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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04020939
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Nelson Piche, St. Justine's Hospital

Brief 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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Patients undergoing intestinal resections
  • Interventions to be administered: indocyanine green intravenous injection and subsequent visualisation of intestinal viability under fluorescence
  • Drug:

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.
Other Names:
  • ICG
  • IC-Green




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Annie Le-Nguyen, MD 5146929694 annie.le-nguyen@outlook.com

Locations
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Canada, Quebec
CHU Sainte-Justine Recruiting
Montréal, Quebec, Canada, H3T 1C5
Contact: Annie Le-Nguyen, MD    5146929694    annie.le-nguyen@outlook.com   
Sponsors and Collaborators
St. Justine's Hospital
Investigators
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Principal Investigator: Nelson Piché, MD St. Justine's Hospital

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Responsible Party: Nelson Piche, Pediatric Surgeon, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT04020939    
Other Study ID Numbers: 2020-2359
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nelson Piche, St. Justine's Hospital:
SPY imaging
indocyanine green
pediatric surgery
ICG
intestinal resections
intestinal perfusion
Additional relevant MeSH terms:
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Gastroschisis
Enterocolitis
Enterocolitis, Necrotizing
Hirschsprung Disease
Intussusception
Intestinal Obstruction
Intestinal Perforation
Intestinal Atresia
Meconium Ileus
Hernia
Pathological Conditions, Anatomical
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Digestive System Abnormalities
Megacolon
Colonic Diseases