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

NCT05735964 | Recruiting

• 1 other identifier: 22/BC/ONC/NO/633
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

1. 1.Identify if the appearances of ICG/NIRF can predict anastomotic leaks
2. 2.Identify if the ICG/NIRF images would engender a change in operative management leading to a reduced leak rate
3. 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

Tracheo-Esophageal Fistula with Atresia of Esophagus

Outcome Measures

Primary Outcomes (2)

• Intravenous ICG

  Number of patients with abnormal perfusion will have a clinical and/or radiological anastomotic leak

  Within two weeks of surgery

• Enteral ICG

  Number of patients in whom ICG given enterally shows an anastomotic leak

  Within two weeks of surgery

Secondary Outcomes (2)

• Delphi

  Within a year following surgery

• Peripheral oxygen saturations (SpO2)

  Within a year following surgery

Study Arms (1)

ICG

EXPERIMENTAL

Patients in this single arm will receive ICG during their surgery

Drug: Indocyanine green

Interventions

Indocyanine green DRUG

Intravenous and endoluminal dosing

ICG

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Birmingham Women's and Children's NHS Foundation Trust: lead

Study Sites (1)

Birmingham children's hospital

Birmingham, B4 6NH, United Kingdom

RECRUITING

Related Publications (20)

• 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.

  PMID: 32385707 BACKGROUND

• 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.

  PMID: 32995846 BACKGROUND

• 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.

  PMID: 27894760 BACKGROUND

• 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.

  PMID: 23334932 BACKGROUND

• 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.

  PMID: 25153838 BACKGROUND

• 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.

  PMID: 33051081 BACKGROUND

• 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.

  PMID: 31437328 BACKGROUND

• 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.

  PMID: 21238638 BACKGROUND

• 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.

  PMID: 28058473 BACKGROUND

• 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.

  PMID: 25844129 BACKGROUND

• 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.

  PMID: 26981173 BACKGROUND

• 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.

  PMID: 32581443 BACKGROUND

• 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.

  PMID: 32158013 BACKGROUND

• 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.

  PMID: 32143903 BACKGROUND

• 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.

  PMID: 31535483 BACKGROUND

• 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.

  PMID: 31486303 BACKGROUND

• 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.

  PMID: 30609438 BACKGROUND

• 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.

  PMID: 30566986 BACKGROUND

• 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.

  PMID: 29531469 BACKGROUND

• 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.

  PMID: 30558876 BACKGROUND

MeSH Terms

Conditions

Esophageal atresia with or without tracheoesophageal fistula

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Max Pachl

  Birmingham Women's and Children's NHS Foundation Trust, UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

max pachl

CONTACT

01213339999; max.pachl@nhs.net

Sarah Hadfield

CONTACT

01213339999; sarah.hadfield2@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Consecutive patients

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: February 21, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 4, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)