Actively Recruiting

Phase Not Applicable
Age: 0 - 1Year
All Genders
NCT05735964

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

Led by Birmingham Women's and Children's NHS Foundation Trust · Updated on 2025-03-04

20

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to look at babies having a primary or delayed primary oesophageal repair for OA with dTOF to evaluate if using Indocyanine green (ICG) and near infrared fluorescence (NIRF) can decrease the rates of anastomotic leaks and/or predict which patients they will happen in. The latter evaluation would help counsel parents and mean that further research can evaluate if other tactics can prevent the leak being a moderate or severe problem. These may include, but not be limited to, extra anastomotic sutures, insertion of a chest drain at the time of surgery (if this had not previously been considered) delaying oral feeding or using medications to dry up the saliva prophylactically (these medications have been shown to reduce the length of time it takes leaks to seal). Any technique that can reduce leak rates in oesophageal atresia is to be welcomed. Additionally ICG may artifactually affect both peripheral oxygen readings (cause a transient decrease) and cerebral near infrared spectroscopy (NIRS) values (cause a transient increase). This is due to the temporary, dose dependent, interference of the dye with the mechanism of action of the monitoring rather than a physiological effect on oxygen levels. To date there has been no study investigating the effects of ICG on oxygen saturation and cerebral NIRS in neonates undergoing OA and/or dTOF repair. The theory is an extension from adult practice following oesophagectomy for cancer where there was a reduction in anastomotic leaks when using ICG/NIRF perfusion assessment. Another study in bariatric surgery using an enteral ICG/NIRF assessment was highly sensitive for anastomotic leaks allowing management of them intra-operatively. Objectives are to 1. Identify if the appearances of ICG/NIRF can predict anastomotic leaks 2. Identify if the ICG/NIRF images would engender a change in operative management leading to a reduced leak rate 3. Give a detailed report on the effects of ICG on oxygen readings This would be a cohort pilot study of 20 patients with the aim of informing a subsequent multi-centre Randomised controlled trial

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 1Year
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of oesophageal atresia with distal trachea-oesophageal fistula (OA/dTOF)
  • Planned primary or delayed primary oesophageal anastomosis
  • OA/dTOF diagnosis confirmed during surgery
  • Primary or delayed primary oesophageal anastomosis considered feasible clinically, physiologically, and technically
Not Eligible

You will not qualify if you...

  • Baby weighs under 2.5 kilograms
  • Complex heart disease
  • Allergy to Indocyanine Green (ICG)
  • Allergy to iodine or iodides
  • Hyperthyroidism
  • Chronic Kidney Disease stage V
  • Unwillingness to participate
  • Need for exchange transfusion due to high bilirubin levels
  • Anesthetic concerns preventing use of intravenous ICG due to effects on oxygen saturation readings

AI-Screening

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Trial Site Locations

Total: 1 location

1

Birmingham children's hospital

Birmingham, United Kingdom, B4 6NH

Actively Recruiting

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Research Team

M

max pachl

CONTACT

S

Sarah Hadfield

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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