Fluorescence Imaging, Gastrointestinal Tract Disorders, Genitourinary Disease, Perfusion
Conditions
Keywords
Paediatric Surgery, Pediatric Surgery, Fluorescence, Imaging, Fluorescence Guided Surgery (FGS), Intra-operative perfusion assessment, Indocyanine Green
Brief summary
The goal of this cohort study is to identify the lowest dose of Indocyanine Green (ICG) that achieves satisfactory intra-operative fluorescence for the assessment of gastrointestinal or genitourinary tract perfusion in children.
Detailed description
Indocyanine Green (ICG) fluorescence-guided surgery (FGS) can be used to assess gastrointestinal and genitourinary tract perfusion intra-operatively. In adults, the use of ICG has been shown to improve surgical outcomes. ICG is safely used intra-operatively in children, but there is a lack of evidence regarding the lowest clinically useful dose of ICG. This is a single centre open-label dose escalation study that aims to: 1. identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children (0 - 18 years old) 2. assess the safety profile of intra-operative ICG in children 3. characterise the intra-operative fluorescence of ICG in children
Interventions
DRUGIndocyanine Green (ICG)
Cohorts will receive 0.01 mg/kg, 0.02 mg/kg, 0.04mg/kg, 0.06 mg/kg, or 0.08 mg/kg intra-venous ICG at surgery. Patients will be consecutively allocated to different doses as per protocol.
Sponsors
Great Ormond Street Hospital for Children NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Dose escalation with backfilling.
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children aged ≤18 years of age * Elective surgery including gastrointestinal or genitourinary tract perfusion assessment
Exclusion criteria
* Renal and liver dysfunction * Active infection * Coagulopathy * Complex congenital heart defect * Previous documented allergy to ICG injection or other iodinated contrast agents * Patients suffering from hyperthyroidism or autonomic thyroid adenomas * Premature infants or neonates in whom exchange transfusion is indicated, due to the hyperbilirubinaemia risk * Concurrent use of sodium bisulphite-containing preparations, such as certain heparin preparations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum clinically useful dose of ICG in children | 60 minutes (intra-operative) | Identify the minimum dose of ICG at which intra-operative perfusion assessment is achieveable. Assessment will be based objectively on mean fluorescence intensity and the fluorescence-time curve, and subjectively by the operating surgeon. |
| Number of adverse drug events at each dose level | 30 days | An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complications | 30 days | Intra-operative and early postoperative complications and mortality (defined as an event observed within 30 days after surgery). Frequency and details. |
| Post-operative morbidity | 90 days | Further procedures, complications and mortality occuring within the 30 - 90 day time period (late post-operative complications). Frequency and details. |
| Length of stay | 90 days | Time in hospital post-procedure |
Countries
United Kingdom
Contacts
Primary ContactStefano Giuliani
Outcome results
None listed