Using Indocyanine Green to Improve Surgery for Esophageal Atresia in Babies
Indocyanine Green (ICG) and Near Infrared Fluorescence (NIRF) Guided Assessment of the Bowel and Oesophageal Anastomosis During Repair of Oesophageal Atresia with Distal Trachea-oesophageal Fistula (OA/dTOF): a Cohort Pilot Study
This study is testing if a special dye can help doctors do better surgeries for babies with a condition called esophageal atresia by reducing complications and improving recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 1 Year |
| Sex | All |
| Sponsor | Birmingham Women's and Children's NHS Foundation Trust Academic / other |
| Locations | 1 site (Birmingham) |
| Trial ID | NCT05735964 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of Indocyanine Green (ICG) and near-infrared fluorescence (NIRF) during the surgical repair of esophageal atresia with distal tracheo-esophageal fistula in infants. The aim is to determine if these technologies can reduce the rates of anastomotic leaks and predict which patients are at risk for such complications. By assessing tissue perfusion and potential ischemia before and after the anastomosis, the study seeks to improve surgical outcomes and reduce hospital stays. Additionally, it will monitor the effects of ICG on oxygen saturation readings in neonates undergoing this procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are infants diagnosed with esophageal atresia and distal tracheo-esophageal fistula who are scheduled for primary or delayed primary anastomosis.
Not a fit: Patients who may not benefit include those with complex cardiac disease, severe allergies to ICG or iodine, or those weighing less than 2.5 kg.
Why it matters
Potential benefit: If successful, this approach could significantly reduce complications and improve recovery times for infants undergoing surgery for esophageal atresia.
How similar studies have performed: While the use of ICG in surgical settings is gaining interest, this specific application in esophageal atresia is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham
- Birmingham children's hospital — Birmingham, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Max Pachl — Birmingham Women's and Children's NHS Foundation Trust, UK
- Study coordinator: max pachl
- Email: max.pachl@nhs.net
- Phone: 01213339999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.