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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.
- ClinicalTrials.gov ID
- NCT04020939
- Acronym / sponsor ID
- 2020-2359
- Conditions
- Intestinal Atresia, Necrotizing Enterocolitis, Hirschsprung Disease, Gastroschisis, Intestinal Obstruction, Incarcerated Hernia
- Keywords
- SPY imaging, indocyanine green, pediatric surgery, ICG, intestinal resections, intestinal perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing intestinal resections | Experimental | Device: SPY imaging, Drug: Indocyanine Green* 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 |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPY imagingAlso: SPY PinPointUse of the SPY Pinpoint imaging device to evaluate intraoperative intestinal perfusion in children. | Device | Patients undergoing intestinal resections |
| Indocyanine GreenAlso: ICG, IC-GreenIntravenous injection of indocyanine green to evaluate the intestinal perfusion. | Drug | Patients undergoing intestinal resections |
Primary outcome
SPY System utility in intestinal resections in Pediatric Surgery
Time frame: 1 year
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
6 secondary outcomes
Surgical complications
Time frame: 1 year
Length of stay
Time frame: 1 year
Operative time
Time frame: 30 days
Estimated blood losses
Time frame: 30 days
Need for additional reoperations
Time frame: 1 year
Need for additional radiology interventions
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Intestinal Atresia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients With Short Bowel Syndrome
Short Bowel Syndrome
RecruitingObservational study
Molecular Genetics of Heterotaxy and Related Congenital Heart Defects
Heterotaxy Syndrome, Congenital Heart Defects
Not yet recruitingObservational study
Pattern And Outcome Of Neonatal Gastrointestinal Emergencies In Assiut University Children Hospital
Necrotizing Enterocolitis, Intestinal Atresia
Enrolling by invitation
Palliative Care Needs of Children With Rare Diseases and Their Families
Trisomy 13 Syndrome, Arthrogryposis Congenita Multiplex With Intestinal Atresia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelson Piché, MD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPY System utility in intestinal resections in Pediatric Surgery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.