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Novel and emerging devices and operations in the treatment of obesity in children and adolescents
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Contents lists available at ScienceDirect
Seminars in Pediatric Surgery journal homepage: www.elsevier.com/locate/sempedsurg
Novel and emerging devices and operations in the treatment of obesity in children and adolescents Hae Sung Kang a, Jonathan DeAntonio a, Claudio Oiticica a, David Lanning a,∗, Allen Browne b a b
Department of Surgery, Children’s Hospital of Richmond at Virginia Commonwealth University, Richmond, VA, United States Dr. Allen F. Browne, LLC, Falmouth, ME, United States
a r t i c l e
i n f o
Article history: Available online xxx Keywords: Adolescent Bariatric Obesity Technology Novel Device Metabolic Surgery
a b s t r a c t Obesity is among the most common and costly chronic disorders worldwide. Estimates suggest that in the United States obesity affects one-third of adults, accounts for up to one-third of total mortality, is concentrated among lower income groups, and increasingly affects children as well as adults. A lack of effective options for long-term weight reduction magnifies the enormity of this problem; individuals who successfully complete behavioral and dietary weight-loss programs eventually regain most of the lost weight. We included evidence from basic science, clinical, and epidemiological literature to assess current knowledge regarding mechanisms underlying excess body-fat accumulation, the biological defense of excess fat mass, and the tendency for lost weight to be regained. A major area of emphasis is the science of energy homeostasis, the biological process that maintains weight stability by actively matching energy intake to energy expenditure over time. Growing evidence suggests that obesity is a disorder of the energy homeostasis system, rather than simply arising from the passive accumulation of excess weight. We need to elucidate the mechanisms underlying this “upward setting” or “resetting” of the defended level of body-fat mass, whether inherited or acquired. The ongoing study of how genetic, developmental, and environmental forces affect the energy homeostasis system will help us better understand these mechanisms and are therefore a major focus of this statement. The scientific goal is to elucidate obesity pathogenesis so as to better inform treatment, public policy, advocacy, and awareness of obesity in ways that ultimately diminish its public health and economic consequences. © 2020 Elsevier Inc. All rights reserved.
Introduction As the obesity epidemic continues to expand in the pediatric population, there has been a corresponding increase in support of metabolic and bariatric surgery (MBS) in adolescent patients. Multiple studies have shown that most cases of adolescent obesity do not resolve with lifestyle modification alone and that surgical treatment is effective and safe.1–4 However, there has been significant concern about risks of the currently available surgical options and this concern may well limit referral of adolescent patients with the disease of severe obesity for otherwise appropriate surgical care. In fact, a survey amongst pediatricians revealed that half of the pediatricians would not refer their patients to a pediatric surgeon regardless of the severity of their obesity.5 In addition, a survey of parents in 2012 revealed less than a third of the parents thought bariatric surgery was an option for children.6 In 2009, there were 1615 total inpatient admissions for MBS
∗
Correspondence author. E-mail address: [email protected] (D. Lanning).
procedures based on the Kids’ Inpatient Database, which would be less than 0.1% of adolescents who met the criteria.7 This percentage has been recently increasing as one study found a 1.8-fold increase in the number of adolescent MBS cases in children’s hospitals from 2012 to 2016.8 The recent policy statement from the American Academy of Pediatrics on MBS reflects this shift as it recommends pediatricians make timely referrals to comprehensive, multidisciplinary, pediatric-focused MBS programs for those who meet the criteria.9 To the extent that new devices and procedures are safe, effective and less invasive, more families and primary care providers may adopt a more aggressive approach to the workup and referral of those with pediatric severe obesity. The body has a complex energy regulatory system (ERS) that tries to maintain the body composition around a set point. Even if this is set at an unhealthy level, the ERS will defend this level with a homeostatic mechanism.10–12 In pediatric patients, this is possibly complicated by plasticity. Though not clearly elucidated yet, it is currently thought that there may be a “developmental window” for the maturation of energy homeostasis neurocircuitry.10 Because of the evolving body habitus of children and the plastic-
https://doi.org/10.1016/j.sempedsurg.2020.150881 1055-8586/© 2020 Elsevier Inc. All rights reserved.
Please cite this article as: H.S. Kang, J. DeAntonio and C. Oiticica et al., Novel and emerging devices and operations in the treatment of obesity in children and adolescents, Seminars in Pediatric Surgery, https://doi.org/10.1016/j.sempedsurg.2020.150881
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ity of the energy homeostasis system, MBS in the pediatric population should be tailored to each patient and the adjustability and reversibility of the intervention must be considered. In addition, the benefits of invasive surgical intervention must be carefully weighed against risks given the vulnerability of this population and general reluctance to consider surgical interventions. Therefore, though an intervention may not achieve normalization of weight status, it may still be considered in the pediatric population if it is well tolerated, adjustable, reversible, minimally invasive, and does not interfere with important developmental processes. These considerations may lead to wider acceptance by families, referring providers and payers. This article will focus on new weight-loss procedures and devices that seem attractive specifically in the pediatric population. They may not result in a weight loss as significant as the more conventional surgical procedures such as laparoscopic sleeve gastrectomy (LSG) or Roux-en-Y gastric bypass (RYGB), but they may take advantage of plasticity of ERS and allow more children with the disease of obesity to be healthier. New MBS procedures Laparoscopic gastric plication (LGP) is a surgical technique that involves reducing the gastric volume to approximately 50 ml by folding the stomach into itself starting at the angle of His and directed caudally along the greater curvature of the stomach. Typically, two rows of running 2–0 polyprolene are used in the plication. This procedure does not involve transection or removal of any tissue or insertion of a foreign body and can be completely reversed or converted to a RYGB or LSG. However, the gastric plication has demonstrated mixed results, with some studies finding it to be associated with more nausea and inferior weight loss when compared to the LSG.13–17 In a 12-year series of 791 adult and 9 pediatric patients, the LGP was associated with 42% excess weight loss (EWL) over 10 years after surgery and significant improvement of diabetes, hypertension and hyperlipidemia.18 A systematic review of 11 studies focusing on LGP found a major complication rate of 4%, including gastric obstruction (1.5%), suture line leak (0.7%) and upper gastrointestinal bleed (0.6%).19 In one study, 30 of 100 LGP cases were converted to 17 LSG and 13 RYGB because of poor weight loss at the 6-month mark. There were no complications reported with these revisions.20 A pilot study of LGP in twelve adolescents in Iran showed nearly 70% EWL and remission of all medical comorbidities including diabetes and hypertension. There was one significant complication of obstruction at one of the plication sites.21 Another pilot study of LGP in four adolescents in the US showed an average BMI loss of 12% at 90 days and 29% at 36 months without any complications. In addition, it had an added psychological benefit including increased physical comfort, self-esteem, social life and family relations.22 Endoscopic sleeve gastroplasty (known as ESG or accordion procedure) is an entirely incision-less procedure as it is done endoscopically. There are multiple endoscopic platforms for gastric plication such as Incisionless Operating Platform for Primary Obesity Surgery Endolumenal (POSE; USGI Medical, San Clemente, CA, USA) and RESTORe suturing system (Bard Davol, Warwick, RI, USA), but only Overstitch for Endoscopic Sleeve Gastroplasty (Apollo Endosurgery, Austin, TX, USA) is currently FDA-approved for tissue apposition purposes.23 By using a multi-channel endoscopic platform, the greater curvature of the stomach is imbricated with a triangular pattern of sutures. While having a similar mechanism as a gastric plication, it has the benefit of potentially avoiding some surgical complications while minimizing patient discomfort. A multi-center prospective study of 248 adult patients with ESG showed nearly 20% total body weight loss (TBWL) at 24 months and 2% rate of procedure-related complications, which included two cases of perigastric leak that were managed with a drain and
antibiotics.24 It also resulted in significant improvement in diabetes, hypertension and hypertriglyceridemia.25 One retrospective cohort study compared ESG to LSG and gastric band placement and demonstrated ESG to have significant higher weight loss (18% TBWL) than gastric band patients (13% TBWL) and a lower complication rate (2%) than both LSG (9%) and gastric band patients (9%). In addition, the LOS for ESG was less than half of a day, significantly less than LSG (3.1 days) or gastric band (1.7 days).26 A prospective study of ESG performed on 109 adolescents and young adults ranging from 10 to 21-years-olds (average 17.6 ± 2.2) in Saudi Arabia showed 14% TWBL after 24 months. All of the comorbidities including OSA, hypertension and prediabetes had resolved by 3 months while no adverse events were reported.27 There has not been a study regarding the reversibility of ESG but a case report of conversion of POSE procedure into LSG noted that there were dense adhesions caused by the endoscopic sutures, which made releasing the plication difficult.28 Laparoscopic mini gastric bypass (one anastomosis or omega gastric bypass [OAGB]) is another surgical alternative that has recently gained more attention in adults. It involves creating a long gastric reservoir of about 13 to 15 cm in length and bringing up a loop of jejunum 200 cm to 300 cm distal to the Ligament of Treitz to create a gastrojejunostomy, effectively making a gastric bypass with one small bowel limb. With only one anastomosis, expected benefits include shorter operative times, decreased technical difficulty and fewer complications such as anastomotic leak and internal hernia. However, there has been widespread skepticism about this procedure given its inherent potential complication of bile reflux, as it is similar to a Billroth II operation. A large, single center study with 1200 cases of OAGB in Spain showed 77% and 70% EWL at 6 and 12 years, respectively. Interestingly, this study enrolled patients as young as twelve (the average age in the study was 44) though it is not clear how many of the patients were under 18 and the results were not reported by age.29 A meta-analysis of 16 studies comparing the OAGB procedure to RYGB has shown the OAGB to have a significantly greater weight loss than RYGB at 1, 2 and 5 year follow-up. Notably, compared to RYGB, OAGB resulted in a greater remission of diabetes and similar remission of hypertension and dyslipidemia. In addition, OAGB resulted in a shorter mean procedural time of 46 minutes. Regarding technical complications, OAGB demonstrated a lower rate of small bowel obstruction due to internal hernia and similar rate of anastomotic leak as RYGB.30 However, OAGB also has a greater risk of adverse longterm effects. In one multi-center randomized controlled trial comparing RYGB to OAGB, EGD was performed at the two-year follow up and 16% of OAGB patients had bile in the stomach compared to none in the RYGB group. The OAGB patients had an increased incidence of gastritis and esophagitis and two patients had evidence of metaplasia in random esophageal biopsies.31 In addition, OAGB has been associated with severe nutritional deficiencies. In a retrospective study in France, 26 of 2,934 patients with OAGB underwent complete reversal of OAGB due to medically refractory protein malnutrition.32 In addition, there have been reported cases of Wernicke’s encephalopathy in OAGB patients, one requiring conversion to RYGB.30 , 31 , 33 This procedure has not been studied in the pediatric population though it is gaining acceptance in adults as it is now the third most commonly performed bariatric procedure in the world.34 Weight loss devices Currently, there are three intragastric balloons on the market that are FDA approved for use in adults with obesity: Orbera (Apollo Endosurgery, Austin, TX, USA), Reshape Duo Balloons (Reshape Lifesciences, San Clemente, CA, USA) and Obalon (Obalon Therapeutics, Carlsbad, CA, USA). These devices have similar re-
Please cite this article as: H.S. Kang, J. DeAntonio and C. Oiticica et al., Novel and emerging devices and operations in the treatment of obesity in children and adolescents, Seminars in Pediatric Surgery, https://doi.org/10.1016/j.sempedsurg.2020.150881
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sults in adult and limited pediatric studies. They are temporary, adjustable, safe, and involve one or more endoscopies. The Elipse system (Allurion, Natick, MA, USA) is a unique intragastric balloon that does not require any endoscopies and is currently in a clinical trial to be approved by the FDA. The patient swallows this balloon, which is attached to a catheter, and its placement within the stomach is confirmed with fluoroscopy. The balloon is then inflated with saline using the catheter, which is then detached after confirmation of satisfactory placement. The balloon is designed to degrade over 4 months and passes naturally from the gastrointestinal tract. Thus far, studies have shown 10–17% TBWL at 4-month follow up and 6% TBWL at 12 month follow up in adults.35–38 Follow up data beyond 12 months are not available. There have been three reported cases of premature balloon migration causing small bowel obstruction requiring operative exploration and additional endoscopic procedures.39 , 40 The Transpyloric Shuttle (TPS; BAROnova, San Carlos, CA, USA) is a device approved by the FDA for adults with obesity. It requires two endoscopies, one for the delivery of the device and another for removal. It has two components: a large bulb in the stomach and a small one in the duodenum, which are connected by a tether. The device is delivered endoscopically and then its large bulb is filled with a radiopaque internal coil, which locks it into a spherical shape. With these balloons in place, peristalsis results in an intermittent pyloric obstruction, ultimately leading to delayed gastric emptying. The device can remain in place up to 12 months and is then removed endoscopically. This device was approved by the FDA for clinical use in adults with a BMI of 35 to 40 kg/m2 and those with a BMI of 30 to 35 kg/m2 with associated comorbidities. In a randomized controlled trial with 270 adult patients (181 with TPS), the study group showed 10% TBWL, significantly higher than the control (3%) after 12 months of therapy. The impact of this device on cardiometabolic risk factors remains to be seen. Ulceration was reported in 10% of patients using this device. All ulcers except one were located in the stomach with the majority in the pre-pyloric location. All cases resolved with medical therapy. In addition, 2% of the patients developed gastric impaction, requiring endoscopic removal of the device. The rate of early device removal due to intolerance was 15% with persistent upper abdominal pain and vomiting the most common symptoms of intolerance.41 AspireAssist (Aspire Bariatrics, Exton, PA, USA) is a gastrostomy tube placed using an endoscope. It is designed for removal of calories from the stomach. A percutaneously placed endoscopic gastrostomy tube (A-tube) drains the stomach content using gravity about 20 to 30 min after a meal. The tube is then irrigated until the drainage is clear. Up to 30% of the caloric value of a meal can be removed using this device.42 AspireAssist is currently FDA approved for weight loss in adults with BMI of 35 to 55 kg/m2 after failure of medical therapy. A US multi-center randomized controlled trial that compared 111 adult patients with the device to 60 control patients showed 12% TBWL after 52 weeks of therapy, which was significantly higher than the control group at 4%.43 At the four year follow up, which did not include controls, the patients that remained enrolled in the study (58 of 111 patients) showed 19% TBWL.44 This long-term result was corroborated by a European study.45 The study group had significant improvement in HbA1C, cholesterol level, and blood pressure.44 , 45 Regarding possible complications, no tubes had to be removed due to clogging. The vast majority (90%) of the complications from this device were known complications from PEG tubes; there were seven cases of buried bumpers which required temporary placement of conventional PEG tube, which was later replaced with the A-tube. There was one case of peritonitis and another with prepyloric ulcer, which both required additional medical treatment.45 There were no signs of development of bulimia nervosa or binge-eating syndrome in these patients.43 There has been a high rate of persistent
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gastrocutaneous fistula (33%) after the A-tube was removed after 2 years of therapy, requiring additional interventions to repair the fistula.44 , 45 There is a report of successful conversion from this device to LSG.46 There have been multiple recently developed endoscopic bypass devices. One of such devices is duodenal-jejunal bypass sleeve liner (DJBL, EndoBarrier; GI Dynamics, Boston, MA, USA). As its name suggests, it is a 60 cm impermeable sleeve that is secured in the duodenal bulb and ends at the jejunum, thereby allowing food to travel further in the bowel before mixing with bile and pancreatic secretions. The device is delivered endoscopically and fixed to the duodenum using a nitinol anchor and is removed endoscopically. It appears to be associated with increasing incretin hormone levels such as GLP-1 and PYY while decreasing the level of GIP.47 It prevents food from direct contact with the duodenum and the first part of the jejunum, which may play a major role in its mechanism. This is consistent with its proposed mechanism of mimicking the bowel physiology of gastric bypass. It is not FDA approved as it had an unexpected association with hepatic abscess (4%) during a clinical trial in the U.S, resulting in an early termination of the trial.48 Currently, there is an ongoing effort to restart a clinical trial with a procedural adjustment to decrease the likelihood of this complication. In a randomized controlled trial with 77 adults who underwent DJBL therapy for 6 months, 32% EWL was reported at 6 months and 20% EWL at 12 months, both significantly greater weight loss compared to the control group.49 A meta-analysis of diabetic obese patients treated with this device concluded that it resulted in improved glycemic control up to 6 months after removal of the device.47 A review of safety of this sleeve at a European medical center that had performed 152 DJBL implantation demonstrated 16 cases of early explantation due to device intolerance such as abdominal pain and nausea, 7 cases of GI bleed, 2 cases of pancreatitis, 1 case of hepatic abscess and 1 obstruction of the sleeve. Of the 94 explantations performed, there were two cases of esophageal tear during the procedure.50 Another noteworthy sleeve device is called the gastroduodenal-jejunal bypass sleeve (GJBS, ValenTx; ValenTx, Maple Grove, MN, USA) and it closely mimics the physiology of gastric bypass. It requires fluoroscopy-guided delivery of the 120 cm sleeve to the proximal jejunum, endoscopic suture placements to anchor the sleeve to the GE junction and laparoscopic confirmation of safe suture placements and approximation of the diaphragmatic esophageal crura. After a year, the device deteriorates and has to be removed endoscopically. There has been one study published regarding this device: a single-center prospective study with twelve adult patients. Two devices had to be explanted within one month due to patient intolerance (dysphagia and odynophagia.) Ten patients tolerated the implant for the study period of 12 months. The mean %EWL of the ten patients was 36%. However, four patients experienced partial cuff detachment at the GE junction at the conclusion of the study and had lower %EWL than those with intact cuff, lowering the average %EWL. The mean %EWL of the patients with intact cuff after one year of therapy was 54%. A 14 month follow up after the explant of the device showed an average 30% EWL. In addition, there was an improvement in HbA1C, blood pressure and cholesterol levels. There were no complications during implantation and explantation procedures and followup endoscopy did not show any adhesions, in-growth or inflammation due to the sleeve. There were no significant adverse events associated with the procedure.51 Vagus nerve stimulator (VBLOC; Reshape Lifesciences, San Clemente, CA, USA) is a reversible, adjustable FDA approved device for severely obese adults. Its electrodes are laparoscopically placed on the anterior and posterior vagus nerves at the GE junction and attached to a neuroregulator implanted subcutaneously. The vagus nerves have been noted to be involved in the ERS via afferent mes-
Please cite this article as: H.S. Kang, J. DeAntonio and C. Oiticica et al., Novel and emerging devices and operations in the treatment of obesity in children and adolescents, Seminars in Pediatric Surgery, https://doi.org/10.1016/j.sempedsurg.2020.150881
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sages to the hypothalamus from the GI tract. A double blind randomized controlled trial in adult patients has shown 24% EWL in the device group versus 16% in the control group after one year of therapy and 21% and 4% after two years, respectively.52 , 53 At two years, the study group also showed significant improvement in blood pressure, cholesterol and glycemic control compared to the baseline.51 The main adverse event associated with this device is dyspepsia, which occurred in 23% of the patients with the device though the symptoms were noted to be mild in most cases.52 Conclusion There are a number of new bariatric procedures and devices that show promise in their applicability to pediatric patients with obesity. Currently, only a small fraction of pediatric patients that meet indications receive MBS or any of the advanced tools of weight management. There are many barriers for pediatric patients to receive appropriate care for weight management. There is a lack of education in the general public regarding the ERS and the physiology of the disease of obesity, resulting in a persistent bias that obesity develops because of the child and his or her parents’ voluntary, conscious behaviors. This results in general skepticism of the role of MBS and other advanced tools of weight management for pediatric patients with obesity. The invasive nature of surgery and the lack of payer support only add to this reservation. However, given the principle of plasticity and the complications of the disease of obesity, it is critical that obesity is addressed at an age in which the homeostatic calorie set point could possibly be altered by therapy. These alternative interventions may be legitimate options to the traditional surgical therapies, alleviating some of the concerns while still decreasing the disease burden. While they may be inferior to other surgical procedures for weight loss and improvement in comorbidities, their versatility as adjustable/reversible procedures and the ability to combine them with other advanced therapies may allow more children with obesity to receive treatment. In addition, they may serve as a bridge to a conventional surgical therapy as an adult. The course of therapy should be tailored to patients based on their risk and benefit profile to offer the best sustainable treatment option. Unfortunately, with the exception of LGP and ESG, there have not been any dedicated pediatric studies of the procedures and devices presented in this article. Their effectiveness may be modified by the plasticity of the disease in the pediatric age group. As a result, rigorous studies at multi-disciplinary pediatric weight management programs should be conducted to ascertain the applicability of these devices. As medical devices and bariatric procedures continue to be refined, these resources may be viable alternatives for pediatric patients and their families with the goal of addressing the disease in a critical period of its development. Declaration of Competing Interest None declared. References 1. Luttikhuis HO, Baur L, Jansen H, et al. Interventions for treating obesity in children. Cochrane Datab Syst Rev. 2009. doi:10.10 02/14651858.cd0 01872.pub2. 2. Durkin N, Desai AP. What is the evidence for paediatric/adolescent bariatric surgery? Curr Obes Rep. 2017;6(3):278–285. doi:10.1007/s13679- 017- 0277- 4. 3. Childerhose JE, Alsamawi A, Mehta T, Smith JE, Woolford S, Tarini BA. Adolescent bariatric surgery: a systematic review of recommendation documents. Surg Obes Relat Dis. 2017;13(10):1768–1779. doi:10.1016/j.soard.2017.08.008. 4. Janicke DM, Steele RG, Gayes LA, et al. Systematic review and meta-analysis of comprehensive behavioral family lifestyle interventions addressing pediatric obesity. J Pediatr Psychol. 2014;39(8):809–825. doi:10.1093/jpepsy/jsu023. 5. Woolford SJ, Clark SJ, Gebremariam A, Davis MM, Freed GL. To cut or not to cut: physicians’ perspectives on referring adolescents for bariatric surgery. Obes Surg. 2010;20(7):937–942. doi:10.1007/s11695- 010- 0152- 9.
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Please cite this article as: H.S. Kang, J. DeAntonio and C. Oiticica et al., Novel and emerging devices and operations in the treatment of obesity in children and adolescents, Seminars in Pediatric Surgery, https://doi.org/10.1016/j.sempedsurg.2020.150881
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H.S. Kang, J. DeAntonio and C. Oiticica et al. / Seminars in Pediatric Surgery xxx (xxxx) xxx 33. Bétry C, Disse E, Chambrier C, et al. Need for intensive nutrition care after bariatric surgery. J Parenterl Enter Nutr. 2016;41(2):258–262. doi:10.1177/ 0148607116637935. 34. Welbourn R, Pournaras DJ, Dixon J, et al. Bariatric surgery worldwide: baseline demographic description and one-year outcomes from the second IFSO global registry report 2013–2015. Obes Surg. 2017;28(2):313–322. doi:10.1007/ s11695- 017- 2845- 9. 35. Machytka E, Gaur S, Chuttani R, et al. Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study. Endoscopy. 2016;49(02):154–160. doi:10.1055/s- 0042- 119296. 36. Raftopoulos I, Giannakou A. The Elipse Balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12-month outcomes. Surg Obes Relat Dis. 2017;13(7):1174–1182. doi:10.1016/j.soard.2017.02.016. 37. Alsabah S, Haddad EA, Ekrouf S, et al. The safety and efficacy of the procedureless intragastric balloon. Surg Obes Relat Dis. 2018;14(3):311–317. doi:10.1016/j. soard.2017.12.001. 38. Genco A, Ernesti I, Ienca R, et al. Safety and efficacy of a new swallowable intragastric balloon not needing endoscopy: early Italian experience. Obes Surg. 2017;28(2):405–409. doi:10.1007/s11695- 017- 2877- 1. 39. Al-Subaie S, Al-Barjas H, Al-Sabah S, Al-Helal S, Alfakharani A, Termos S. Laparoscopic management of a small bowel obstruction secondary to Elipse intragastric balloon migration: a case report. Int J Surg Case Rep. 2017;41:287–291. doi:10.1016/j.ijscr.2017.10.050. 40. Angrisani L, Santonicola A, Vitiello A, Belfiore MP, Belfiore G, Iovino P. Elipse balloon: the pitfalls of excessive simplicity. Obes Surg. 2018;28(5):1419–1421. doi:10.1007/s11695- 018- 3148- 5. 41. Food and Drug Administration of U. S. (2019, April). Summary of Safety and Effectiveness Data – TransPyloric Shuttle/Transpyloric Shuttle Delivery Device. Retrieved from https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180024B.pdf 42. Sullivan S, Stein R, Jonnalagadda S, Mullady D, Edmundowicz S. Aspiration therapy leads to weight loss in obese subjects: a pilot study. Gastroenterology. 2013;145(6). doi:10.1053/j.gastro.2013.08.056. 43. Thompson CC, Dayyeh BKA, Kushner R, et al. Percutaneous gastrostomy device for the treatment of class ii and class iii obesity: results of a randomized controlled trial. Am J Gastroenterol. 2017;112(3):447–457. doi:10.1038/ajg.2016.500.
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44. Thompson CC, Dayyeh BKA, Kushnir V, et al. Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial. Surg Obes Relat Dis. 2019;15(8):1348–1354. doi:10.1016/j.soard.2019.04.026. 45. Nyström M, Machytka E, Norén E, et al. Aspiration therapy as a tool to treat obesity: 1- to 4-year results in a 201-patient multi-center postmarket european registry study. Obes Surg. 2018;28(7):1860–1868. doi:10.1007/ s11695- 017- 3096- 5. 46. Vilallonga R, Bademci R, Roriz-Silva R, Sanchez-Cordero S, Curbelo Y, Almanza A. Conversion of aspireassist system® to sleeve gastrectomy: technical video description. Obes Surg. 2019;29(8):2715–2717. doi:10.1007/s11695- 019- 03993- 3. 47. Jirapinyo P, Haas AV, Thompson CC. Effect of the duodenal-jejunal bypass liner on glycemic control in patients with type 2 diabetes with obesity: a metaanalysis with secondary analysis on weight loss and hormonal changes. Diabetes Care. 2018;41(5):1106–1115. doi:10.2337/dc17-1985. 48. National Institute of Health of U. S. (2017, February). Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese. Retrieved from https://clinicaltrials.gov/ct2/show/NCT01728116 49. Koehestanie P, Jonge CD, Berends FJ, et al. The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial. Ann Surg. 2014;260(6):984–992. doi:10. 1097/sla.0 0 0 0 0 0 0 0 0 0 0 0 0794. 50. Betzel B, Koehestanie P, Aarts EO, et al. Safety experience with the duodenaljejunal bypass liner: an endoscopic treatment for diabetes and obesity. Gastrointest Endosc. 2015;82(5):845–852. doi:10.1016/j.gie.2015.03.1911. 51. Sandler BJ, Rumbaut R, Swain CP, et al. One-year human experience with a novel endoluminal, endoscopic gastric bypass sleeve for morbid obesity. Surg Endosc. 2015;29(11):3298–3303. doi:10.10 07/s0 0464- 015- 4081- 5. 52. Ikramuddin S, Blackstone RP, Brancatisano A, et al. Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity. JAMA. 2014;312(9):915. doi:10.1001/jama.2014.10540. 53. Apovian CM, Shah SN, Wolfe BM, et al. Two-year outcomes of vagal nerve blocking (vBloc) for the treatment of obesity in the ReCharge trial. Obes Surg. 2016;27(1):169–176. doi:10.1007/s11695-016- 2325- 7.
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Contents lists available at ScienceDirect
Seminars in Pediatric Surgery journal homepage: www.elsevier.com/locate/sempedsurg
Novel and emerging devices and operations in the treatment of obesity in children and adolescents Hae Sung Kang a, Jonathan DeAntonio a, Claudio Oiticica a, David Lanning a,∗, Allen Browne b a b
Department of Surgery, Children’s Hospital of Richmond at Virginia Commonwealth University, Richmond, VA, United States Dr. Allen F. Browne, LLC, Falmouth, ME, United States
a r t i c l e
i n f o
Article history: Available online xxx Keywords: Adolescent Bariatric Obesity Technology Novel Device Metabolic Surgery
a b s t r a c t Obesity is among the most common and costly chronic disorders worldwide. Estimates suggest that in the United States obesity affects one-third of adults, accounts for up to one-third of total mortality, is concentrated among lower income groups, and increasingly affects children as well as adults. A lack of effective options for long-term weight reduction magnifies the enormity of this problem; individuals who successfully complete behavioral and dietary weight-loss programs eventually regain most of the lost weight. We included evidence from basic science, clinical, and epidemiological literature to assess current knowledge regarding mechanisms underlying excess body-fat accumulation, the biological defense of excess fat mass, and the tendency for lost weight to be regained. A major area of emphasis is the science of energy homeostasis, the biological process that maintains weight stability by actively matching energy intake to energy expenditure over time. Growing evidence suggests that obesity is a disorder of the energy homeostasis system, rather than simply arising from the passive accumulation of excess weight. We need to elucidate the mechanisms underlying this “upward setting” or “resetting” of the defended level of body-fat mass, whether inherited or acquired. The ongoing study of how genetic, developmental, and environmental forces affect the energy homeostasis system will help us better understand these mechanisms and are therefore a major focus of this statement. The scientific goal is to elucidate obesity pathogenesis so as to better inform treatment, public policy, advocacy, and awareness of obesity in ways that ultimately diminish its public health and economic consequences. © 2020 Elsevier Inc. All rights reserved.
Introduction As the obesity epidemic continues to expand in the pediatric population, there has been a corresponding increase in support of metabolic and bariatric surgery (MBS) in adolescent patients. Multiple studies have shown that most cases of adolescent obesity do not resolve with lifestyle modification alone and that surgical treatment is effective and safe.1–4 However, there has been significant concern about risks of the currently available surgical options and this concern may well limit referral of adolescent patients with the disease of severe obesity for otherwise appropriate surgical care. In fact, a survey amongst pediatricians revealed that half of the pediatricians would not refer their patients to a pediatric surgeon regardless of the severity of their obesity.5 In addition, a survey of parents in 2012 revealed less than a third of the parents thought bariatric surgery was an option for children.6 In 2009, there were 1615 total inpatient admissions for MBS
∗
Correspondence author. E-mail address: [email protected] (D. Lanning).
procedures based on the Kids’ Inpatient Database, which would be less than 0.1% of adolescents who met the criteria.7 This percentage has been recently increasing as one study found a 1.8-fold increase in the number of adolescent MBS cases in children’s hospitals from 2012 to 2016.8 The recent policy statement from the American Academy of Pediatrics on MBS reflects this shift as it recommends pediatricians make timely referrals to comprehensive, multidisciplinary, pediatric-focused MBS programs for those who meet the criteria.9 To the extent that new devices and procedures are safe, effective and less invasive, more families and primary care providers may adopt a more aggressive approach to the workup and referral of those with pediatric severe obesity. The body has a complex energy regulatory system (ERS) that tries to maintain the body composition around a set point. Even if this is set at an unhealthy level, the ERS will defend this level with a homeostatic mechanism.10–12 In pediatric patients, this is possibly complicated by plasticity. Though not clearly elucidated yet, it is currently thought that there may be a “developmental window” for the maturation of energy homeostasis neurocircuitry.10 Because of the evolving body habitus of children and the plastic-
https://doi.org/10.1016/j.sempedsurg.2020.150881 1055-8586/© 2020 Elsevier Inc. All rights reserved.
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ity of the energy homeostasis system, MBS in the pediatric population should be tailored to each patient and the adjustability and reversibility of the intervention must be considered. In addition, the benefits of invasive surgical intervention must be carefully weighed against risks given the vulnerability of this population and general reluctance to consider surgical interventions. Therefore, though an intervention may not achieve normalization of weight status, it may still be considered in the pediatric population if it is well tolerated, adjustable, reversible, minimally invasive, and does not interfere with important developmental processes. These considerations may lead to wider acceptance by families, referring providers and payers. This article will focus on new weight-loss procedures and devices that seem attractive specifically in the pediatric population. They may not result in a weight loss as significant as the more conventional surgical procedures such as laparoscopic sleeve gastrectomy (LSG) or Roux-en-Y gastric bypass (RYGB), but they may take advantage of plasticity of ERS and allow more children with the disease of obesity to be healthier. New MBS procedures Laparoscopic gastric plication (LGP) is a surgical technique that involves reducing the gastric volume to approximately 50 ml by folding the stomach into itself starting at the angle of His and directed caudally along the greater curvature of the stomach. Typically, two rows of running 2–0 polyprolene are used in the plication. This procedure does not involve transection or removal of any tissue or insertion of a foreign body and can be completely reversed or converted to a RYGB or LSG. However, the gastric plication has demonstrated mixed results, with some studies finding it to be associated with more nausea and inferior weight loss when compared to the LSG.13–17 In a 12-year series of 791 adult and 9 pediatric patients, the LGP was associated with 42% excess weight loss (EWL) over 10 years after surgery and significant improvement of diabetes, hypertension and hyperlipidemia.18 A systematic review of 11 studies focusing on LGP found a major complication rate of 4%, including gastric obstruction (1.5%), suture line leak (0.7%) and upper gastrointestinal bleed (0.6%).19 In one study, 30 of 100 LGP cases were converted to 17 LSG and 13 RYGB because of poor weight loss at the 6-month mark. There were no complications reported with these revisions.20 A pilot study of LGP in twelve adolescents in Iran showed nearly 70% EWL and remission of all medical comorbidities including diabetes and hypertension. There was one significant complication of obstruction at one of the plication sites.21 Another pilot study of LGP in four adolescents in the US showed an average BMI loss of 12% at 90 days and 29% at 36 months without any complications. In addition, it had an added psychological benefit including increased physical comfort, self-esteem, social life and family relations.22 Endoscopic sleeve gastroplasty (known as ESG or accordion procedure) is an entirely incision-less procedure as it is done endoscopically. There are multiple endoscopic platforms for gastric plication such as Incisionless Operating Platform for Primary Obesity Surgery Endolumenal (POSE; USGI Medical, San Clemente, CA, USA) and RESTORe suturing system (Bard Davol, Warwick, RI, USA), but only Overstitch for Endoscopic Sleeve Gastroplasty (Apollo Endosurgery, Austin, TX, USA) is currently FDA-approved for tissue apposition purposes.23 By using a multi-channel endoscopic platform, the greater curvature of the stomach is imbricated with a triangular pattern of sutures. While having a similar mechanism as a gastric plication, it has the benefit of potentially avoiding some surgical complications while minimizing patient discomfort. A multi-center prospective study of 248 adult patients with ESG showed nearly 20% total body weight loss (TBWL) at 24 months and 2% rate of procedure-related complications, which included two cases of perigastric leak that were managed with a drain and
antibiotics.24 It also resulted in significant improvement in diabetes, hypertension and hypertriglyceridemia.25 One retrospective cohort study compared ESG to LSG and gastric band placement and demonstrated ESG to have significant higher weight loss (18% TBWL) than gastric band patients (13% TBWL) and a lower complication rate (2%) than both LSG (9%) and gastric band patients (9%). In addition, the LOS for ESG was less than half of a day, significantly less than LSG (3.1 days) or gastric band (1.7 days).26 A prospective study of ESG performed on 109 adolescents and young adults ranging from 10 to 21-years-olds (average 17.6 ± 2.2) in Saudi Arabia showed 14% TWBL after 24 months. All of the comorbidities including OSA, hypertension and prediabetes had resolved by 3 months while no adverse events were reported.27 There has not been a study regarding the reversibility of ESG but a case report of conversion of POSE procedure into LSG noted that there were dense adhesions caused by the endoscopic sutures, which made releasing the plication difficult.28 Laparoscopic mini gastric bypass (one anastomosis or omega gastric bypass [OAGB]) is another surgical alternative that has recently gained more attention in adults. It involves creating a long gastric reservoir of about 13 to 15 cm in length and bringing up a loop of jejunum 200 cm to 300 cm distal to the Ligament of Treitz to create a gastrojejunostomy, effectively making a gastric bypass with one small bowel limb. With only one anastomosis, expected benefits include shorter operative times, decreased technical difficulty and fewer complications such as anastomotic leak and internal hernia. However, there has been widespread skepticism about this procedure given its inherent potential complication of bile reflux, as it is similar to a Billroth II operation. A large, single center study with 1200 cases of OAGB in Spain showed 77% and 70% EWL at 6 and 12 years, respectively. Interestingly, this study enrolled patients as young as twelve (the average age in the study was 44) though it is not clear how many of the patients were under 18 and the results were not reported by age.29 A meta-analysis of 16 studies comparing the OAGB procedure to RYGB has shown the OAGB to have a significantly greater weight loss than RYGB at 1, 2 and 5 year follow-up. Notably, compared to RYGB, OAGB resulted in a greater remission of diabetes and similar remission of hypertension and dyslipidemia. In addition, OAGB resulted in a shorter mean procedural time of 46 minutes. Regarding technical complications, OAGB demonstrated a lower rate of small bowel obstruction due to internal hernia and similar rate of anastomotic leak as RYGB.30 However, OAGB also has a greater risk of adverse longterm effects. In one multi-center randomized controlled trial comparing RYGB to OAGB, EGD was performed at the two-year follow up and 16% of OAGB patients had bile in the stomach compared to none in the RYGB group. The OAGB patients had an increased incidence of gastritis and esophagitis and two patients had evidence of metaplasia in random esophageal biopsies.31 In addition, OAGB has been associated with severe nutritional deficiencies. In a retrospective study in France, 26 of 2,934 patients with OAGB underwent complete reversal of OAGB due to medically refractory protein malnutrition.32 In addition, there have been reported cases of Wernicke’s encephalopathy in OAGB patients, one requiring conversion to RYGB.30 , 31 , 33 This procedure has not been studied in the pediatric population though it is gaining acceptance in adults as it is now the third most commonly performed bariatric procedure in the world.34 Weight loss devices Currently, there are three intragastric balloons on the market that are FDA approved for use in adults with obesity: Orbera (Apollo Endosurgery, Austin, TX, USA), Reshape Duo Balloons (Reshape Lifesciences, San Clemente, CA, USA) and Obalon (Obalon Therapeutics, Carlsbad, CA, USA). These devices have similar re-
Please cite this article as: H.S. Kang, J. DeAntonio and C. Oiticica et al., Novel and emerging devices and operations in the treatment of obesity in children and adolescents, Seminars in Pediatric Surgery, https://doi.org/10.1016/j.sempedsurg.2020.150881
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sults in adult and limited pediatric studies. They are temporary, adjustable, safe, and involve one or more endoscopies. The Elipse system (Allurion, Natick, MA, USA) is a unique intragastric balloon that does not require any endoscopies and is currently in a clinical trial to be approved by the FDA. The patient swallows this balloon, which is attached to a catheter, and its placement within the stomach is confirmed with fluoroscopy. The balloon is then inflated with saline using the catheter, which is then detached after confirmation of satisfactory placement. The balloon is designed to degrade over 4 months and passes naturally from the gastrointestinal tract. Thus far, studies have shown 10–17% TBWL at 4-month follow up and 6% TBWL at 12 month follow up in adults.35–38 Follow up data beyond 12 months are not available. There have been three reported cases of premature balloon migration causing small bowel obstruction requiring operative exploration and additional endoscopic procedures.39 , 40 The Transpyloric Shuttle (TPS; BAROnova, San Carlos, CA, USA) is a device approved by the FDA for adults with obesity. It requires two endoscopies, one for the delivery of the device and another for removal. It has two components: a large bulb in the stomach and a small one in the duodenum, which are connected by a tether. The device is delivered endoscopically and then its large bulb is filled with a radiopaque internal coil, which locks it into a spherical shape. With these balloons in place, peristalsis results in an intermittent pyloric obstruction, ultimately leading to delayed gastric emptying. The device can remain in place up to 12 months and is then removed endoscopically. This device was approved by the FDA for clinical use in adults with a BMI of 35 to 40 kg/m2 and those with a BMI of 30 to 35 kg/m2 with associated comorbidities. In a randomized controlled trial with 270 adult patients (181 with TPS), the study group showed 10% TBWL, significantly higher than the control (3%) after 12 months of therapy. The impact of this device on cardiometabolic risk factors remains to be seen. Ulceration was reported in 10% of patients using this device. All ulcers except one were located in the stomach with the majority in the pre-pyloric location. All cases resolved with medical therapy. In addition, 2% of the patients developed gastric impaction, requiring endoscopic removal of the device. The rate of early device removal due to intolerance was 15% with persistent upper abdominal pain and vomiting the most common symptoms of intolerance.41 AspireAssist (Aspire Bariatrics, Exton, PA, USA) is a gastrostomy tube placed using an endoscope. It is designed for removal of calories from the stomach. A percutaneously placed endoscopic gastrostomy tube (A-tube) drains the stomach content using gravity about 20 to 30 min after a meal. The tube is then irrigated until the drainage is clear. Up to 30% of the caloric value of a meal can be removed using this device.42 AspireAssist is currently FDA approved for weight loss in adults with BMI of 35 to 55 kg/m2 after failure of medical therapy. A US multi-center randomized controlled trial that compared 111 adult patients with the device to 60 control patients showed 12% TBWL after 52 weeks of therapy, which was significantly higher than the control group at 4%.43 At the four year follow up, which did not include controls, the patients that remained enrolled in the study (58 of 111 patients) showed 19% TBWL.44 This long-term result was corroborated by a European study.45 The study group had significant improvement in HbA1C, cholesterol level, and blood pressure.44 , 45 Regarding possible complications, no tubes had to be removed due to clogging. The vast majority (90%) of the complications from this device were known complications from PEG tubes; there were seven cases of buried bumpers which required temporary placement of conventional PEG tube, which was later replaced with the A-tube. There was one case of peritonitis and another with prepyloric ulcer, which both required additional medical treatment.45 There were no signs of development of bulimia nervosa or binge-eating syndrome in these patients.43 There has been a high rate of persistent
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gastrocutaneous fistula (33%) after the A-tube was removed after 2 years of therapy, requiring additional interventions to repair the fistula.44 , 45 There is a report of successful conversion from this device to LSG.46 There have been multiple recently developed endoscopic bypass devices. One of such devices is duodenal-jejunal bypass sleeve liner (DJBL, EndoBarrier; GI Dynamics, Boston, MA, USA). As its name suggests, it is a 60 cm impermeable sleeve that is secured in the duodenal bulb and ends at the jejunum, thereby allowing food to travel further in the bowel before mixing with bile and pancreatic secretions. The device is delivered endoscopically and fixed to the duodenum using a nitinol anchor and is removed endoscopically. It appears to be associated with increasing incretin hormone levels such as GLP-1 and PYY while decreasing the level of GIP.47 It prevents food from direct contact with the duodenum and the first part of the jejunum, which may play a major role in its mechanism. This is consistent with its proposed mechanism of mimicking the bowel physiology of gastric bypass. It is not FDA approved as it had an unexpected association with hepatic abscess (4%) during a clinical trial in the U.S, resulting in an early termination of the trial.48 Currently, there is an ongoing effort to restart a clinical trial with a procedural adjustment to decrease the likelihood of this complication. In a randomized controlled trial with 77 adults who underwent DJBL therapy for 6 months, 32% EWL was reported at 6 months and 20% EWL at 12 months, both significantly greater weight loss compared to the control group.49 A meta-analysis of diabetic obese patients treated with this device concluded that it resulted in improved glycemic control up to 6 months after removal of the device.47 A review of safety of this sleeve at a European medical center that had performed 152 DJBL implantation demonstrated 16 cases of early explantation due to device intolerance such as abdominal pain and nausea, 7 cases of GI bleed, 2 cases of pancreatitis, 1 case of hepatic abscess and 1 obstruction of the sleeve. Of the 94 explantations performed, there were two cases of esophageal tear during the procedure.50 Another noteworthy sleeve device is called the gastroduodenal-jejunal bypass sleeve (GJBS, ValenTx; ValenTx, Maple Grove, MN, USA) and it closely mimics the physiology of gastric bypass. It requires fluoroscopy-guided delivery of the 120 cm sleeve to the proximal jejunum, endoscopic suture placements to anchor the sleeve to the GE junction and laparoscopic confirmation of safe suture placements and approximation of the diaphragmatic esophageal crura. After a year, the device deteriorates and has to be removed endoscopically. There has been one study published regarding this device: a single-center prospective study with twelve adult patients. Two devices had to be explanted within one month due to patient intolerance (dysphagia and odynophagia.) Ten patients tolerated the implant for the study period of 12 months. The mean %EWL of the ten patients was 36%. However, four patients experienced partial cuff detachment at the GE junction at the conclusion of the study and had lower %EWL than those with intact cuff, lowering the average %EWL. The mean %EWL of the patients with intact cuff after one year of therapy was 54%. A 14 month follow up after the explant of the device showed an average 30% EWL. In addition, there was an improvement in HbA1C, blood pressure and cholesterol levels. There were no complications during implantation and explantation procedures and followup endoscopy did not show any adhesions, in-growth or inflammation due to the sleeve. There were no significant adverse events associated with the procedure.51 Vagus nerve stimulator (VBLOC; Reshape Lifesciences, San Clemente, CA, USA) is a reversible, adjustable FDA approved device for severely obese adults. Its electrodes are laparoscopically placed on the anterior and posterior vagus nerves at the GE junction and attached to a neuroregulator implanted subcutaneously. The vagus nerves have been noted to be involved in the ERS via afferent mes-
Please cite this article as: H.S. Kang, J. DeAntonio and C. Oiticica et al., Novel and emerging devices and operations in the treatment of obesity in children and adolescents, Seminars in Pediatric Surgery, https://doi.org/10.1016/j.sempedsurg.2020.150881
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sages to the hypothalamus from the GI tract. A double blind randomized controlled trial in adult patients has shown 24% EWL in the device group versus 16% in the control group after one year of therapy and 21% and 4% after two years, respectively.52 , 53 At two years, the study group also showed significant improvement in blood pressure, cholesterol and glycemic control compared to the baseline.51 The main adverse event associated with this device is dyspepsia, which occurred in 23% of the patients with the device though the symptoms were noted to be mild in most cases.52 Conclusion There are a number of new bariatric procedures and devices that show promise in their applicability to pediatric patients with obesity. Currently, only a small fraction of pediatric patients that meet indications receive MBS or any of the advanced tools of weight management. There are many barriers for pediatric patients to receive appropriate care for weight management. There is a lack of education in the general public regarding the ERS and the physiology of the disease of obesity, resulting in a persistent bias that obesity develops because of the child and his or her parents’ voluntary, conscious behaviors. This results in general skepticism of the role of MBS and other advanced tools of weight management for pediatric patients with obesity. The invasive nature of surgery and the lack of payer support only add to this reservation. However, given the principle of plasticity and the complications of the disease of obesity, it is critical that obesity is addressed at an age in which the homeostatic calorie set point could possibly be altered by therapy. These alternative interventions may be legitimate options to the traditional surgical therapies, alleviating some of the concerns while still decreasing the disease burden. While they may be inferior to other surgical procedures for weight loss and improvement in comorbidities, their versatility as adjustable/reversible procedures and the ability to combine them with other advanced therapies may allow more children with obesity to receive treatment. In addition, they may serve as a bridge to a conventional surgical therapy as an adult. The course of therapy should be tailored to patients based on their risk and benefit profile to offer the best sustainable treatment option. Unfortunately, with the exception of LGP and ESG, there have not been any dedicated pediatric studies of the procedures and devices presented in this article. Their effectiveness may be modified by the plasticity of the disease in the pediatric age group. As a result, rigorous studies at multi-disciplinary pediatric weight management programs should be conducted to ascertain the applicability of these devices. As medical devices and bariatric procedures continue to be refined, these resources may be viable alternatives for pediatric patients and their families with the goal of addressing the disease in a critical period of its development. Declaration of Competing Interest None declared. References 1. Luttikhuis HO, Baur L, Jansen H, et al. Interventions for treating obesity in children. Cochrane Datab Syst Rev. 2009. doi:10.10 02/14651858.cd0 01872.pub2. 2. Durkin N, Desai AP. What is the evidence for paediatric/adolescent bariatric surgery? Curr Obes Rep. 2017;6(3):278–285. doi:10.1007/s13679- 017- 0277- 4. 3. Childerhose JE, Alsamawi A, Mehta T, Smith JE, Woolford S, Tarini BA. Adolescent bariatric surgery: a systematic review of recommendation documents. Surg Obes Relat Dis. 2017;13(10):1768–1779. doi:10.1016/j.soard.2017.08.008. 4. Janicke DM, Steele RG, Gayes LA, et al. Systematic review and meta-analysis of comprehensive behavioral family lifestyle interventions addressing pediatric obesity. J Pediatr Psychol. 2014;39(8):809–825. doi:10.1093/jpepsy/jsu023. 5. Woolford SJ, Clark SJ, Gebremariam A, Davis MM, Freed GL. To cut or not to cut: physicians’ perspectives on referring adolescents for bariatric surgery. Obes Surg. 2010;20(7):937–942. doi:10.1007/s11695- 010- 0152- 9.
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Please cite this article as: H.S. Kang, J. DeAntonio and C. Oiticica et al., Novel and emerging devices and operations in the treatment of obesity in children and adolescents, Seminars in Pediatric Surgery, https://doi.org/10.1016/j.sempedsurg.2020.150881