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

NCT04020939 | Completed

• 1 other identifier: 2020-2359
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (6)

• Surgical complications

  1 year

• Length of stay

  1 year

• Operative time

  30 days

• Estimated blood losses

  30 days

• Need for additional reoperations

  1 year

Study Arms (1)

Patients undergoing intestinal resections

EXPERIMENTAL

* 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; Drug: Indocyanine Green

Interventions

SPY imaging DEVICE

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

Also known as: SPY PinPoint

Patients undergoing intestinal resections

Indocyanine Green DRUG

Intravenous injection of indocyanine green to evaluate the intestinal perfusion.

Also known as: ICG, IC-Green

Patients undergoing intestinal resections

Eligibility Criteria

• Age: 0 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Intestinal Atresia; Enterocolitis, Necrotizing; Hirschsprung Disease; Gastroschisis; Intestinal Obstruction; Intussusception; Volvulus Of Midgut; Intestinal Volvulus; Meconium Ileus; Intestinal Perforation; Wounds and Injuries

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Enterocolitis; Gastroenteritis; Megacolon; Colonic Diseases; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Torsion Abnormality

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nelson Piché, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Surgeon

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 16, 2019
• Study Start: March 16, 2020
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)