Introduction and review of literature:

Congenital esophageal atresia is one of the most common correctable GI anamoly with an incidence of approximately 1 in 2500 live births.¹ Esophageal atresia (EA) with or without tracheoesophageal fistula (TEF) remains one of the most common surgically correctable gastrointestinal malformations and has been documented to have  improving survival rates since the original description of its repair and primary anastomosis in 1943 by Haight.²

However, post-operative anastomotic strictures (AS) complicate the course in 9-79% of cases with esophageal atresia with or without tracheoesophageal fistula repair.^3-6 An anastomotic strictre following esophageal atresia repair is defined as a narrowing that results in symptoms or signs such as dysphagia, regurgitation, oxygen desaturation during feeding, aspiration and failure to thrive.⁷

Factors contribute to the development of anastomotic stricture are; tension on the anastomosis, associated gastroesophageal reflux disease which these children are prone to and the presence of a leak in the early postoperative period.³

There is limited information about esophageal strictures in children from India. A study on 107 chidlren from Chandigarh has shown that corrosive strictures are the most common etiology (54%) followed by anasmototic strictures (11%).⁸ Our own experience at SGPGI showed an increasing number of anastomotic stricture cases over the last 5years requiring dilatation. Wire-guided polyvinyl bougie dilators (Savary Gilliard) and “through-the-scope balloons” are the most frequently used material to dilate benign esophageal strictures.⁹

Endoscopic esophageal dilatation remains the mainstay of treatment for anastomotic stricture. ⁹

Conventionally bougie dilatation is used and is shown to be effective in dilating esophageal anastomotic strictures in infants and children. In a study with 107 children in a tertiary care hospital in North India, 104/107 children were successfully dilated (93.7%) with bougie.⁸

Nevertheless, balloon dilatation has gained prominence ever since its introduction over the last 25years. Balloon is shown to be effective in dilating esophageal anastomotic strictures in infants and children.⁹There are advantages of balloon over bougie in terms of efficacy and complications. Balloon exerts radial force at the site of structure whereas bougie applies tangential force resulting in more tissue damage. ¹⁰ In a study by Salo et al. with a cohort of 49 children  with esophageal atresia that if  patients were dilated early, within 6 months, they would need prolonged but

not significantly more dilatations than those who may need a dilatation after 6 months postoperatively

However, there is no prospective randomized trial to compare the efficacy between bougie and balloon in benign esophageal anastomotic stricture post esophageal atresia repair.¹¹

In a retrospective study of 34 children with post-esophageal atresia repair anastomotic stricture, Lang et al. have compared their experience of bougienage in 18 children with 16 children who received balloon dilatation and found that balloon dilation was more effective and less traumatic than bougienage for dilatation in children with anastomotic strictures. ¹² Esophageal perforation  is a known complication  of dilatation of esophageal strictures.Perforation is less common in dilatation of esophageal anastomotic stricture than corrosive stricture .However perforations have been reported in dilatation of esophageal anastomotic strictures post esophageal atresia repair.¹³

Thyoka et al showed 1 %perforation rate over total number of 378 balloon dilatation sessions in 103 patients with post esophageal atresia anastomotic strictures.¹⁴Perforation rate for bougie dilatation was reported to be 0.9% in 648 dilatations for benign esophageal strictures including corrosive, anastomotic and other causes in a study from North India.⁸ 

Hence, this study would help in identifying if there is any difference, if so which is the better modality over other in the dilatation of anastomotic strictures post esophageal atresia repair.

 Aim of the study

To compare the efficacy of balloon versus bougie dilatation in post esophageal atresia repair anastomotic stricture.

 Methodology

 Place of study: Department of Paediatric Gastroenterology, SGPGI

Time of study: March 2019 to December 2020 (after obtaining ethical clearance)

Study design: Prospective randomised trial. 

Inclusion criteria

1.      All children of either sex between 1month to 10yrs of age attending Pediatric Gastroenterology services diagnosed to have symptomatic esophageal anastomotic stricture following esophageal atresia repair.

Exclusion criteria

1.      Benign esophageal strictures of other etiologies like corrosive, post-sclerotherapy, congenital, peptic etc.

2.      In caseses where guide wire could not be negotiated.

3.       Refusal to give consent.

4.      Children with history of prior dilatation.

Materials andn Methods:

Consecutive children, presenting to Pediatric Gastroenterology services and diagnosed to have symptomatic anastomotic stricture following esophageal atresia repair will be enrolled in the study after getting written informed consent from the either parent and subsequent methods to be followed are summarized in the flow chart.

Baseline clinical characteristics, surgical details and anthropometry will be noted in the proforma.

Contrast esophagogram will be obtained before first session of dilatation in all children.

During the same visit, all the diagnosed children will be started on appropriate dose of proton pump inhibitor to remove confounding factor of reflux mediated further stricturisation.

 All children coming for dilatation for the first time, meeting the inclusion criteria, after getting a contrast esophagogram will be randomised. Randomisation will be done by computer generated random table into two arms; bougie and balloon.

All children in both the arms will be sedated using IV midazolam 0.1mg/kg and IV ketamine 1mg/kg as the practice in our endoscopy unit. If there is a tight stricture, Sohendra’s Biliary Dilating Catheter (SBDC) may be permitted to open the stricture for the first session only. Subsequent dilatation will be followed as per the protocol.

Target dilatation :-

  The esophageal lumen dilated to 12mm with no dysphagia for age appropriate food for 3months in children <5yr of age and 15mm with no dysphagia for age appropriate food for 3months children >5yr of age.

In the bougie dilatation group, dilatations will be started with 5mm bougie (American Bard bougie) and will be increased progressively. In one session up to 3 sizes after getting resistance will be used. The dilatation will be repeated 2 weekly until the target dilatation is achieved.The dilatatioin will be done under fluoroscopic guidance.

 In the Balloon dilatation group, the starting diameter of balloon will be 6mm (smallest available through the scope balloon) and shall be progressvily increased depending on the tightness of the stricture (target will be disappearance of the waist and there from balloon will be kept inflated for 2-3 minutes). The dilatation will be repeated every 2 weekly until the target dilatation is achieved. This will also be done under fluoroscopic guidance with contrast.

Once the target dilatation is achieved the number of dilatation sessions required to achieved the target will be assessed in both groups and will be taken as primary outcome.

If the child develops symptoms after achieveing target dilatation, further as needed dilatations will be done in the follow-up and that will be counted as secondary outcome.

 References:

 1.Spitz Lewis. Oesophageal atresia. Orphanet Journal of Rare Diseases 2007, 2:24

 2.Haight C, Towsley HA. Congenital atresia of the esophagus with tracheoesphageal fistula:    extrapleural ligation of fistula and endto-end anastomosis of esophageal segments. Surg Gynecol    Obstet.1943;76:672–688

 3.     Baird R, Laberge JM, Lévesque D. Anastomotic stricture after esophageal atresia repair: a critical review of recent literature.Eur J Pediatr Surg 2013;23(03):204–213

 4.  Allin B, Knight M, Johnson P, Burge D; BAPS-CASS. Outcomes at one-year post anastomosis from a national cohort of infants withoesophageal atresia. PLoS One 2014;9(08):e106149

 5. Dingemann C, Dietrich J, Zeidler J, et al. Early complications afteresophageal atresia repair: analysis of a German health insurance database covering a population of 8million. Dis Esophagus 2016;29(07):780–786.

 6. Landisch RM, Foster S, Gregg D, et al. Utilizing stricture indices topredict dilation of strictures     after esophageal atresia repair. J SurgRes 2017;216:172–178.

 7 Laberge JM. Esophageal atresia and tracheo-esophageal fistula. In: Mattei P, ed. Fundamentals of Pediatric Surgery. New York: Springer; 2011:223–232

8.Poddar U, Thapa BR. Benign esophageal strictures in infants and

children: results of Savary-Gilliard bougie dilation in 107 Indian children. Gastrointest Endosc 2001;54(4):480–484

9 Broor SL, Lahoti D, Bose PP, Ramesh GN, Raju GS, Kumar A.Benign esophageal strictures inchildren and adolescents etiology,clinical profile, and results of endoscopic dilation.Gastrointest Endosc 1996;43:474-7

10. Said M, Mekki M, Golli M et al (2003) Balloon dilatation of anastomotic strictures secondary to surgical repair of oesophagealatresia. Br J Radiol 76:26–31

 11.Lang T, Hummer HP, Behrens R. Balloon dilation is preferable to bougienage in children with esophageal atresia. Endoscopy 2001;33(4):329–335.

Surg J2018;4:e62–e65.

 13. Lan LCL, Wong KKY, Lin SCL (2003) Endoscopic balloon dilatation of

esophageal strictures in infants and children: 17 years’ experience and a literature review. J Pediatr Surg 38: 1712-1715

14. Thyoka M, Alex B, Samantha C et al. Fluoroscopic Balloon Dilation of

esophageal atresia anastomotic strictures in children and Young adults: Original research. Radiology Volume 271: Number-2:596-601..

SECTION 1- GENERAL DETAILS

1.NAME:

2.CR No:

3.AGE:

4.SEX:

5.ADDRESS:

6.Mobile No:

7.Father’s Name:

8. Father’s Occupation

9. Socioeconomic Status (Modified Kuppusamy scale)

SECTION 2- CLINICAL DETAILS

1.History-

Birth Order

Dysphagia- Onset, grade of dysphagia, duration

History of aspiration/coughing during feeding

Surgical details- Timing of surgery

                            Place of surgery

                            Post-operative complications such as leak

                            Type of esophageal atresia

3. Anthropometry

a)         Weight:

b)         Height:

c)         Head circumference:

4.Vitals

a)         Heart Rate

b)         Respiratory rate

c)         Temp

d)         BP

5.Examination

a)         General examination 

b)         Systemic Examination

6. Diagnosis

Section 3- ASSESSMENT

Contrast esophagogram :                                 

Endoscopy:                                               

Section 4: Procedure details by date