need for additional reoperations

    Time frame: 1 year

    Number

  6. Need for additional radiology interventions

    Time frame: 1 year

    Number

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2019
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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