Balloon dilation therapy for managing anastomotic strictures subsequent to surgical correction of esophageal atresia

Introduction

Esophageal atresia (EA) is a serious congenital malformation of the gastrointestinal tract, which can be isolated or part of a syndrome (like VACTERL). Its cure rate has increased in recent years due to the improvements in early diagnosis, neonatal anesthesia, and surgery, and the enhancement of perioperative monitoring and nutritional support (1). However, there are still challenges and controversies surrounding the treatment of cases involving other complex malformations, an extended EA gap, and low weight. At the same time, postoperative complications are numerous and complicated, and postoperative management remains a crucial and challenging issue for clinicians (2).

Short-term postoperative complications such as anastomotic leakage and sepsis are often responsive to conservative treatment. In contrast, medium-term complications, such as feeding difficulties, recurrent tracheoesophageal fistulas (TEFs), esophageal strictures, gastroesophageal reflux, and respiratory diseases, require ongoing monitoring into adulthood (3). The prevalence of postoperative anastomotic leakage is reported to be between 15% and 20%, with approximately one-third of children experiencing severe postoperative complications affected by this issue (4,5). Notably, 95% of cases with early anastomotic leakage resolve spontaneously, with the majority undergoing self-repair and only a minority necessitating surgical intervention. However, over 50% of these cases may progress to esophageal strictures (6), of which approximately 70% require esophageal dilation (7,8). In ESPGHAN-NASPGHAN guidelines, no controlled studies compare hydrostatic balloon or a semi-rigid dilator for treatment of Anastomotic strictures (AS) in EA patients. No evidence has been reported of increased effectiveness or safety for one or the other dilator type. It also suggests dilation must be carried out using the technique with which the operator is most skilled and experienced (9). This paper summarizes the experiences of managing children who underwent balloon dilation for the treatment of AS following surgical repair of EA at two leading medical centers over the last two decades. We present this article in accordance with the SUPER and STROCSS reporting checklists (available at https://tp.amegroups.com/article/view/10.21037/tp-2024-572/rc).

Methods

Clinical data

This retrospective study included a cohort of 31 children, composed of 21 males (67.7%) and 10 females (32.3%), all aged between 0 to 1 year, who underwent balloon dilation for AS following surgical repair of EA from October 1995 to October 2022. There were 3 cases of I, 9 cases of IIIA, 12 cases of IIIB, 1 case of V, and 6 cases were born and operated in other medical institutions. This procedure was conducted at two medical centers: Shanghai General Hospital and Xinhua Hospital. The pediatric patients were categorized into two age groups: less than 6 months old and equal or older than 6 months. All of them received an open correction. Anastomotic leaks were observed in approximately 12.9% of patients (4/31). This study was conducted with approval from the Ethics Committee of Shanghai General Hospital (No. 2023SQ142) and Xinhua Hospital (No. WHEC-C-2023-010-1). This retrospective cohort study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. Written informed consent was obtained from all patients’ guardians.

In our clinical practice, it was observed that younger children required balloon dilations less frequently, a finding supported by existing literature (10), which noted a lower frequency of dilations in children under 6 months compared to their older counterparts. This observation led us to adopt this specific age threshold in our study, facilitating a targeted approach to treatment and follow-up based on the distinct needs of these age groups.

Preoperative preparation

Each dilation was preceded by a barium swallow examination of the esophagus or digital subtraction angiography (DSA)-assisted esophagography to determine the site, extent, and degree of the esophageal stricture. At the same time, the presence of recurrent TEFs and esophagitis in children was determined before balloon dilation from clinical symptoms, with endoscopy employed for determining local inflammation when deemed necessary. Balloon dilation procedures were deferred for children diagnosed with TEF and severe esophagitis, opting instead for conservative treatment to reduce local inflammation prior to any interventional procedure.

The status of esophagitis was confirmed via endoscopic examination to reduce the potential risks associated with radiation exposure. Despite the challenges posed by esophageal stenosis, which significantly affects the quality of life in affected children, measures were implemented to minimize radiation exposure during balloon dilation procedures and to ensure rigorous post-procedural follow-up.

Follow-up assessments were conducted between 3 to 6 months post-procedure, focusing on the evaluation of symptoms and growth curve changes. Upon manifestation of symptoms such as dysphagia, milk aspiration, food impaction, or inadequate weight gain and subsequent confirmation of esophageal stenosis through esophageal barium meal examination or DSA-assisted esophagography, diagnostic and management measures were initiated for postoperative stenosis. This paper specifically encompasses those pediatric cases definitively diagnosed with postoperative stenosis.

Balloon dilation

A Flourish™ catheter (Cook^®, Bloomington, USA) with a balloon diameter of 6 to 15 mm was used for balloon dilation. Initially, a balloon 2 to 3 mm larger than the internal diameter of the stricture segment was selected for dilation. During the procedure, the child was positioned supine on the operating table, and anesthesia was administered by an anesthesiologist. Two radiologists, with the assistance of a surgeon, performed the balloon dilation under X-ray fluoroscopy. The guidewire was first inserted through the mouth into the stomach, followed by the placement and securing of the balloon at the esophageal stricture via the dilation catheter (Figure 1).

Figure 1 Esophagography before balloon dilation.

After removing the guidewire, 20% diatrizoate meglumine was injected into the balloon via the catheter using a 20 mL syringe. The pressure was gradually increased from approximately 0.5 atm to 3 atm and maintained for 3 minutes. During this process, the constricted segment of the esophagus, initially appearing as a “waist” on the balloon, progressively diminished and eventually disappeared. Afterward, the contrast material was quickly withdrawn to deflate the balloon. The procedure included three consecutive dilation sessions, each involving balloon inflation for 3 minutes, with the expansion pressure documented and the subsequent inflation performed after a half-minute interval.

Post-dilation, esophagography was performed using 30% diatrizoate meglumine to observe the immediate efficacy of dilation and ascertain the presence of complications such as esophageal rupture. The duration of the procedure was approximately half an hour. Afterward, children were transferred to the ward for postoperative observation until they awoke.

Dietary management post-procedure involved providing a semi-liquid diet 24 hours after dilation, followed by a transition to a normal diet 48 hours later. Evaluation of the esophageal stricture segment was conducted via barium swallow examination, or DSA-assisted esophagography at 1 week and 1 month post-dilation. The success of the procedure was determined immediately after dilation using esophagography with 30% meglumine diatrizoate. Instances where the procedure failed or could not be completed were classified as unsuccessful outcomes.

Balloon dilation of the esophagus was performed under intravenous combined anesthesia without tracheal intubation. If a child exhibited intolerance to anesthesia or procedural failures, the operation was discontinued. Three to six months following the procedure, the dietary progression from liquid to semi-liquid and then to solid food was monitored. Clinical improvement was assessed based on symptom relief such as reduced vomiting and notable weight gain, while persistent dysphagia or ongoing stenosis on esophagography indicated a lack of treatment efficacy.

After each balloon dilation session, which was conducted three times for 3 minutes each, the dilation pressure was recorded, and the subsequent dilation was initiated after a half-minute interval. Immediately following the dilation procedures, esophagography using 30% meglumine diatrizoate was performed to assess the immediate effectiveness of the dilation. Cases where procedural difficulties were encountered or complete expansion of the balloon was not achieved were classified as unsuccessful.

In situations where balloon expansion failed to achieve the desired result, a conservative management approach was initially adopted. After a recovery period, the patient was reassessed 1 month later. Depending on the outcome of this assessment, further balloon dilations were scheduled at appropriate intervals until clinical recovery was achieved. Alongside these interventions, dietary adjustments were made to facilitate recovery, beginning with liquids and gradually progressing to semi-liquid and then solid foods. Additional supportive measures included positional adjustments during meals and the administration of topical anti-inflammatory treatments, such as proton pump inhibitors (PPIs), as required.

Esophagitis, a common complication in these cases, was successfully alleviated and cured in all children through conservative treatment. Following the surgery, a structured dietary regimen was implemented, starting with liquids and systematically advancing to solid foods, to support the healing process and promote optimal recovery.

Efficacy evaluation

The short-term effect of dilation was assessed using esophagography, and its impact was determined by monitoring the improvement in feeding and weight gain in children. Effective treatment consisted of a transition from a liquid diet to a semi-liquid diet and then to solid food, alleviation of vomiting, and significant weight gain. The determination of significant weight gain was based on the actual growth curve of the child, whereby achievement equal to or surpassing the predicted growth curve was deemed indicative of significant weight gain. This follow-up was conducted over a period of 3 to 6 months.

In cases where treatment was deemed ineffective, characterized by persistent dysphagia and the visualization of the stricture segment on esophagography, additional balloon dilations were performed for affected children, and continuous follow-up was maintained. Currently, the assessment of whether gastroesophageal reflux is present is still based on endoscopic examination, guided by the clinical symptoms observed in the children.

Following the surgical repair of EA/TEF, a comprehensive follow-up protocol was implemented for all patients. This included monitoring not only the symptoms and signs associated with postoperative complications but also tracking growth curves to assess overall health and development. Should symptoms such as dysphagia, milk aspiration, food impaction, or inadequate weight gain occur, coupled with the confirmation of esophageal stenosis through esophageal barium meal examination or DSA-assisted esophagography, targeted diagnostic and therapeutic interventions for postoperative stenosis were initiated. It is important to note that this paper specifically addresses cases in children who have been definitively diagnosed with postoperative stenosis.

Statistical analysis

Statistical software (IBM SPSS Statistics 19) was used for data analysis. The Chi-squared test was used for comparisons between two groups. P<0.05 was considered a statistically significant difference.

Results

This study encompassed 31 children, including 21 males (67.7%) and 10 females (32.3%), all aged between 0 and 1 year. A total of 86 balloon dilations were performed on these children, with 78 procedures deemed successful, resulting in a success rate of 90.7%. In addition, 13 children underwent DSA-assisted balloon dilations. Four children experienced restenosis, and 1 child suffered from esophageal peroration after the initial dilation. At the 3–6-month follow-up, the treatment was effective in 26 children, with an overall effective rate of 84%.

The children were grouped according to age, and then statistical analysis was performed. Specifically, 21 children were aged younger than 6 months, and 10 children were aged equal or older than 6 months. The analysis revealed no significant difference in the severity of esophageal strictures between these age groups. However, the younger group required significantly fewer dilations (1.5 times per patient, 32 dilations across 21 cases) compared to the older group (5.4 per patient, 54 dilations across 10 cases), with a statistical significance (P<0.05). The recovery rate between the two groups did not show a significant difference (P>0.05), as summarized in Table 1.

Of the 86 dilations, eight were unsuccessful, primarily due to respiratory distress caused by airway compression during the procedure, which occurred in six cases. This distress led to the cessation of the dilation. The remaining two unsuccessful cases were due to inadequate balloon fixation at the stenosis site, causing multiple slips and subsequent dilation failure.

Following an incident of esophageal perforation, one child required a repeat esophageal repair procedure. About 50% of the participants had gastroesophageal reflux and were treated with PPIs. Currently, the diagnosis of gastroesophageal reflux relies on clinical symptoms, with 24-hour esophageal pH monitoring not yet being a standard practice. The condition of the airway and the recovery status of the stenosis are critical factors influencing the surgical procedure and prognosis. Anastomotic leaks were observed in approximately 12.9% of patients (4/31).

Discussion

AS following surgical repair of EA are the most common cause of pediatric esophageal strictures, with balloon dilation being the preferred treatment modality (4). After EA repair, the need for multiple dilations is often due to the formation of dense, fibrous scars over time. Consequently, early detection of AS and timely balloon dilation before significant scar formation can enhance the success rate of the procedure.

It is critical to note that the anastomosis site typically has not fully healed within 3 weeks post-esophageal surgery. Performing balloon dilation too soon can lead to complications such as esophageal perforation (11,12), which has a reported incidence of 0–2.7%, particularly elevated in children with gastroesophageal reflux (11). Recommendations to minimize the risk of esophageal perforation and rupture during balloon dilation include using a balloon longer than the stricture segment, selecting a balloon diameter that matches the width of the structured esophagus and can be gradually increased, achieving the normal width of the esophagus through multiple dilations, spacing dilation sessions at least 1 week apart, and limiting balloon pressure to no more than 3 atmospheres (12).

However, in our experience, the use of a balloon with a diameter as close as possible to the normal esophageal width improves the efficacy of balloon dilation without increasing the risk of complications of esophageal perforation. A critical factor in this process is the careful selection of candidates for dilation, particularly avoiding children with severe esophagitis and gastroesophageal reflux.

Moreover, it has been observed that younger children, specifically those under 6 months, require fewer balloon dilations compared to older children (12). In our study, the mean number of balloon dilations for children younger than 6 months was 1.5 times per case (32 times across 21 cases), which was significantly lower than the mean of 5.4 times per case (54 times across 10 cases) for children equal or older than 6 months. Despite these differences in the number of procedures required, the recovery rates between the two age groups did not show substantial variance.

In our study, restenosis after balloon dilation was observed in four children. Two of these cases were identified through barium swallow examinations during follow-up and successfully treated with re-dilation. However, in the remaining two cases, re-dilation proved ineffective due to the excessively long follow-up interval of 4 months. This suggests that re-stenosis can reduce the therapeutic effect of initial dilation, and it highlights the importance of a structured follow-up regime. Monthly follow-ups for the first 3 months post-procedure are crucial for evaluating the improvement of AS and for timely re-dilation if necessary.

The five cases of ineffective treatment in our study were attributed to factors such as excessive stricture severity, prolonged postoperative stricture formation, and restenosis following an initial dilation with an extended follow-up period.

Additionally, the vital signs of children should be closely monitored during balloon dilation. If dyspnea develops, the balloon pressure should be promptly released to relieve the pressure on the airway, and a tracheal cannula should be inserted if necessary. Postoperative pulmonary symptoms in children should also be closely monitored (13). For instance, one child in our study exhibited severe post-dilation symptoms, including high fever, cough, expectoration, asthma-like dyspnea, and additional complications the night following the procedure. This child was promptly made to fast, underwent gastrointestinal decompression, and was later diagnosed with an esophageal rupture, severe pneumonia, and a mediastinal abscess. Treatment included bilateral closed-chest drainage and irrigation, along with the long-term retention of a nasojejunal feeding tube, which led to gradual improvement in the child’s condition. Longer follow up studies are needed in the future.

The timing and method of surgical interventions vary according to the specific subtype of EA, which in turn influences the scheduling of postoperative balloon dilations. Our data suggest that children who underwent earlier balloon dilations generally required fewer subsequent treatments, likely due to the less severe pathology in those eligible for earlier intervention.

It is important to note that our retrospective study has a limited sample size. More multi-center studies can help us to compare the two dilatation strategies better. In addition, DSA could result in more radiation exposure than conventional X-ray, so further research is needed to investigate its safety profile in the target population. To obtain more comprehensive insights and validate the effectiveness of DSA in this context, future research should aim for larger sample sizes, incorporate multi-center collaborations, and utilize prospective study designs.

Conclusions

Since 2012, DSA technology has been used to assist in esophagography and balloon dilation in conjunction with a variety of guidewires, catheters, and auxiliary devices. This method not only takes advantage of the precise positioning of conventional X-ray catheterization, but it also overcomes the technical challenges associated with this type of catheterization, thus elevating the success rate of one-time catheterization with minimal intraoperative reactions and a brief operation time. Additionally, the flexibility of the DSA machine allows for the C-arm to be rotated into a left anterior oblique position by 30°. This eliminates the need to reposition the patient and provides an excellent field of view, clearly displaying the structural relationship between the trachea and esophagus. Therefore, the DSA technique should be advocated in the clinical practice of balloon dilation for the treatment of AS following surgical repair of EA.

Acknowledgments

We would like to acknowledge the hard and dedicated work of all the staff that implemented the intervention and evaluation components of the study.

Footnote

Reporting Checklist: The authors have completed the SUPER and STROCSS reporting checklists. Available at https://tp.amegroups.com/article/view/10.21037/tp-2024-572/rc

Data Sharing Statement: Available at https://tp.amegroups.com/article/view/10.21037/tp-2024-572/dss

Peer Review File: Available at https://tp.amegroups.com/article/view/10.21037/tp-2024-572/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tp.amegroups.com/article/view/10.21037/tp-2024-572/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted with approval from the Ethics Committee of Shanghai General Hospital (No. 2023SQ142) and Xinhua Hospital (No. WHEC-C-2023-010-1). This retrospective cohort study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. Written informed consent was obtained from all patients’ guardians.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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