Use of Indocyanine Green During Primary Repair of Oesophageal Atresia and Distal Tracheo-oesophageal Fistula

Anastomotic leaks can have wide ranging consequences. If they can be predicted and/or prevented clinical outcomes for patients would be improved along with shorter length of stay and reduced cost to the national health service (NHS) in the short, medium, and long term. These patients would require less bed days both on inpatient wards and paediatric intensive care units enabling the management of other children.

This study will evaluate if ICG/NIRF tissue perfusion diagnostics can show if the fistula (distal oesophagus) end is ischaemic (has poor blood flow) prior to anastomosis. Ischaemic ends are well recognised to relate to leakage although in OA the role of mucosal apposition is poorly understood. This intervention would afford the operator the opportunity to perform a fully vascularised join if feasible and also indicate if ischaemia predicts anastomotic leaks.

It will also evaluate if post-anastomosis intravenous and enteral dosing of ICG with NIRF assessment is able to predict those who will suffer from a leak whether that be clinical or radiological.

There is little data on the effect of ICG on peripheral oxygen saturation readings, or of its effect on near infrared spectroscopy readings in neonates. This study will record the effects on peripheral saturation and near-infrared spectroscopy readings which are used routinely in babies having this type of surgery. It will compare these readings to arterial blood oxygenation readings from a blood gas analyser. Blood gases are routinely taken during this procedure and so this will not involve any extra blood testing over and above what is ordinarily performed.

Inclusion criteria

Pre-operative

• Diagnosis of oesophageal atresia with distal trachea-oesophageal fistula (OA/dTOF)
• Plan for primary or delayed primary oesophageal anastomosis

Intra-operative

• Diagnosis of OA/dTOF confirmed by standard methods
• Primary or delayed primary oesophageal anastomosis considered clinically, physiologically, and technically feasible

Exclusion criteria

Pre-operative

• Under 2.5kg in weight
• Complex cardiac disease
• Allergic to ICG
• Allergic to iodine or iodides
• Hyperthyroidism
• Chronic Kidney Disease stage V
• Unwilling to participate
• Those in whom exchange transfusion is indicated due to hyperbilirubinemia

Intra-operative

• Anaesthetic concerns contra-indicating the use of intravenous ICG due its temporary effect on oxygen saturation readings prior to injection of ICG