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

Primary Purpose

Intestinal Atresia, Necrotizing Enterocolitis, Hirschsprung Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SPY imaging
Indocyanine Green
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Atresia focused on measuring SPY imaging, indocyanine green, pediatric surgery, ICG, intestinal resections, intestinal perfusion

Eligibility Criteria

0 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Sainte-Justine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients undergoing intestinal resections

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Surgical complications
Number of anastomotic leaks Number of strictures Number of bowel obstructions
Length of stay
In days
Operative time
In minutes
Estimated blood losses
In ml
Need for additional reoperations
Number
Need for additional radiology interventions
Number

Full Information

First Posted
July 2, 2019
Last Updated
March 15, 2021
Sponsor
St. Justine's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04020939
Brief Title
The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.
Official Title
The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Atresia, Necrotizing Enterocolitis, Hirschsprung Disease, Gastroschisis, Intestinal Obstruction, Incarcerated Hernia, Intussusception, Malrotation, Volvulus, Meconium Ileus, Intestinal Perforation, Trauma
Keywords
SPY imaging, indocyanine green, pediatric surgery, ICG, intestinal resections, intestinal perfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients undergoing intestinal resections
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
SPY imaging
Other Intervention Name(s)
SPY PinPoint
Intervention Description
Use of the SPY Pinpoint imaging device to evaluate intraoperative intestinal perfusion in children.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Other Intervention Name(s)
ICG, IC-Green
Intervention Description
Intravenous injection of indocyanine green to evaluate the intestinal perfusion.
Primary Outcome Measure Information:
Title
SPY System utility in intestinal resections in Pediatric Surgery
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Surgical complications
Description
Number of anastomotic leaks Number of strictures Number of bowel obstructions
Time Frame
1 year
Title
Length of stay
Description
In days
Time Frame
1 year
Title
Operative time
Description
In minutes
Time Frame
30 days
Title
Estimated blood losses
Description
In ml
Time Frame
30 days
Title
Need for additional reoperations
Description
Number
Time Frame
1 year
Title
Need for additional radiology interventions
Description
Number
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Piché, MD
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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