Introduction

Over the last 40 years the prevalence of obesity in the pediatric population in developed countries has risen substantially. The high prevalence of obesity in children early in life causes a high incidence of serious health complications, such as diabetes mellitus, hypertension, and nonalcoholic fatty liver disease. In addition to having medical co‐morbidities, obese children can also have significant psychosocial problems. Unfortunately, a significant percentage of children with obesity will become obese adults. The combination of medical co‐morbidities and psychosocial problems significantly lowers the quality of life so optimal therapeutic modalities should be initiated early in life.

Treatment of obesity and its associated metabolic diseases requires a multidisciplinary approach, with adequate nutrition intervention, lifestyle modification, and physical exercise. However, only a small percentage of adolescents is able to be compliant with the diet and exercise in the long term. Furthermore, data available for the safety and efficacy of medications that have been studied for the treatment of obesity in children are limited. More enduring weight loss has been achieved with surgical interventions than with diet, physical activity or medications. In morbidly obese adults, Roux‐en‐Y gastric bypass, sleeve gastrectomy, and laparoscopic banding are well‐established methods of losing weight. Due to significant improvement of obesity and obesity‐related diseases, the surgical approach is becoming more popular in adolescents as well.

The surgical method most frequently used is Roux‐en‐Y gastric bypass. However, bariatric surgery is not an optimal method to treat obese children due to several reasons: irreversibility of the procedure, possible important side effects, uncertainty about long‐term outcomes, and ethical considerations related to adolescents agreeing to bariatric surgery procedures. As an alternative, a less invasive approach to treat morbidly obese adolescents is a nonsurgical endoluminal intervention performed by flexible endoscopy. Endoscopic bariatric techniques (EBTs) are safer and more cost‐effective than current surgical approaches. In the field of metabolic obesity disease in adults, several different endoscopic approaches have been described, such as endoscopic gastroplasty, intragastric balloon, endoscopically placed tube which allows aspiration therapy, endoluminal malabsorptive bariatric procedures, and gastric electrical stimulation. Occupying gastric volume, restricting gastric capacity, and reducing absorption of ingested food are the underlying mechanisms for losing weight in the EBTs.

The rest of the chapter will focus only on those EBTs that have been studied and described in children.

Intragastric balloons

The insertion of intragastric balloons involves a standard upper GI endoscopy and a catheter inserted alongside the endoscope, within which is a tethered balloon. Once in position, the balloon oversheath is withdrawn, allowing the balloon to be inflated with fluid containing methylene blue. At this point, 500 mL of fluid is injected and then the balloon is ejected from the catheter into the stomach. The balloon is left for six months and then removed using an endoscopic technique involving a hook grasping forcep and a needle to puncture the balloon, thereby aspirating the fluid and contracting the balloon; once all the fluid is withdrawn then the balloon can be extracted orally.

Our experience is that the median weight loss is around 10% body weight but that weight is put on again after the six months of balloon placement. However, the procedure may allow the individual to know what weight loss feels like and this may motivate them towards their goal (Figure 44.1).

Duodenojejunal bypass liner

The duodenojejunal bypass liner (DJBL) (EndoBarrier gastrointestinal liner, GI Dynamics, Lexington, MA) is an endoscopically placed and removable intestinal liner. The DJBL causes mechanical nonabsorption of nutrients in the proximal part of the small intestine and resembles the most popular bariatric surgical method – Roux‐Y‐gastric bypass.

The device is composed of a self‐expanding nickel‐titanium anchor attached to a 61 cm long polymer sleeve (Figure 44.2). In the original form and during delivery, the anchor and sleeve are in a collapsed form packed in a protective white capsule (see Figure 44.2). Three days before the procedure, therapy with proton pump inhibitors (PPI) should be started. In addition, before the procedure antibiotic prophylaxis is indicated.

The endoscopic placement is usually performed in the theater with the patient under general anesthesia. Two pediatric gastroenterologists are required to perform the procedure. The first performs the endoscopy and the second assists with DJBL accessories to position and deploy the device (Figure 44.3). A guidewire is advanced deep into the duodenum with fluoroscopic guidance. The device enclosed in a capsule is advanced over the guidewire (Figure 44.4). The sleeve is then deployed in the proximal intestine (Figure 44.5). When the sleeve is fully extended with the help of the ball, contrast medium and air, and the anchor is located in the duodenal bulb distal to the pylorus, the self‐expandable anchor is deployed from the capsule. The position of the device is visualized through the tip of the endoscope kept in stomach during the entire procedure. The position of the crowns (anchor) is carefully inspected again at the end of the placement to correct the crossing or malposition of the crowns with the endoscope (Figure 44.6). Placement of the DJBL takes on average half an hour.

Usually painkillers and antiemetics are prescribed for the first few days to prevent vomiting and anchor migration. For the same reason, a liquid diet during the first two weeks after placement is advised. The device is usually left in place for 12 months. The patient should be kept on regular PPI treatment one year after the procedure to prevent duodenal ulcers and bleeding, and should be advised to avoid any contact sports to prevent possible device migration. Patients are also advised to drink a lot of liquids, chew food well and eat slowly, and avoid raw fruits and vegetables in their diet to prevent mechanical sleeve obstruction.

Device removal is performed under general anesthesia, using a retrieval device. A special foreign body hood is placed at the tip of the endoscope. The tip of the endoscope with the hood is positioned in the duodenal bulb. One of the drawstrings located at the crown of the device is pulled into the hood, thus collapsing the device crowns into the hood. After ensuring fluoroscopically that secure position of all the barbs inside the hood is achieved, the DJBL can be pulled out of the duodenum into the stomach lumen. After complete removal of the device, the endoscopy should be repeated to inspect the site where anchor was attached to the duodenal mucosa for possible bleeding. Usually pseudopolyps can be seen in the duodenal bulb (Figure 44.7). PPI therapy is discontinued two weeks after device removal. The liner can be reimplanted into the same patient after a period of a few months.

In adults, placement of the DJBL device was first described in 2008 by Rodriguez‐Grunert et al., and has been used successfully since as a treatment for morbid obesity with co‐morbidities. The American Society for Gastrointestinal Endoscopy recently published a metaanalysis of the DJBL in adults. Out of 135 citations, 11 full‐length manuscripts have met strict inclusion criteria. Three trials enrolling 105 patients treated for 12 months indicated that the DJBL achieved 35.3% of excess weight loss (%EWL) (95% confidence interval [CI] 24.6–46.1). In four randomized controlled trials that compared DJBL and control groups of patients after 12–24 weeks of treatment, the mean %EWL difference between the groups was 9.4% (95% CI 8.26–10.65). When the authors looked at the impact on obesity‐related co‐morbidities, such as glycosylated hemoglobin (HbA1c), they reported significant improvements of −0.7 (95% CI −1.76 to 0.2; p = 0.16), −1.7 (95% CI −2.5 to −0.86; p <0.001), and −1.5 (95% CI −2.2 to −0.78; p <0.001) after 12, 24, and 52 weeks of DJBL implantation, respectively.

In a safety analysis, 271 patients with DJBL placement were included. Reported serious adverse events were linear migration (4.9%), gastrointestinal bleeding (3.86%), sleeve obstruction (3.4%), liver abscess (0.13%), cholangitis (0.13%), acute cholecystitis (0.13%), and esophageal perforation (0.13%). Among other adverse events, pain was described in 58.7%, and nausea and vomiting in 39.4% of cases. Early removal of the device because of adverse events was reported in 18.4% of patients. In general, the safety profile of the DJBL was established as acceptable but there was one exception in a US multicenter trial in which a higher than anticipated rate of hepatic abscess was reported and enrolment of new patients was temporarily halted.

For the first time in children, our research group evaluated the efficacy and safety of DJBL and its effects on weight loss, metabolic and cardiovascular parameters. The device was successfully implanted in 14 morbidly obese adolescents out of 17 who underwent the procedure (10 females, mean age 17.7 years, range 15.0–19.2; average body weight 124.3 kg, range 93.2–158.8). Inclusion criteria were BMI ≥35 kg/m² with obesity complications such as hypertension, prediabetes or type 2 diabetes. The BMI (kg/m²) was measured at 0, 3, 6, 9, and 12 months and was shown to have decreased at all time frames (42.3 [range 36.7–48.8], 38.0 [range 34.1–44.5], 37.7 [range 33.3–44.8], 37.5 [range 33.1–45.5], and 36.7 [range 32.4–45.9], respectively). In addition, glucose metabolism significantly improved: mean HOMA‐IR level at the beginning of the study was 5.6 (± 2,2) and decreased at six and 12 months after implantation (3.8 ± 1.6 and 2.7 ± 0.9, respectively). The most frequent adverse events were of gastrointestinal origin and were reported mostly in the first two weeks after implantation: nausea in six out of 14 cases, abdominal pain in eight out of 14 children, and diarrhea in two out of 14 adolescents which is comparable with adult data. With the exception of one case of acute cholecystitis that presented three months after liner placement, there were no severe procedure‐ or postprocedure‐related complications similarly to those that are described in adults. Adolescents were followed up for 12 months. Significant weight loss was detected in most adolescent subjects, and glucose metabolism improved in all. The study is still ongoing.

Conclusion

Obesity is a global epidemic and is associated with multiple co‐morbidities. It has a great impact on health and quality of life that starts as early as childhood and is even greater later in life. Therefore, it is of great importance to successfully treat obesity early in life to prevent future complications. Diet, lifestyle modification, and medicinal drugs have only minimal efficacy on losing weight. Invasive options, primarily bariatric surgery, have been shown to be more effective, but are rarely utilized in children. EBTs may be a better option for children. Use of space‐occupying intragastric balloons offers reversible weight management that has proven to be more effective than diet and lifestyle changes. The new technique of DJBL, resembling the Roux‐Y‐gastric bypass, is even more effective and regarded as safer than bariatric surgical methods, but more data on use in the pediatric population are needed.

The new endoscopic therapy for obesity will evolve in future, but it is of major importance that only those children who meet strict indications are considered for the endoscopic procedure.