Intestinal AtresiaNCT04020939
The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.
A study testing SPY imaging and Indocyanine Green in people with Intestinal Atresia and Necrotizing Enterocolitis, run by St. Justine's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Atresia, Necrotizing Enterocolitis, Hirschsprung Disease
- What is being tested?
- SPY imaging and Indocyanine Green
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 16 Mar 2020to 10 Mar 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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
- Being tested
- SPY imaging, Indocyanine Green
- Keywords
- SPY imaging, indocyanine green, pediatric surgery, ICG, intestinal resections, intestinal perfusion
- Medical subject headings
- Intestinal Atresia, Enterocolitis, Necrotizing, Hirschsprung Disease, Gastroschisis, Intestinal Obstruction, Intussusception, Volvulus Of Midgut, Intestinal Volvulus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPY imagingDevice
Also called SPY PinPoint
Use of the SPY Pinpoint imaging device to evaluate intraoperative intestinal perfusion in children.
Indocyanine GreenDrug
Also called ICG, IC-Green
Intravenous injection of indocyanine green to evaluate the intestinal perfusion.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: SPY imaging; Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (6)
Surgical complications
- Number of anastomotic leaks
- Number of strictures
- Number of bowel obstructions
Measured: 1 year
Length of stay
In days
Measured: 1 year
Operative time
In minutes
Measured: 30 days
Estimated blood losses
In ml
Measured: 30 days
Need for additional reoperations
Number
Measured: 1 year
Need for additional radiology interventions
Number
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start16 Mar 2020
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal AtresiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelson Piche, St. Justine's Hospital
- Investigators
- Nelson Piché, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020939
- Sponsor's protocol ID
- 2020-2359
- Status last verified
- Mar 2021
- First submitted
- 2 Jul 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No