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

NCT ID: NCT04020939

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-16
• Study Completion Date: 2021-03-10

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

SPY imaging

Intervention Type: DEVICE

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

Indocyanine Green

Intervention Type: DRUG

Intravenous injection of indocyanine green to evaluate the intestinal perfusion.

Interventions

SPY imaging

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

Intervention Type: DEVICE

Indocyanine Green

Intravenous injection of indocyanine green to evaluate the intestinal perfusion.

Intervention Type: DRUG

Other Intervention Names

SPY PinPoint; ICG; IC-Green

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nelson Piche

Pediatric Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nelson Piché, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

CHU Sainte-Justine

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2020-2359

Identifier Type: -

Identifier Source: org_study_id