Introduction

Gastroesophageal reflux disease (GERD) is symptomatic reflux associated with sequelae. These include failing to thrive, refractory wheezing, coughing aspiration, acute life‐threatening events, apnea, chronic otitis media, sinusitis, hematemesis, anemia, esophageal strictures, and Barrett’s esophagus. A follow‐up of 126 children with GERD in infancy showed 55% were symptom free by 10 months and 81% by 18 months of age. However, those with frequent symptoms (>90 days) in the first two years of life are more likely to have symptoms by 9 years of age.

Gastroesophageal reflux treatment aims to achieve symptom relief while preventing complications. Patients who fail to achieve control with medical therapy may have persistent, severe esophagitis or become long‐term dependent on antireflux treatments. In such cases, an antireflux procedure may be indicated. The principle of surgery in GERD is to form some kind of reconstruction of the antireflux barrier, although exactly how efficacy is achieved is not fully understood. Open Nissen’s fundoplication has been the treatment of choice to date, but is invasive and associated with morbidity and mortality. In recent years, laparoscopic fundoplication has become popular and, in general, has replaced the open Nissen’s procedure, although superior efficacy and safety have yet to be demonstrated. With the laparoscopic procedure, cosmesis is clearly superior, and in adult studies complications appear less common, with good success rates. It could be argued, therefore, that there remains little or no place for open antireflux procedures in pediatrics.

Three endoscopic techniques have been devised and used for treatment of pediatric GERD. These are described below.

Endoscopic suturing devices

Endoluminal gastroplication makes use of an EndoCinch® sewing machine attached to the endoscope (gastroscope) placing three pairs of stitches below the gastroesophageal junction to create three internal plications of the stomach. Plications may be applied either circumferentially or longitudinally dependent on operator preference. The authors have a preference for placing two plications circumferentially 1.5 cm below the gastroesophageal junction and one 0.5 cm below the gastroesophageal junction, which we believe may be anatomically superior to other formations (Figure 28.1–Figure 28.4 ).

Endoluminal gastroplication is now routinely carried out as a day‐case procedure in adults. Preliminary studies have shown it to be quick, noninvasive, effective, and safe. Results are comparable to the laparoscopic fundoplication in adults, which has been studied as a preferable alternative choice to an open Nissen’s fundoplication.

Recently, the authors have reported use of EndoCinch in the treatment of 17 children (eight males, median age 12.9 years, range 6.1–17.7, median weight 45 kg, range 16.5–75) with GERD refractory to or dependent on (>12 months) proton pump inhibitors. All patients showed posttreatment improvement in symptom severity, frequency, and validated reflux‐related quality of life scores (p <0.0001) (Figure 28.5). At 36 months median follow‐u,p 11 out of 17 patients were asymptomatic and no longer taking any antireflux medications. At 12 months follow‐up, all pH parameters improved and had returned to normal in eight of nine patients who underwent pH studies (reflux index fell from 16.6% [0.9–67%] to 2.5% [0.7–15.7%], p <0.0001) (see Figure 28.5).

The duration of action is open to ongoing assessment and debate, and has not been particularly impressive in adult studies. The reasons for superior efficacy and duration in children may be conjectured and due to some or all of the following: three pairs versus two pairs of sutures; greater time and care taken by the operator allowed by general anesthetic with the added advantage of absence of movement or retching during the procedure; and lastly the relatively deeper suture depth in the thinner pediatric esophagus compared to the larger adult one. Data are now available indicating medium‐term success in terms of reflux‐related quality‐of‐life scoring at three years post EndoCinch and in terms of avoidance of PPI in the majority of patients. This is a small study but worthy of mention (Figure 28.6).

Despite the loss of sutures on observational follow‐up studies, some efficacy has been maintained, and the human and porcine endoultrasound studies of Liu et al., along with cadaveric analysis of the porcine model post EndoCinch, may throw some light on this observation. They suggest that the tissue remodeling in response to the foreign body, which is the suture, resulting in significant hypertrophy of the circular muscle layer of the esophagus may be the reason.

Nevertheless, EndoCinch has not maintained its initial enthusiastic uptake, and has been recently superseded by the next generation of full‐thickness gastroplication transoral endoscopic techniques.

The next technique to appear was the Full‐Thickness Plicator® (Ndo‐Surgical). This is placed under direct vision with a neonatal size endoscope passed through a specially designed endoscopic delivery system with an outer diameter of more than 20 mm. The retroflexion of both allows observation firstly of the opening of the jaws of the device, followed by the insertion of the corkscrew into the fundal tissue, allowing capture of the fundus and withdrawal into the jaws which are then closed. A pretied full‐thickness plication is then applied by the mechanism of shutting the jaws and a serosa‐to‐serosa plication is made (Figures 28.7–Figures 28.9 ). A multicenter adult study has shown acceptable efficacy and a reduction of PPI requirement in a small adult cohort, but further study is necessary before this can be applied to children – the device is size and age constrained due to its large outer diameter.

EsophyX ®

This device is an alternative to the plicator technology along a similar theme, although not identical.

The novel Transoral Incisionless Fundoplication (TIF)® procedure using EsophyX (Texas Laparoscopic Consultants) mimics antireflux surgery in constructing an anterior partial fundoplication with tailored delivery of multiple fasteners during a single‐device insertion (Figures 28.10 and 28.11). The TIF procedure was designed to restore the antireflux competency of the gastroesophageal junction by reducing small hiatal hernias, increasing LES resting pressure, narrowing the cardia, and recreation of the acute angle of His.

A feasibility study was started in December 2008 after obtaining appropriate training in the use of the EsophyX device in its second iteration – the so‐called TIF2 procedure. The feasibility study was conducted with 12 children (eight male) with a median age of 12.25 years (range 8–18) years and weight of 38.2 kg (range 26–91). The median duration of GERD symptoms was 45 months (range 24–70) and all subjects were on GERD medication for more than six months. The median pre‐TIF2 reflux index off treatment was 11.4% (range 6–48%). Hiatus hernia was present in 17% (2/12). Median operative time was 42 minutes (range 25–94). Adverse events were experienced by three subjects and consisted of mild or moderate pharyngeal irritation and epigastric pain. Two of the three subjects also had retrosternal chest pain and were subsequently found to have pneumomediastinum on CT chest but no leak on barium swallow. One of these two patients had pyrexia accompanying chest pain and was treated for possible mediastinitis and discharged home after five days of intravenous antibiotics. Subsequently, CO₂ insufflation was employed and more rapid absorption resulted in no further periprocedure mediastinal gas leak.

At six‐month follow‐up, all subjects (n = 10) discontinued PPIs, 80% were asymptomatic and 70% had normalized or clinically significantly reduced reflux index (10% time pH <4). The results of this feasibility study showed that the TIF procedure was feasible, safe (with CO₂ insufflation) and clinically effective in treating GERD in children. Ongoing studies are occurring. Furthermore, the speed of the procedure, the days of hospitalization, the relative cost‐efficacy, and cost–benefit are identified in Figures 28.12–Figures 28.14.

Delivery of radiofrequency energy (Stretta® system)

The Stretta system has two parts – a catheter and a control module. The Stretta catheter is a flexible, hand‐held, single patient‐use device that delivers radiofrequency energy generated by the control module (Figure 28.15). It is inserted into the patient’s mouth and advanced to the gastroesophageal junction. A balloon is inflated and needle electrodes are deployed into the tissue. Radiofrequency energy is delivered through the electrodes to create thermal lesions in the muscle of the lower esophageal sphincter and gastric cardia. As these lesions heal, the tissue contracts, resulting in a reduction of reflux episodes with improvement in symptoms. The Stretta control module delivers this radiofrequency while, at the same time, providing feedback to the physician regarding treatment temperatures, tissue impedance values, elapsed time, catheter position measurement, and irrigation rate.

This treatment has been used in adults since 1999. Complications are rare but among those reported are ulcerative esophagitis with gastroparesis, esophageal perforation, and a case of aspiration following the procedure. Short‐term (one year) success was reported in an open‐label trial. In a prospective study (nonrandomized controlled trial) of 75 patients (age 49 +/− 14 years, 44% male, 56% female) undergoing laparoscopic fundoplication and 65 patient (age 46 +/− 12 years, 42%, 58% female) using the Stretta procedure, at six months 58% of Stretta patients were off PPIs and an additional 31% had reduced their dose significantly. In comparison, 97% of laparoscopic fundoplication patients were off PPIs. With long‐term follow‐up of the patients receiving the Stretta treatment, beyond two years, 56% had discontinued use of all antisecretory drugs.

This treatment has been reported in an uncontrolled study of eight children with a variable follow‐up period of 5–15 months. It was reported that six of eight children improved, and the cohort included three neurologically impaired children who also had concomitant PEG placement. One of this group had a postprocedure aspiration which was successfully treated. Of the two failures, one remained dependent on PPI and the other had a successful Nissen’s fundoplication.

Pediatric gastroenterologists may be guarded in using this form of treatment as clearly, using thermal energy treatment in a 70 year old is different from using it in a child who may have unknown consequences in the long term. With the more recent and probably safer iterations of this technique, there are a number of studies occurring in pediatrics and these may provide positive results in due course.

Gastroesophageal biopolymer injection

In the Enteryx® (Boston Scientific) procedure, a liquid polymer is injected into the lower esophageal sphincter with a needle catheter via an endoscope. After the injection, the polymer solidifies into a sponge‐like permanent implant. This improves the gastroesophageal junction, by supporting and improving its elasticity and therefore reducing the degree of gastroesophageal reflux (Figure 28.16).

Conclusion

The most promising results seem to accrue in the mid‐term with the suturing devices which attain full‐thickness plications, increase the intraabdominal portion of the esophagus (most likely by plication tags inserting through the diaphragmatic crura as well as the full thickness of the esophageal wall, i.e., actual change in anatomy), and raised intrasphincteric length and resting pressure. Endoultrasound may provide a more controlled and sophisticated approach to this technology in the future.