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

Sponsor

Birmingham Women's and Children's NHS Foundation Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05735964

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Identify if the appearances of ICG/NIRF can predict anastomotic leaks
Identify if the ICG/NIRF images would engender a change in operative management leading to a reduced leak rate
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

Condition or Disease	Intervention/Treatment	Phase
Tracheo-Esophageal Fistula With Atresia of Esophagus	Drug: Indocyanine green	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Consecutive patientsConsecutive patients

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICG Patients in this single arm will receive ICG during their surgery	Drug: Indocyanine green Intravenous and endoluminal dosing

Arm

Intervention/Treatment

Experimental: ICG

Patients in this single arm will receive ICG during their surgery

Drug: Indocyanine green

Intravenous and endoluminal dosing

Outcome Measures

Primary Outcome Measures

Intravenous ICG [Within two weeks of surgery]
Number of patients with abnormal perfusion will have a clinical and/or radiological anastomotic leak
Enteral ICG [Within two weeks of surgery]
Number of patients in whom ICG given enterally shows an anastomotic leak

Secondary Outcome Measures

Delphi [Within a year following surgery]
Number of patients in whom ICG given prior to anastomosis causes a change in intra-operative plan
Peripheral oxygen saturations (SpO2) [Within a year following surgery]
In how many patients does the intravenous injection of ICG alter the peripheral oxygenation and/or near infrared spectroscopy readings.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1 Year

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham children's hospital	Birmingham		United Kingdom	B4 6NH

Sponsors and Collaborators

Birmingham Women's and Children's NHS Foundation Trust

Investigators

Principal Investigator: Max Pachl, Birmingham Women's and Children's NHS Foundation Trust, UK

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Birmingham Women's and Children's NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT05735964

Other Study ID Numbers:

22/BC/ONC/NO/633

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Esophageal Atresia

Esophageal Fistula

Tracheoesophageal Fistula

Fistula

Study Results

No Results Posted as of Feb 21, 2023