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

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. 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

Timeline

Start

2023-03-01

Primary completion

2026-03

Completion

2026-03

Publications

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• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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