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Medium-term Outcome of Endoluminal Gastroplication With the EndoCinch Device in Children

Thomson, Mike*; Antao, Brice*; Hall, Sharon; Afzal, Nadeem; Hurlstone, Paul; Swain, C Paul§; Fritscher-Ravens, Annette§

Journal of Pediatric Gastroenterology & Nutrition: February 2008 - Volume 46 - Issue 2 - p 172–177
doi: 10.1097/MPG.0b013e31814d4de1
Original Articles: Gastroenterology

Objective: Endoluminal gastroplication (EG) is emerging as a minimally invasive procedure for the treatment of gastroesophageal reflux disease (GERD). The aim of this study is to evaluate the medium-term outcomes after EG in a pediatric patient population.

Patients and Methods: Seventeen children with a median age of 12.4 years (range 6.1–15.9 years) with GERD underwent EG using a flexible endoscopic sewing device (EndoCinch) over a period of 3 years. Three plications were placed in the gastric tissue below the lower esophageal sphincter. Drug dose requirement, pH measurements, symptom severity and frequency, and validated Quality of Life in Reflux and Dyspepsia (QOLRAD) scores were compared before EG and 1 and 3 years after EG. Statistical analysis was performed using a Wilcoxon rank-sum test and P < 0.05 was the threshold for significance.

Results: All patients showed an immediate posttreatment improvement in symptom severity, symptom frequency, and quality of life scores. Completed 1- and 3-year data were obtained from 16 patients. Four cases (25%) required a repeat procedure as a result of recurrence of symptoms after 2 to 24 months. Fourteen patients (88%) at 1 year and 9 patients (56%) at 3 years remained without a need for any antireflux medication. A sustained improvement in heartburn (P = 0.004), regurgitation (P = 0.017), and vomiting (P = 0.018) was seen at 3 years. The total QOLRAD score (maximum of 175) improved from a median of 87 (range 69–142) to 156 (range 111–175) at 1 year (P < 0.0001) and 153.5 (range 55–174) at 3 years (P = 0.002).

Conclusions: EG is an effective and safe procedure in children. It is a viable option for the treatment of GERD refractory to or dependent on antireflux medications.

*Centre for Paediatric Gastroenterology, Sheffield Children's Hospital, UK

Hallamshire National Health Service Trust, Sheffield, UK

Royal Free Hospital, UK

§Royal London and St. Bartholomew's Hospitals National Health Service Trust, London, UK

Received 14 November, 2006

Accepted 4 July, 2007

Address correspondence and reprint requests to Mike Thomson, MD, Centre for Paediatric Gastroenterology, Sheffield Children's Hospital, Western Bank, Sheffield S10 2TH (e-mail: mike.thomson@sch.nhs.uk).

The authors report no conflicts of interest.

Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal disorders in Western populations with approximately 15% to 25% of adults experiencing reflux symptoms, mainly heartburn and/or regurgitation (1). It is also a common problem encountered in pediatric practice. The gold standard of medical and surgical management has been with the use of antisecretory medications such as proton pump inhibitors (PPIs) and antireflux surgery such as Nissen fundoplication. None of the medical therapy targets the primary mechanism of gastroesophageal reflux, namely transient relaxation of the lower esophageal sphincter. Medical therapy does not restore the antireflux barrier, and lifelong medications are often necessary. A significant proportion of children experience volume reflux and PPIs are not particularly effective in these cases. Most patients with GERD symptoms, regardless of the presence or absence of esophagitis, experience a chronic relapsing course of disease, with ≥50% continuing to receive medical therapy at 3 years of follow-up (2). In children, lack of response to PPIs can commonly be caused by inadequate dosing or the patient's not taking medication. This can be a challenging problem, especially in children because a result of lack of compliance and relapse rates as high as 82% have been reported beyond 6 months after cessation of therapy (3).

Laparoscopic Nissen fundoplication has emerged as a minimally invasive antireflux procedure with a positive outcome in >90% of patients (4–6). However, it can be associated with severe distressing symptoms such as dysphagia, inability to belch, diarrhea, and gas bloat (7,8). In cases that relapse, a repeated procedure can be technically challenging as a result of adhesions from previous surgery. In an attempt to minimize these limitations, more recently another class of minimally invasive treatments using flexible endoscopes have been developed (9). Most of the experience with endoscopic treatment of GERD has been gained in older patients. The authors have previously reported their initial experience in the use of endoscopic gastroplication in children, with a good short-term result (10). The aim of this study was to evaluate medium-term effect of endoluminal gastroplication (EG) in the treatment of GERD in the pediatric age group.

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PATIENTS AND METHODS

Between 2000 and 2003, 17 children (12 female) with established GERD underwent EG at a median age of 12.6 years (range 6.5–15.9 years). All 17 children who underwent the EG procedure were in neurologically normal condition. Their median weight was 46 kg (range 16.5–87.5 kg). No patients had a hiatal hernia on barium swallow and all of them had normal gastric emptying for liquid and solid phases. In addition, 3 patients had an esophageal motility and manometry study, which had normal findings. Ethical approval was obtained from the local ethics committee and data were collected prospectively as a part of a preestablished study protocol.

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Patient Selection

All of the patients and parents were given the choice of an endoscopic or laparoscopic/open Nissen fundoplication after a rigorous informed consent procedure. All elected and consented to the endoscopic procedure. Inclusion criteria were symptoms significantly interfering with lifestyle with or without complications of gastroesophageal reflux like hemorrhage, failure to thrive, and significant respiratory distress, and symptoms refractory to or dependent for >12 months with optimum medical management with PPIs and propulsion agents. In addition, the patients had established gastroesophageal reflux on 24-hour pH monitoring (ie, reflux index >6) and/or endoscopic/histological evidence of esophagitis. Exclusion criteria were allergic/eosinophilic esophagitis, presence of esophageal strictures or hiatus hernia >2 cm on barium swallow examination, and history suggestive of esophageal dysmotility or evidence on barium swallow.

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Endoscopic Gastroplication Procedure

This procedure was done under general anesthesia with the patient in left lateral position. The Bard Endoscopic Suturing System (EndoCinch; Bard Endoscopic Technologies, Billerica, MA) was used to perform the EG. This device was mounted on the tip of an endoscope and was used to place 3 pairs of stitches below the gastroesophageal junction (GEJ) to create 3 internal plications of the stomach (9,11–13). A fold of tissue 0.5 cm below the GEJ on the lesser curvature was sucked into the suturing capsule and a needle with the suture passed through the mucosa, completing the first plication. Two further plications were placed 1.5 cm below the GEJ on the lesser and greater curvatures in a similar fashion. This differs from reported adult series that describe various combinations of plications.

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Postprocedural Care

After the procedure, a liquid diet and ondansetron to prevent postanesthetic emesis was commenced for the first 24 h. Subsequently, a pureed diet was advised for ≥3 weeks. Antireflux medications were gradually stopped over the subsequent 1 to 2 weeks as tolerated.

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Clinical Assessment

A record of symptom frequency and severity scores, QOLRAD scores, and daily medications (in milligrams per day) was maintained for 6 weeks before and at 1 and 3 years after the procedure together with any complications of EG. The follow-up data were collected through direct consultations or by telephone interviews with patients and parents after informed verbal consent. In addition, a pH study was performed before and at 6 weeks and when agreed to at 1 year after the procedure. Reflux index was calculated based on the percentage of time with a pH <4.

Clinical success was defined as a reduction/cessation of symptoms and medications, whereas failure of resolution of initial symptoms or recurrence after resolution within 12 months was considered as a failure of the procedure.

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Statistical Analysis

Statistical analysis was done using SPSS software (version 12.0.1; SPSS, Chicago). Data are presented as medians and interquartile ranges. Comparative data were analyzed using the Wilcoxon rank-sum test. Box and Whisker plots with median and interquartile ranges were used to demonstrate any trends. P < 0.05 was considered significant.

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RESULTS

The results of the endoscopic assessment are summarized in Table 1. The first 5 patients had 2 gastroplications inserted longitudinally 0.5 cm and 1.5 cm below the GEJ. Three of these required a second gastroplication procedure 8 to 12 weeks after the first as a result of symptomatic failure. At endoscopy, it was noted that one of the plications had failed in each case. Hence, subsequently, 3 plications were inserted with good results. In addition a third procedure was required in 1 patient, and another patient with recurrent symptoms underwent a second EG procedure within 2 years of the first with good symptom control. The median procedure time from instrument insertion to removal was 65 (range 54–126) minutes. Complete 1- and 3-year follow-up data were obtained for 16 patients. The oldest patient (21 years) was lost to follow-up.

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Complications of the Procedure

Immediately postprocedure, transient complaints such as sore throat and minor epigastric pain occurred. Two patients developed retrosternal chest pain and 3 postoperative nausea and vomiting. All of these complaints resolved spontaneously within 24 h. One patient, who was subsequently diagnosed to have a platelet pool storage disorder, developed transient bleeding from the site of plication requiring a packed red cell transfusion. No adverse events such as dysphagia or inability to burp were reported at 3 years follow-up.

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Postprocedural Assessments

All of the patients showed a postprocedural improvement in symptom severity, frequency, and quality of life scores.

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Symptom Analysis

There was a significant improvement in heartburn frequency and severity (P = 0.03 and P = 0.022, respectively), regurgitation frequency and severity (P = 0.003 and P = 0.033, respectively), and nausea frequency and severity (P = 0.003 and P = 0.039, respectively) at 1 year. The improvement in regurgitation frequency (P = 0.017) and heartburn frequency and index (P = 0.004 and P = 0.004, respectively) was sustained at 3 years after the procedure. In those patients in whom vomiting was present, there was a significant improvement in frequency and severity (P = 0.018 and P = 0.018, respectively) at 3 years (Fig. 1).

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Quality of Life Assessment

Median QOLRAD scores demonstrated a statistically significant improvement at 1 year (P < 0.001), with a sustained improvement at 3 years follow-up (P = 0.002). The subsections of QOLRAD that showed a significant sustained improvement at 3 years were vitality, physical/social functioning, food and drink problems, and emotional distress. Total QOLRAD score (maximum of 175) increased from a median of 87 (range 69–142) to 156 (range 111–175) at 1 year (P < 0.001) and was sustained at a median score of 153 (range 55–174) at 3 years (P = 0.002; Fig. 2). The pre-EG scores were recorded with all patients receiving treatment, whereas the post-EG scores were recorded with all patients not receiving treatment at 1 years in 15 patients and at 3 years in 9 patients.

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Twenty-four-hour pH Monitoring

Assessment of acid gastroesophageal reflux by 24-hour ambulant pH analysis was done before and at 6 weeks after the procedure in 16 patients and at 1 year in 9 patients. The parents of the remaining patients declined a repeat study as a result of excellent control of symptoms after the procedure at that time. In the remaining cases, the parameters compared were reflux index, upright and supine reflux index, number of reflux events per hour, number of reflux events longer than 5 min in duration per 24-hour study, and DeMeester score. All pH parameters improved after treatment (Table 2). Although no routine upper endoscopic follow-up was done, in 5 cases that had repeat gastroplication, a histological improvement of esophagitis was demonstrated.

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Use of Antireflux Drugs

Before the procedure, all patients were dependent on antisecretory therapy. Fourteen patients at 1 year (88%) and 9 patients at 3 years (56%) remained off all antireflux medications. The median dose of PPI was reduced from 39.9 mg/day (range 13.8–60.6 mg/day) before EG to zero (range 0–50 mg/day) at 3 years (P = 0.003). Five patients had good symptom control with only occasional doses of PPI and 2 had returned to regular PPI use. In addition, 10 patients were receiving domperidone and 5 were receiving cisapride before EG. At 3 years follow-up only 6 patients (60%) continued to used domperidone and no patients were taking cisapride. Discontinuation of cisapride was a result of its withdrawal from the market by the manufacturers, and was not considered as an outcome measure.

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DISCUSSION

Endoscopic gastroplication using the EndoCinch endoscopic suturing device was developed by Swain and colleagues (14). The basis of this procedure is to construct plications in the gastric mucosa/submucosa below the lower esophageal sphincter with the intent to improve its function by augmenting the antireflux barrier (15). It is shown to reduce transient lower esophageal sphincter relaxations and slightly increase lower esophageal sphincter pressure (16). This procedure has been used in adults for the treatment of GERD, in which several studies have shown it to be a safe and effective procedure with a good short-term outcome. However, there are some concerns about its medium- to long-term efficacy in the treatment of GERD (17–21).

Our initial results in children suggested that EG was a safe procedure that was able to improve the quality of life and symptoms in cases of GERD in the short term (10). Other studies in adult patients have shown posttreatment improvement in symptom severity, frequency, and QOLRAD scores as well (22,23), but no long-term data are available for children. However, because there are no similar assessment tools in children and the questions were easily comprehensible to our patients, this same scoring system was used to “semiquantify” reflux-related quality of life. There was a significant improvement in frequency and severity of heartburn, vomiting, and regurgitation after EG (10), and these improvements were sustained even at 3 years of follow-up in 56% of the 16 children. There was also a sustained improvement in quality of life scores at 1 year and 3 years after treatment. There was an objective improvement in the pH parameters at 1 year of follow-up (Table 2). All but 2 cases had a reflux index of >6. In the 2 cases that had indexes of <6, significant symptoms interfered with their lifestyle and were refractory to antireflux medications for >12 months with endoscopic/histological evidence of esophagitis.

Although no routine endoscopic follow-up was arranged because the procedure requires general anesthesia in children, there was a histological improvement of esophagitis seen in all 5 cases that required a repeat procedure even 2 years after EG. Although the number of patients who were not taking antireflux medications decreased from 88% at 1 year to 56% at 3 years, good symptom control was achieved in the remainder with a dosage reduction or occasional use of PPI that previously failed to provide symptomatic relief. After workup of the patients with repeat procedures, there was a coincidence of return of symptoms with vomiting episodes after a viral illness or postanesthetic illness for another unrelated procedure in all of them. Although the 3-year results have shown that only 56% of children remained symptom free and 25% needed a repeat procedure, these results represent a better outcome than those seen with medical treatment alone. Also, because the procedure is reversible, it does not have the potential complication rate of Nissen fundoplication, and children, who still grow, may benefit from not having surgery. It is a matter of debate whether dependency on long-term medical antireflux therapy constitutes an indication for an antireflux procedure. The 9 children in this series who had effective symptom control with medical management have been receiving optimal dosages of PPIs for >1 year. The parents made an active decision that they did not want their children to remain on long-term medications and elected for them to undergo this procedure. At 3 years after EG, 6 of these patients remained off all antireflux medications, and in the other 3, good symptom control was achieved with occasional use of PPIs, which previously had failed to control symptoms.

In adults, EG is routinely carried out as a day case procedure under sedation, whereas all of our children were treated under general anesthesia and most had an overnight stay, as the pediatric age group would have a different feel for trauma than adults, which requires special attention. Various combinations of plications, such as 2 circumferential or 2 to 3 longitudinal plications, have been described in studies in adult patients (17–20). In our study, another slightly different approach was used with 1 plication 0.5 cm below the GEJ on the lesser curvature and 1 or 2 plications 1.5 cm below the GEJ on the lesser and greater curvature. To date, there is no proof that any configuration of sutures would obtain better outcomes than others (19). One main cause of failure of EG has been loss of suture (20,21). This could be related to the device, which is designed to deploy sutures to a depth not exceeding the muscularis propria, but may also be related to inadequate suction on the device cavity, which results in an inadequate amount of tissue captured within. If the subsequent sutures are not deep enough and stay, for instance, within the mucosa, then they may easily fall out. It has been recommended that ≥3 sutures be used for this procedure (24). Three of the 5 patients in our cohort who had 2 plications required repeat EG, at which time the loss of one suture was seen. Since then, it has been our practice to routinely use 3 sutures, which has resulted in good outcomes.

Although there has been no single factor identified that can predict outcome after EG (19), short-term and medium-term outcomes in children have been demonstrated by our series to be more promising than outcomes in adults. The possible explanation for this could be related to a slight anatomic difference of the GEJ and pathogenesis of GERD in children or a relative greater depth of plications to esophageal wall thickness in children versus adults (10,25).

Our study has shown that EG is a safe, minimally invasive procedure in the management of GERD in children. There were no complications related to the procedure in our study. There have been reports of complications such as mucosal tear, suture perforation, and bleeding, all of which were self-limiting (26). EG produces short- and medium-term sustained improvement in symptoms and quality of life, reducing the need for lifelong medications on a regular basis. Because of the various limitations of other methods of treatment of GERD, EG is a viable option for the treatment of GERD in children. Its safety, reversibility, and efficacy make this novel procedure especially valuable in children.

Like any new technology, surgeons may be faced with a learning curve. However, no advanced endoscopic skills are necessary, and our experience indicates that it is easy to progress on the learning curve. In a selected group of children with GERD refractory to or requiring continuous antireflux medication, EG is worth considering as a first-line surgical treatment, and in case of failure, the option of repeat EG or other more invasive antireflux procedures still remains. However, further and larger studies are necessary to ascertain its efficacy.

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Keywords:

EndoCinch device; Endoscopic antireflux therapy; Gastroesophageal reflux disease

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