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Indocyanine Green for Pediatric Colorectal Conditions
Phase 3
Recruiting
Led By Andreana Butter, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient requires surgical management for their diagnosis
Patients greater than one-month of age to 7 years of age at the time of surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trialis studying how a special medication (ICG) can help improve outcomes in children with rare bowel diseases like HD and ARM by making their surgery safer.
Who is the study for?
This trial is for children aged 1 month to 7 years who need surgery for Hirschsprung's Disease or anorectal malformations. They must have had a physical exam, imaging studies, and in the case of HD, a pathologic diagnosis from rectal biopsies. Participants should understand English. Those with iodine allergies or without consent are excluded.Check my eligibility
What is being tested?
The study tests if Indocyanine Green (ICG), which highlights blood vessels during surgery, can help reduce complications like strictures or leaks after bowel surgeries in kids with specific colorectal conditions by improving visibility of blood flow.See study design
What are the potential side effects?
While ICG is generally safe and used in various adult surgeries, potential side effects may include allergic reactions due to its iodine content. However, it has been shown to be safe in children.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for my condition.
Select...
I am between 1 month and 7 years old at the time of my surgery.
Select...
I have been diagnosed with Hirschsprung's disease or anorectal malformations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of eligible paediatric patients treated for HD or ARM at the local institute that would qualify for participation in this trial.
The number of eligible paediatric patients treated for HD or ARM that enroll in this study and attend al required study visits.
The number of eligible paediatric patients treated for HD or ARM that enroll in this study during the recruitment period of this study.
+1 moreSecondary outcome measures
If the use of ICG alters the intraoperative management of the patient, resulting in the surgeon resecting a longer segment of bowel.
If the use of ICG alters the length of operative time between ICG and control group
If the use of ICG alters the length of stay in hospital between ICG and control group
+5 moreOther outcome measures
Adverse reaction to ICG resulting in adverse events/complications
Adverse reaction to ICG resulting in anaphylaxis
Adverse reaction to ICG resulting in drug interactions
+1 moreSide effects data
From 2015 Phase 2 trial • 30 Patients • NCT0166275297%
Wound pain
40%
Nausea
13%
Ileus
10%
Vomiting
7%
Bloating
7%
Urinary tract infection
3%
Atrial fibrillation
3%
Dizziness
3%
Palpitations
3%
Paroxysmal atrial fibrillation
3%
Constipations
3%
Distended abdomen
3%
Epigastric pain
3%
Hiccough
3%
Febrile reaction
3%
Rigors
3%
Postoperative ileus
3%
Low haemoglobin
3%
Groin pain
3%
Tremor
3%
Confusion
3%
Urinary retention
3%
Atelectasis
3%
Low blood pressure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Indocyanine Green
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Arm (Indocyanine Green [ICG])Experimental Treatment1 Intervention
The ICG group will involve the patient receiving standard care for either HD or ARM, in addition to 1.25mg (maximum dose less than 2mg/kg body weight) of ICG intraoperatively, administered intravenously. ICG will be administered by a member of the anesthesia team when directed by the surgeon (research team member).
Group II: Control Arm (Standard Care)Active Control1 Intervention
The Standard Care group will have no change to the medical and surgical care they receive while in the hospital. The surgeon will perform the surgery as they normally would outside of this study. This involves a laparoscopic-assisted transanal pullthrough surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine green
FDA approved
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
655 Previous Clinical Trials
413,327 Total Patients Enrolled
Andreana Butter, MDPrincipal InvestigatorPediatric Surgeon, Children's Hospital, LHSC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery for my condition.I am between 1 month and 7 years old at the time of my surgery.I have been diagnosed with Hirschsprung's disease or anorectal malformations.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm (Standard Care)
- Group 2: Treatment Arm (Indocyanine Green [ICG])
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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