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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micro-dosing Indocyanine Green (ICG) | Experimental | Multiple dose levels of intravenous Indocyanine Green (ICG) administered intra-operatively. Starting dose will be 10% of standard (for the study institution) and escalated as per protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green (ICG) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum clinically useful dose of ICG in children | 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. | 60 minutes (intra-operative) |
| Number of adverse drug events at each dose level | 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical complications | Intra-operative and early postoperative complications and mortality (defined as an event observed within 30 days after surgery). Frequency and details. | 30 days |
| Post-operative morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Giuliani | Contact | 02074059200 | 0669 | stefano.giuliani@gosh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Stefano Giuliani | Great Ormond Street Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Ormond Street Hospital for Children | Recruiting | London | WC1N 3JH | United Kingdom |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Dose escalation with backfilling.
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|
Further procedures, complications and mortality occuring within the 30 - 90 day time period (late post-operative complications). Frequency and details.
| 90 days |
| Length of stay | Time in hospital post-procedure | 90 days |