American Society for Gastrointestinal Endoscopy–European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity

Pichamol Jirapinyo; Alia Hadefi; Christopher C. Thompson; Árpád V. Patai; Rahul Pannala; Stefan K. Goelder; Vladimir Kushnir; Marc Barthet; Caroline M. Apovian; Ivo Boskoski; Christopher G. Chapman; Paul Davidson; Gianfranco Donatelli; Vivek Kumbhari; Bu Hayee; Janelle Esker; Tomas Hucl; Aurora D. Pryor; Roberta Maselli; Allison R. Schulman; Francois Pattou; Shira Zelber-Sagi; Paul A. Bain; Valérie Durieux; Konstantinos Triantafyllou; Nirav Thosani; Vincent Huberty; Shelby Sullivan

doi:10.1055/a-2292-2494

Endoscopy, Table of Contents

Endoscopy 2024; 56(06): 437-456
DOI: 10.1055/a-2292-2494

Guideline

American Society for Gastrointestinal Endoscopy–European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity

Pichamol Jirapinyo‡^‡

¹Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA

,

Alia Hadefi‡^‡

²Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Hôpital Universitaire de Bruxelles, Brussels, Belgium

,

Christopher C. Thompson

¹Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA

,

Árpád V. Patai

³Department of Surgery, Transplantation and Gastroenterology, Semmelweis University, Budapest, Hungary

,

Rahul Pannala

⁴Department of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona, USA

,

Stefan K. Goelder

⁵Department of Gastroenterology, University Hospital Augsburg, Augsburg, Germany

,

Vladimir Kushnir

⁶Department of Medicine-Division of Gastroenterology, Washington University, Washington University School of Medicine in St Louis, St Louis, Missouri, USA

,

Marc Barthet

⁷Department of Hepatogastroenterology, Faculty of Medicine, Aix-Marseille University, Chemin des Bourrely, Marseille, France

,

Caroline M. Apovian

⁸Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA

,

Ivo Boskoski

⁹Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, and Centre for Endoscopic Research Therapeutics and Training, Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy

,

Christopher G. Chapman

¹⁰Center for Interventional and Therapeutic Endoscopy, Division of Digestive Diseases and Nutrition, Rush University, Chicago, Illinois USA

,

Paul Davidson

¹¹Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA

,

Gianfranco Donatelli

¹²Unité d'Endoscopie Interventionnelle, Hôpital Privé des Peupliers, Ramsay Générale de Santé, Paris, France and Department of Clinical Medicine and Surgery, University of Naples "Federico II," Naples, Italy

,

Vivek Kumbhari

¹³Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA

,

Bu Hayee

¹⁴Division of Gastroenterology, Kings College London, London, United Kingdom

,

Janelle Esker

¹⁵Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, Colorado, USA

,

Tomas Hucl

¹⁶Department of Gastroenterology and Hepatology, Institute of Clinical and Experimental Medicine, Prague, Czech Republic

,

Aurora D. Pryor

¹⁷Department of Surgery, Long Island Jewish Medical Center, Queens, New York, USA

,

Roberta Maselli

¹⁸Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy and Humanitas Clinical and Research Center IRCCS, Endoscopy Unit, Rozzano, Italy

,

Allison R. Schulman

¹⁹Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA

,

Francois Pattou

²⁰Department of Endocrine and Metabolic Surgery, CHU Lille, University of Lille, Inserm, Institut Pasteur Lille, Lille, France

,

Shira Zelber-Sagi

²¹School of Public Health, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel and Department of Gastroenterology, Tel Aviv Medical Center, Tel Aviv, Israel

,

Paul A. Bain

²²Countway Library of Medicine, Harvard Medical School, Boston, Massachusetts, USA

,

Valérie Durieux

²³Bibliothèque des Sciences de la Santé, Université Libre de Bruxelles, Brussels, Belgium

,

Konstantinos Triantafyllou

²⁴Hepatogastroenterology Unit, Second Department of Internal Medicine-Propaedeutic, Medical School, National and Kapodistrian University of Athens, "Attikon" University General Hospital, Athens, Greece

,

Nirav Thosani

²⁵Center for Interventional Gastroenterology at UTHealth, Division of Gastroenterology Hepatology and Nutrition, McGovern Medical School, Houston, Texas, USA

,

Vincent Huberty‡^*

²Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Hôpital Universitaire de Bruxelles, Brussels, Belgium

,

Shelby Sullivan‡^*

¹⁵Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, Colorado, USA

› Author Affiliations

Abstract

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥30 kg/m², or with a BMI of 27.0–29.9 kg/m² with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

Full Text

References

References
1 Ellison-Barnes A, Johnson S, Gudzune K. Trends in obesity prevalence among adults aged 18 through 25 years, 1976-2018. JAMA 2021; 326: 2073-2074
2 Ward ZJ, Bleich SN, Cradock AL. et al. Projected U.S. state-level prevalence of adult obesity and severe obesity. N Engl J Med 2019; 381: 2440-2450
3 Roth GA, Abate KH, Abay SM. et al. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 2018; 392: 1736-1788
4 World Hhealth Organization. New WHO report: Europe can reverse its obesity “epidemic.”. 2022 Available at (Accessed 12/11/2022): https://easo.org/new-who-report-europe-can-reverse-its-obesity-epidemic/
5 Cousin E, Schmidt MI, Ong KL. et al. Burden of diabetes and hyperglycaemia in adults in the Americas, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Diabetes Endocrinol 2022; 10: 655-667
6 Younossi ZM. Non-alcoholic fatty liver disease – a global public health perspective. J Hepatol 2019; 70: 531-544
7 Estes C, Anstee QM, Arias-Loste MT. et al. Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030. J Hepatol 2018; 69: 896-904
8 World Obesity. World Obesity atlas 2022. Available at (Accessed 12/11/2022): https://www.worldobesityday.org/assets/downloads/World_Obesity_Atlas_2022_WEB.pdf
9 Berrington de Gonzalez A, Hartge P, Cerhan JR. et al. Body-mass index and mortality among 1.46 million white adults. N Engl J Med 2010; 363: 2211-2219
10 Jensen MD, Ryan DH, Apovian CM. et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation 2014; 129 (Suppl. 02) S102-S138
11 Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med 2010; 170: 1566-1575
12 Machado AM, Guimarães NS, Bocardi VB. et al. Understanding weight regain after a nutritional weight loss intervention: systematic review and meta-analysis. Clin Nutr ESPEN 2022; 49: 138-153
13 Wilding JPH, Batterham RL, Calanna S. et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med 2021; 384: 989-1002
14 Newsome PN, Buchholtz K, Cusi K. et al. A placebo-controlled trial of subcutaneous semaglutide in nonalcoholic steatohepatitis. N Engl J Med 2021; 384: 1113-1124
15 Marso SP, Bain SC, Consoli A. et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med 2016; 375: 1834-1844
16 Husain M, Birkenfeld AL, Donsmark M. et al. Oral semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med 2019; 381: 841-851
17 Grunvald E, Shah R, Hernaez R. et al. AGA clinical practice guideline on pharmacological interventions for adults with obesity. Gastroenterology 2022; 163: 1198-1225
18 Kalas MA, Galura GM, McCallum RW. Medication-Induced Gastroparesis: A Case Report. J Investig Med High Impact Case Rep 2021;
19 Peterli R, Wölnerhanssen BK, Peters T. et al. Effect of laparoscopic sleeve gastrectomy vs laparoscopic roux-en-y gastric bypass on weight loss in patients with morbid obesity: the SM-BOSS randomized clinical trial. JAMA 2018; 319: 255-265
20 Grönroos S, Helmiö M, Juuti A. et al. Effect of laparoscopic sleeve gastrectomy vs Roux-en-Y gastric bypass on weight loss and quality of life at 7 years in patients with morbid obesity: the SLEEVEPASS randomized clinical trial. JAMA Surg 2021; 156: 137-146
21 Schauer PR, Bhatt DL, Kirwan JP. et al. Bariatric surgery versus intensive medical therapy for diabetes—5-year outcomes. N Engl J Med 2017; 376: 641-651
22 Lassailly G, Caiazzo R, Ntandja-Wandji LC. et al. Bariatric surgery provides long-term resolution of nonalcoholic steatohepatitis and regression of fibrosis. Gastroenterology 2020; 159: 1290-1301
23 Lee Y, Doumouras AG, Yu J. et al. Complete resolution of nonalcoholic fatty liver disease after bariatric surgery: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2019; 17: 1040-1060
24 Campos GM, Khoraki J, Browning MG. et al. Changes in utilization of bariatric surgery in the united states from 1993 to 2016. Ann Surg 2020; 271: 201-209
25 Jirapinyo P, Thompson CC. Endoscopic bariatric and metabolic therapies: surgical analogues and mechanisms of action. Clin Gastroenterol Hepatol 2017; 15: 619-630
26 Hadefi A, Arvanitakis M, Huberty V. et al. Metabolic endoscopy: today's science—tomorrow's treatment. United Eur Gastroenterol J 2020; 8: 685-694
27 Aminian A, Zajichek A, Arterburn DE. et al. Association of metabolic surgery with major adverse cardiovascular outcomes in patients with type 2 diabetes and obesity. JAMA 2019; 322: 1271-1282
28 Gregg EW, Jakicic JM, Blackburn G. et al. Association of the magnitude of weight loss and changes in physical fitness with long-term cardiovascular disease outcomes in overweight or obese people with type 2 diabetes: a post-hoc analysis of the Look AHEAD randomised clinical trial. Lancet Diabetes Endocrinol 2016; 4: 913-921
29 Mingrone G, Panunzi S, De Gaetano A. et al. Metabolic surgery versus conventional medical therapy in patients with type 2 diabetes: 10-year follow-up of an open-label, single-centre, randomised controlled trial. Lancet 2021; 397: 293-304
30 Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L. et al. Weight loss through lifestyle modification significantly reduces features of nonalcoholic steatohepatitis. Gastroenterology 2015; 149: 367-378
31 Aminian A, Wilson R, Al-Kurd A. et al. Association of bariatric surgery with cancer risk and mortality in adults with obesity. JAMA 2022; 327: 2423-2433
32 Magkos F, Fraterrigo G, Yoshino J. et al. Effects of moderate and subsequent progressive weight loss on metabolic function and adipose tissue biology in humans with obesity. Cell Metab 2016; 23: 591-601
33 Bray GA, Culbert IW, Champagne CM. et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002; 346: 393-403
34 Wing RR, Espeland MA, Clark JM. et al. Association of weight loss maintenance and weight regain on 4-year changes in CVD risk factors: the Action for Health in Diabetes (Look AHEAD) clinical trial. Diabetes Care 2016; 39: 1345-1355
35 Rinella ME, Lazarus JV, Ratziu V. et al. A multi-society Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol 2023; 79: 1542-1556
36 Muniraj T, Day LW, Teigen LM. et al. AGA clinical practice guidelines on intragastric balloons in the management of obesity. Gastroenterology 2021; 160: 1799-1808
37 Ali MR, Moustarah F, Kim JJ. American Society for Metabolic and Bariatric Surgery position statement on intragastric balloon therapy endorsed by the Society of American Gastrointestinal and Endoscopic Surgeons. Surg Obes Relat Dis 2016; 12: 462-467
38 U.S. Food and Drug Administration. Endomina FDA approval. 2021 Accessed 09/06/2023
39 Abu Dayyeh BK, Maselli DB, Rapaka B. et al. Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial. Lancet 2021; 398: 1965-1973
40 Courcoulas A, Abu Dayyeh BK, Eaton L. et al. Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial. Int J Obes 2017; 41: 427-433
41 Fuller NR, Pearson S, Lau NS. et al. An intragastric balloon in the treatment of obese individuals with metabolic syndrome: a randomized controlled study. Obesity 2013; 21: 1561-1570
42 Ponce J, Quebbemann BB, Patterson EJ. Prospective, randomized, multicenter study evaluating safety and efficacy of intragastric dual-balloon in obesity. Surg Obes Relat Dis 2013; 9: 290-295
43 Ponce J, Woodman G, Swain J. et al. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis 2015; 11: 874-881
44 Sullivan S, Swain J, Woodman G. et al. Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss. Surg Obes Relat Dis 2018; 14: 1876-1889
45 Abu Dayyeh BK, Bazerbachi F, Vargas EJ. et al. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet 2022; 400: 441-451
46 Miller K, Turró R, Greve JW. et al. MILEPOST multicenter randomized controlled trial: 12-month weight loss and satiety outcomes after POSE (SM) vs. medical therapy. Obes Surg 2017; 27: 310-322
47 Sullivan S, Swain JM, Woodman G. et al. Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: the ESSENTIAL trial. Obesity 2017; 25: 294-301
48 Sullivan S, Stein R, Jonnalagadda S. et al. Aspiration therapy leads to weight loss in obese subjects: a pilot study. Gastroenterology 2013; 145: 1245-1252
49 Rothstein RI, Woodman G, Swain J. et al. Transpyloric shuttle treatment improves cardiometabolic risk factors and quality of life in patients with obesity: results from a randomized, double-blind, sham-controlled trial. Gastroenterology 2019; 156: S-237
50 Thompson CC, Jirapinyo P, Brethauer S. et al. A multicenter randomized sham-controlled trial of a duodenal jejunal bypass liner for the treatment of type 2 diabetes mellitus [abstract]. Gastrointest Endosc 2022; 95: AB10-A11
51 Ruban A, Miras AD, Glaysher MA. et al. Duodenal-jejunal bypass liner for the management of type 2 diabetes mellitus and obesity: a multicenter randomized controlled trial. Ann Surg 2022; 275: 440-447
52 Thompson CC, Abu Dayyeh BK, 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: 447-457
53 Clavien PA, Barkun J, de Oliveira ML. et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg 2009; 250: 187-196
54 Wallace B, Small K, Brodley C. et al. Deploying an Interactive Machine Learning System in an Evidence-based Practice Center: Abstract. Proceedings of the 2nd ACM SIGHIT International Health Informatics Symposium. 2012
55 Fittipaldi-Fernandez RJ, Zotarelli-Filho IJ, Diestel CF. et al. Intragastric balloon: a retrospective evaluation of 5874 patients on tolerance, complications, and efficacy in different degrees of overweight. Obes Surg 2020; 30: 4892-4898
56 Moore RL, Seger MV, Garber SM. et al. Clinical safety and effectiveness of a swallowable gas-filled intragastric balloon system for weight loss: consecutively treated patients in the initial year of U.S. commercialization. Surg Obes Relat Dis 2019; 15: 417-423
57 Barrichello S, Hourneaux de Moura DT, Hourneaux de Moura EG. et al. Endoscopic sleeve gastroplasty in the management of overweight and obesity: an international multicenter study. Gastrointest Endosc 2019; 90: 770-780
58 Laubner K, Riedel N, Fink K. et al. Comparative efficacy and safety of the duodenal-jejunal bypass liner in obese patients with type 2 diabetes mellitus: a case control study. Diabetes Obes Metab 2018; 20: 1868-1877
59 Betzel B, Koehestanie P, Homan J. et al. Changes in glycemic control and body weight after explantation of the duodenal-jejunal bypass liner. Gastrointest Endosc 2017; 85: 409-415
60 Cohen RV, Neto MG, Correa JL. et al. A pilot study of the duodenal-jejunal bypass liner in low body mass index type 2 diabetes. J Clin Endocrinol Metab 2013; 98: E279-E282
61 Konopko-Zubrzycka M, Baniukiewicz A, Wroblewski E. et al. The effect of intragastric balloon on plasma ghrelin, leptin, and adiponectin levels in patients with morbid obesity. J Clin Endocrinol Metab 2009; 94: 1644-1649
62 Huberty V, Boskoski I, Bove V. et al. Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial. Gut 2021; 70: 1479-1485
63 Koehestanie P, de Jonge C, 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: 984-992
64 Mingrone G, van Baar AC, Devière J. et al. Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial. Gut 2022; 71: 254-264
65 Khan O, Irukulla S, Sanmugalingam N. et al. Simultaneous intra-gastric balloon removal and laparoscopic sleeve gastrectomy for the super-super obese patients – a prospective feasibility study. Obes Surg 2013; 23: 585-587
66 Zerrweck C, Maunoury V, Caiazzo R. et al. Preoperative weight loss with intragastric balloon decreases the risk of significant adverse outcomes of laparoscopic gastric bypass in super-super obese patients. Obes Surg 2012; 22: 777-782
67 Gottig S, Daskalakis M, Weiner S. et al. Analysis of safety and efficacy of intragastric balloon in extremely obese patients. Obes Surg 2009; 19: 677-683
68 Spyropoulos C, Katsakoulis E, Mead N. et al. Intragastric balloon for high-risk super-obese patients: a prospective analysis of efficacy. Surg Obes Relat Dis 2007; 3: 78-83
69 Mohamed ZK, Kalbassi MR, Boyle M. et al. Intra-gastric balloon therapy and weight reduction. Surgeon 2008; 6: 210-212
70 Frutos MD, Morales MD, Luján J. et al. Intragastric balloon reduces liver volume in super-obese patients, facilitating subsequent laparoscopic gastric bypass. Obes Surg 2007; 17: 150-154
71 Alfalah H, Philippe B, Ghazal F. et al. Intragastric balloon for preoperative weight reduction in candidates for laparoscopic gastric bypass with massive obesity. Obes Surg 2006; 16: 147-150
72 Busetto L, Enzi G, Inelmen EM. et al. Obstructive sleep apnea syndrome in morbid obesity: effects of intragastric balloon. Chest 2005; 128: 618-623
73 Busetto L, Segato G, De Luca M. et al. Preoperative weight loss by intragastric balloon in super-obese patients treated with laparoscopic gastric banding: a case-control study. Obes Surg 2004; 14: 671-676
74 Lopez Nava G, Arau RT, Asokkumar R. et al. Prospective multicenter study of the primary obesity surgery endoluminal (POSE 2.0) procedure for treatment of obesity. Clin Gastroenterol Hepatol 2023; 21: 81-89
75 Nystrom M, Machytka E, Noren E. et al. Aspiration therapy as a tool to treat obesity: 1- to 4-year results in a 201-patient multi-center post-market European registry study. Obes Surg 2018; 28: 1860-1868
76 Obermayer A, Tripolt NJ, Aziz F. et al. EndoBarrier implantation rapidly improves insulin sensitivity in obese individuals with type 2 diabetes mellitus. Biomolecules 2021; 11: 574
77 Roehlen N, Laubner K, Bettinger D. et al. Duodenal-jejunal bypass liner (DJBL) improves cardiovascular risk biomarkers and predicted 4-year risk of major CV events in patients with type 2 diabetes and metabolic syndrome. Obes Surg 2020; 30: 1200-1210
78 Deutsch L, Ben Haim L, Sofer Y. et al. Long-term effects of proximal small bowel exclusion by duodenal-jejunal bypass liner on weight reduction and glycemic control in diabetic patients. Surg Obes Relat Dis 2018; 14: 1561-1569
79 Patel N, Mohanaruban A, Ashrafian H. et al. EndoBarrier(R): a safe and effective novel treatment for obesity and type 2 diabetes?. Obes Surg 2018; 28: 1980-1989
80 Quezada N, Munoz R, Morelli C. et al. Safety and efficacy of the endoscopic duodenal-jejunal bypass liner prototype in severe or morbidly obese subjects implanted for up to 3 years. Surg Endosc 2018; 32: 260-267
81 Gollisch KS, Lindhorst A, Raddatz D. EndoBarrier gastrointestinal liner in type 2 diabetic patients improves liver fibrosis as assessed by liver elastography. Exp Clin Endocrinol Diabetes 2017; 125: 116-121
82 Stratmann B, Krepak Y, Schiffer E. et al. Beneficial metabolic effects of duodenal jejunal bypass liner for the treatment of adipose patients with type 2 diabetes mellitus: analysis of responders and non-responders. Horm Metab Res 2016; 48: 630-637
83 de Moura EG, Martins BC, Lopes GS. et al. Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technol Ther 2012; 14: 183-189
84 Rodriguez L, Reyes E, Fagalde P. et al. Pilot clinical study of an endoscopic, removable duodenal-jejunal bypass liner for the treatment of type 2 diabetes. Diabetes Technol Ther 2009; 11: 725-732
85 Nunes GC, Pajecki D, de Melo ME. et al. Assessment of weight loss with the intragastric balloon in patients with different degrees of obesity. Surg Laparosc Endosc Percutan Tech 2017; 27: e83-e86
86 Kirkpatrick CF, Bolick JP, Kris-Etherton PM. et al. Review of current evidence and clinical recommendations on the effects of low-carbohydrate and very-low-carbohydrate (including ketogenic) diets for the management of body weight and other cardiometabolic risk factors: a scientific statement from the National Lipid Association Nutrition and Lifestyle Task Force. J Clin Lipidol 2019; 13: 689-711
87 Saumoy M, Gandhi D, Buller S. et al. Cost-effectiveness of endoscopic, surgical and pharmacological obesity therapies: a microsimulation and threshold analyses. Gut 2023; 72: 2250-2259
88 Kelly J, Menon V, O'Neil F. et al. UK cost-effectiveness analysis of endoscopic sleeve gastroplasty versus lifestyle modification alone for adults with class II obesity. Int J Obes (Lond) 2023; 47: 1161-1170
89 Haseeb M, Waqar M, Jirapinyo P. et al. Cost-effectiveness Analysis of Endoscopic Sleeve Gastroplasty Compared to Semaglutide for Weight Loss in Patients with Obesity. GIE – Gastrointestinal Endoscopy 2023; 97: AB21
90 Shah R, Davitkov P, Abu Dayyeh BK. et al. AGA technical review on intragastric balloons in the management of obesity. Gastroenterology 2021; 160: 1811-1830
91 Vicente Martin C, Rabago Torre LR, Castillo Herrera LA. et al. Preoperative intragastric balloon in morbid obesity is unable to decrease early postoperative morbidity of bariatric surgery (sleeve gastrectomy and gastric bypass): a clinical assay. Surg Endosc 2020; 34: 2519-2531
92 Benjamin SB, Maher KA, Cattau JrEL. et al. Double-blind controlled trial of the Garren-Edwards gastric bubble: an adjunctive treatment for exogenous obesity. Gastroenterology 1988; 95: 581-588
93 Hogan RB, Johnston JH, Long BW. et al. A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity. Gastrointest Endosc 1989; 35: 381-385
94 Benjamin SB. Small bowel obstruction and the Garren-Edwards gastric bubble: an iatrogenic bezoar. Gastrointest Endosc 1988; 34: 463-467
95 Geliebter A, Westreich S, Gage D. Gastric distention by balloon and test-meal intake in obese and lean subjects. Am J Clin Nutr 1988; 48: 592-594
96 Gómez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: results of a prospective study. Obesity 2016; 24: 1849-1853
97 Swei E, Spiel A, Sullivan S. et al. Effect of blinding on weight loss in patients undergoing intragastric balloon placement: a systematic review and meta-analysis. Am J Gastroenterol 2021; 116: S84
98 Genco A, Cipriano M, Bacci V. et al. Intragastric balloon followed by diet vs intragastric balloon followed by another balloon: a prospective study on 100 patients. Obes Surg 2010; 20: 1496-1500
99 Genco A, Maselli R, Frangella F. et al. Effect of consecutive intragastric balloon (BIB) plus diet versus single BIB plus diet on eating disorders not otherwise specified (EDNOS) in obese patients. Obes Surg 2013; 23: 2075-2079
100 Carr P, Keighley T, Petocz P. et al. Efficacy and safety of endoscopic sleeve gastroplasty and laparoscopic sleeve gastrectomy with 12+ months of adjuvant multidisciplinary support. BMC Primary Care 2022; 23: 26
101 Li R, Veltzke-Schlieker W, Adler A. et al. Endoscopic sleeve gastroplasty (ESG) for high-risk patients, high body mass index (> 50 kg/m2) patients, and contraindication to abdominal surgery. Obesity Surgery 2021; 31: 3400-3409
102 Badurdeen D, Hoff AC, Hedjoudje A. et al. Endoscopic sleeve gastroplasty plus liraglutide versus endoscopic sleeve gastroplasty alone for weight loss. Gastrointest Endosc 2021; 93: 1316-1324
103 Jagtap N, Kalapala R, Katakwar A. et al. Endoscopic sleeve gastroplasty--minimally invasive treatment for non-alcoholic fatty liver disease and obesity. Indian J Gastroenterol 2021; 40: 572-579
104 Pizzicannella M, Lapergola A, Fiorillo C. et al. Does endoscopic sleeve gastroplasty stand the test of time? Objective assessment of endoscopic ESG appearance and its relation to weight loss in a large group of consecutive patients. Surg Endosc 2020; 34: 3696-3705
105 Farha J, McGowan C, Hedjoudje A. et al. Endoscopic sleeve gastroplasty: suturing the gastric fundus does not confer benefit. Endoscopy 2021; 53: 727-731
106 Boskoski I, Pontecorvi V, Gallo C. et al. Redo endoscopic sleeve gastroplasty: technical aspects and short-term outcomes. Ther Adv Gastroenterol 2020; 13: 1-6
107 Bhandari M, Jain S, Mathur W. et al. Endoscopic sleeve gastroplasty is an effective and safe minimally invasive approach for treatment of obesity: first Indian experience. Digestive Endoscopy 2020; 32: 541-546
108 James TW, Reddy Sm, Vulpis T. et al. Endoscopic sleeve gastroplasty is feasible, safe, and effective in a non-academic setting: short-term outcomes from a community gastroenterology practice. Obes Surg 2020; 30: 1404-1409
109 Galvao NetoM, Moon RC, de Quadros LG. et al. Safety and short-term effectiveness of endoscopic sleeve gastroplasty using overstitch: preliminary report from a multicenter study. Surg Endosc 2020; 34: 4388-4394
110 Lopez-Nava G, Asokkumar R, Rull A. et al. Bariatric endoscopy procedure type or follow-up: what predicted success at 1 year in 962 obese patients?. Endosc Int Open 2019; 07: E1691-E1698
111 Kumar N, Abu Dayyeh BK, Lopez-Nava G. et al. Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique. Surg Endosc 2018; 32: 2159-2164
112 Graus Morales J, Perez LC, Marques A. et al. Modified endoscopic gastroplasty for the treatment of obesity. Surg Endosc 2018; 32: 3936-3942
113 Jirapinyo P, Thompson CC. Comparison of distal primary obesity surgery endolumenal techniques for the treatment of obesity (with videos). Gastrointest Endosc 2022; 96: 479-486
114 Espinos JC, Turro R, Moragas G. et al. Gastrointestinal physiological changes and their relationship to weight loss following the POSE procedure. Obes Surg 2016; 26: 1081-1089
115 Lopez-Nava G, Bautista-Castano I, Jimenez A. et al. The primary obesity surgery endolumenal (POSE) procedure: one-year patient weight loss and safety outcomes. Surg Obes Relat Dis 2015; 11: 861-865
116 Huberty V, Machytka E, Boskoski I. et al. Endoscopic gastric reduction with an endoluminal suturing device: a multicenter prospective trial with 1-year follow-up. Endoscopy 2018; 50: 1156-1162
117 Abdelhamid SA, Kamel MS. A prospective controlled study to assess the antiemetic effect of midazolam following intragastric balloon insertion. J Anaesthesiol Clin Pharmacol 2014; 30: 383-386
118 Van Hee R, Van Wiemeersch S, Lasters B. et al. Use of anti-emetics after intragastric balloon placement: experience with three different drug treatments. Obes Surg 2003; 13: 932-937
119 Weibel S, Rücker G, Eberhart LH. et al. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis. Cochrane Database Syst Rev 2020; 10: Cd012859
120 Nuttall GA, Voogd SC, Danke H. et al. The incidence of torsades de pointes with peri-operative low-dose ondansetron administration. Pharmacotherapy 2022; 42: 292-297
121 Abu Dayyeh BK, Kumar N, Edmundowicz SA. et al. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc 2015; 82: 425-438
122 Smith ME, Lee JS, Bonham A. et al. Effect of new persistent opioid use on physiologic and psychologic outcomes following bariatric surgery. Surg Endosc 2019; 33: 2649-2656
123 Vargas EJ, Rizk M, Gomez-Villa J. et al. Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study. Gut 2023; 72: 1073-1080
124 Espinós JC, Turró R, Moragas G. et al. Gastrointestinal physiological changes and their relationship to weight loss following the POSE procedure. Obes Surg 2016; 26: 1081-1089
125 Bratzler DW, Dellinger EP, Olsen KM. et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm 2013; 70: 195-283
126 Jirapinyo P, Kumar N, Saumoy M. et al. Association for Bariatric Endoscopy systematic review and meta-analysis assessing the American Society for Gastrointestinal Endoscopy Preservation and Incorporation of Valuable Endoscopic Innovations thresholds for aspiration therapy. Gastrointest Endosc 2021; 93: 334-342
127 Marinos G, Eliades C, Raman Muthusamy V. et al. Weight loss and improved quality of life with a nonsurgical endoscopic treatment for obesity: clinical results from a 3- and 6-month study. Surg Obes Relat Dis 2014; 10: 929-934
128 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 meta-analysis with secondary analysis on weight loss and hormonal changes. Diabetes Care 2018; 41: 1106-1115
129 Fang M, Wang D, Coresh J. et al. Trends in diabetes treatment and control in U.S. adults, 1999–2018. N Engl J Med 2021; 384: 2219-2228
130 de Oliveira GHP, de Moura DTH, Funari MP. et al. Metabolic effects of endoscopic duodenal mucosal resurfacing: a systematic review and meta-analysis. Obes Surg 2021; 31: 1304-1312
131 van Baar ACG, Holleman F, Crenier L. et al. Endoscopic duodenal mucosal resurfacing for the treatment of type 2 diabetes mellitus: one year results from the first international, open-label, prospective, multicentre study. Gut 2020; 69: 295-303
132 Hadefi A, Verset L, Pezzullo M. et al. Endoscopic duodenal mucosal resurfacing for nonalcoholic steatohepatitis (NASH): a pilot study. Endosc Int Open 2021; 9: E1792-E1800
133 Sharaiha RZ, Hajifathalian K, Kumar R. et al. Five-year outcomes of endoscopic sleeve gastroplasty for the treatment of obesity. Clin Gastroenterol Hepatol 2021; 19: 1051-1057
134 Alqahtani AR, Elahmedi M, Aldarwish A. et al. Endoscopic gastroplasty versus laparoscopic sleeve gastrectomy: a noninferiority propensity score-matched comparative study. Gastrointest Endosc 2022; 96: 44-50
135 Apovian CM, Aronne LJ, Bessesen DH. et al. Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology & Metabolism 2015; 100: 342-362
136 Eisenberg D, Shikora SA, Aarts E. et al. 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): indications for metabolic and bariatric surgery. Surg Obes Relat Dis 2022; 18: 1345-1356

Supplementary Material

Supplementary material