Clinical trial NCT04020939: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 35
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: SPY System utility in intestinal resections in Pediatric Surgery
timeFrame: 1 year
Secondary outcomes:
measure: Surgical complications
timeFrame: 1 year
measure: Length of stay
timeFrame: 1 year
measure: Operative time
timeFrame: 30 days
measure: Estimated blood losses
timeFrame: 30 days
measure: Need for additional reoperations
timeFrame: 1 year
measure: Need for additional radiology interventions
timeFrame: 1 year
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Nelson Piché, MD
role: PRINCIPAL_INVESTIGATOR
References: