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

Primary Purpose

Tracheo-Esophageal Fistula With Atresia of Esophagus

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Indocyanine green
Sponsored by
Birmingham Women's and Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tracheo-Esophageal Fistula With Atresia of Esophagus

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept 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

Sites / Locations

  • Birmingham children's hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICG

Arm Description

Patients in this single arm will receive ICG during their surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2022
Last Updated
February 9, 2023
Sponsor
Birmingham Women's and Children's NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05735964
Brief Title
Use of Indocyanine Green During Primary Repair of Oesophageal Atresia and Distal Tracheo-oesophageal Fistula
Acronym
iTOF
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Birmingham Women's and Children's NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheo-Esophageal Fistula With Atresia of Esophagus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Consecutive patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICG
Arm Type
Experimental
Arm Description
Patients in this single arm will receive ICG during their surgery
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Intervention Description
Intravenous and endoluminal dosing
Primary Outcome Measure Information:
Title
Intravenous ICG
Description
Number of patients with abnormal perfusion will have a clinical and/or radiological anastomotic leak
Time Frame
Within two weeks of surgery
Title
Enteral ICG
Description
Number of patients in whom ICG given enterally shows an anastomotic leak
Time Frame
Within two weeks of surgery
Secondary Outcome Measure Information:
Title
Delphi
Description
Number of patients in whom ICG given prior to anastomosis causes a change in intra-operative plan
Time Frame
Within a year following surgery
Title
Peripheral oxygen saturations (SpO2)
Description
In how many patients does the intravenous injection of ICG alter the peripheral oxygenation and/or near infrared spectroscopy readings.
Time Frame
Within a year following surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
max pachl
Phone
01213339999
Email
max.pachl@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Hadfield
Phone
01213339999
Email
sarah.hadfield2@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Pachl
Organizational Affiliation
Birmingham Women's and Children's NHS Foundation Trust, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham children's hospital
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data used in publications will be shared in peer-reviewed literature
Citations:
PubMed Identifier
32385707
Citation
Kalmar CL, Reed CM, Peery CL, Salzberg AD. Intraluminal indocyanine green for intraoperative staple line leak testing in bariatric surgery. Surg Endosc. 2020 Sep;34(9):4194-4199. doi: 10.1007/s00464-020-07606-4. Epub 2020 May 8.
Results Reference
background
PubMed Identifier
32995846
Citation
Schmedding A, Wittekindt B, Schloesser R, Hutter M, Rolle U. Outcome of esophageal atresia in Germany. Dis Esophagus. 2021 Apr 7;34(4):doaa093. doi: 10.1093/dote/doaa093.
Results Reference
background
PubMed Identifier
27894760
Citation
Long AM, Tyraskis A, Allin B, Burge DM, Knight M. Oesophageal atresia with no distal tracheoesophageal fistula: Management and outcomes from a population-based cohort. J Pediatr Surg. 2017 Feb;52(2):226-230. doi: 10.1016/j.jpedsurg.2016.11.008. Epub 2016 Nov 13.
Results Reference
background
PubMed Identifier
23334932
Citation
Burge DM, Shah K, Spark P, Shenker N, Pierce M, Kurinczuk JJ, Draper ES, Johnson PR, Knight M; British Association of Paediatric Surgeons Congenital Anomalies Surveillance System (BAPS-CASS). Contemporary management and outcomes for infants born with oesophageal atresia. Br J Surg. 2013 Mar;100(4):515-21. doi: 10.1002/bjs.9019. Epub 2013 Jan 18. Erratum In: Br J Surg. 2013 Jul;100(8):1117. Cusick, E [corrected to McNally, J]; de la Hunt, M [corrected to Hosie, G].
Results Reference
background
PubMed Identifier
25153838
Citation
Allin B, Knight M, Johnson P, Burge D; BAPS-CASS. Outcomes at one-year post anastomosis from a national cohort of infants with oesophageal atresia. PLoS One. 2014 Aug 25;9(8):e106149. doi: 10.1371/journal.pone.0106149. eCollection 2014.
Results Reference
background
PubMed Identifier
33051081
Citation
Comella A, Tan Tanny SP, Hutson JM, Omari TI, Teague WJ, Nataraja RM, King SK. Esophageal morbidity in patients following repair of esophageal atresia: A systematic review. J Pediatr Surg. 2021 Sep;56(9):1555-1563. doi: 10.1016/j.jpedsurg.2020.09.010. Epub 2020 Sep 19.
Results Reference
background
PubMed Identifier
31437328
Citation
Weber F, Scoones GP. A practical approach to cerebral near-infrared spectroscopy (NIRS) directed hemodynamic management in noncardiac pediatric anesthesia. Paediatr Anaesth. 2019 Oct;29(10):993-1001. doi: 10.1111/pan.13726. Epub 2019 Aug 29.
Results Reference
background
PubMed Identifier
21238638
Citation
Bishay M, Giacomello L, Retrosi G, Thyoka M, Nah SA, McHoney M, De Coppi P, Brierley J, Scuplak S, Kiely EM, Curry JI, Drake DP, Cross KM, Eaton S, Pierro A. Decreased cerebral oxygen saturation during thoracoscopic repair of congenital diaphragmatic hernia and esophageal atresia in infants. J Pediatr Surg. 2011 Jan;46(1):47-51. doi: 10.1016/j.jpedsurg.2010.09.062.
Results Reference
background
PubMed Identifier
28058473
Citation
Stolwijk LJ, van der Zee DC, Tytgat S, van der Werff D, Benders MJNL, van Herwaarden MYA, Lemmers PMA. Brain Oxygenation During Thoracoscopic Repair of Long Gap Esophageal Atresia. World J Surg. 2017 May;41(5):1384-1392. doi: 10.1007/s00268-016-3853-y.
Results Reference
background
PubMed Identifier
25844129
Citation
Baek HY, Lee HJ, Kim JM, Cho SY, Jeong S, Yoo KY. Effects of intravenously administered indocyanine green on near-infrared cerebral oximetry and pulse oximetry readings. Korean J Anesthesiol. 2015 Apr;68(2):122-7. doi: 10.4097/kjae.2015.68.2.122. Epub 2015 Mar 30.
Results Reference
background
PubMed Identifier
26981173
Citation
De Gasperi A, Mazza E, Prosperi M. Indocyanine green kinetics to assess liver function: Ready for a clinical dynamic assessment in major liver surgery? World J Hepatol. 2016 Mar 8;8(7):355-67. doi: 10.4254/wjh.v8.i7.355.
Results Reference
background
PubMed Identifier
32581443
Citation
Kulshrestha S, Kulshrestha M, Tewari V, Chaturvedi N, Goyal A, Sharma RK, Sarkar D, Tandon JN, Katyal V. Conservative Management of Major Anastomotic Leaks Occurring after Primary Repair in Esophageal Atresia with Fistula: Role of Extrapleural Approach. J Indian Assoc Pediatr Surg. 2020 May-Jun;25(3):155-162. doi: 10.4103/jiaps.JIAPS_73_19. Epub 2020 Apr 11.
Results Reference
background
PubMed Identifier
32158013
Citation
Cui X, He Y, Chen L, Lin Y, Zhang J, Zhou C. The Value of Thoracic Lavage in the Treatment of Anastomotic Leakage After Surgery for Type III Esophageal Atresia. Med Sci Monit. 2020 Mar 11;26:e919962. doi: 10.12659/MSM.919962.
Results Reference
background
PubMed Identifier
32143903
Citation
Campos J, Tan Tanny SP, Kuyruk S, Sekaran P, Hawley A, Brooks JA, Bekhit E, Hutson JM, Crameri J, McLeod E, Teague WJ, King SK. The burden of esophageal dilatations following repair of esophageal atresia. J Pediatr Surg. 2020 Nov;55(11):2329-2334. doi: 10.1016/j.jpedsurg.2020.02.018. Epub 2020 Feb 19.
Results Reference
background
PubMed Identifier
31535483
Citation
Donoso F, Hedenstrom H, Malinovschi A, E Lilja H. Pulmonary function in children and adolescents after esophageal atresia repair. Pediatr Pulmonol. 2020 Jan;55(1):206-213. doi: 10.1002/ppul.24517. Epub 2019 Sep 18.
Results Reference
background
PubMed Identifier
31486303
Citation
Guillen G, Lopez-Fernandez S, Molino JA, Bueno J, Lopez M. [Pilot experience with indocyanine green navigation in pediatric surgery]. Cir Pediatr. 2019 Jul 29;32(3):121-127. Spanish.
Results Reference
background
PubMed Identifier
30609438
Citation
Oetzmann von Sochaczewski C, Heimann A, Linder A, Kempski O, Muensterer OJ. Esophageal Blood Flow May Not Be Directly Influenced by Anastomotic Tension: An Exploratory Laser Doppler Study in Swine. Eur J Pediatr Surg. 2019 Dec;29(6):516-520. doi: 10.1055/s-0038-1676979. Epub 2019 Jan 4.
Results Reference
background
PubMed Identifier
30566986
Citation
Petit LM, Righini-Grunder F, Ezri J, Jantchou P, Aspirot A, Soglio DD, Faure C. Prevalence and Predictive Factors of Histopathological Complications in Children with Esophageal Atresia. Eur J Pediatr Surg. 2019 Dec;29(6):510-515. doi: 10.1055/s-0038-1676505. Epub 2018 Dec 19.
Results Reference
background
PubMed Identifier
29531469
Citation
Vergouwe FW, Gottrand M, Wijnhoven BP, IJsselstijn H, Piessen G, Bruno MJ, Wijnen RM, Spaander MC. Four cancer cases after esophageal atresia repair: Time to start screening the upper gastrointestinal tract. World J Gastroenterol. 2018 Mar 7;24(9):1056-1062. doi: 10.3748/wjg.v24.i9.1056.
Results Reference
background
PubMed Identifier
30558876
Citation
Agzarian J, Visscher SL, Knight AW, Allen MS, Cassivi SD, Nichols FC 3rd, Shen KR, Wigle D, Blackmon SH. The cost burden of clinically significant esophageal anastomotic leaks-a steep price to pay. J Thorac Cardiovasc Surg. 2019 May;157(5):2086-2092. doi: 10.1016/j.jtcvs.2018.10.137. Epub 2018 Nov 15.
Results Reference
background

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

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