Endoscopic sleeve gastroplasty in the management of overweight and obesity: an international multicenter study

      Background and Aims

      Obesity is a pandemic affecting approximately 700 million adults worldwide, with an additional 2 billion overweight. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic bariatric therapy that involves remodeling of the greater curvature in an effort to reduce gastric capacity and delay gastric emptying. A variety of ESG suture patterns has been reported. This study is the first to use a uniform “U” stitch pattern across all centers to simplify technical aspects of the procedure and limit cost. This also uniquely assessed outcomes in all body mass index (BMI) categories and changes in metabolic rate, lean body mass, and adipose tissue composition.

      Methods

      This is a multicenter analysis of prospectively collected data from 7 centers including patients with overweight and obesity who underwent ESG. Primary outcomes included absolute weight loss, percent total body weight loss (%TWL), change in BMI, and percent excess weight loss (%EWL) at 6 and 12 months in overweight and obese classes I, II, and III. Secondary outcomes included adipose tissue, lean body mass reduction, and metabolic rate analyzed by bioimpedance. Additionally, immediate or delayed adverse events (AEs) were analyzed. Clinical success was defined as achieving ≥25% EWL at 1 year with ≤5% serious AE (SAE) rate following the American Society for Gastrointestinal Endoscopy (ASGE)/American Society for Metabolic and Bariatric Surgery (ASMBS) threshold.

      Results

      A total of 193 patients underwent ESG during the study period. All groups had >10% TWL and >25% EWL at 6 months of follow-up. On average, %TWL was 14.25% ± 5.26% and 15.06% ± 5.22% and the %EWL 56.15% ± 22.93% and 59.41% ± 25.69% at 6 months and 1 year of follow-up, respectively. %TWL was 8.91% ± .3%, 13.92% ± 5.76%, 16.22% ± 7.69%, and 19.01% ± .95% and %EWL 56.21% ± 2.0%, 62.03% ± 27.63%, 54.13% ± 23.46%, and 46.78% ± 2.43% for overweight and obesity classes I, II, and III, respectively, at 1 year. Male sex, age <41 years, and higher BMI were predictors of achieving a TWL ≥10% at 1-year follow-up. There was a significant reduction in adipose tissue from baseline. SAEs occurred in 1.03%, including 2 perigastric collections needing surgery.

      Conclusions

      ESG appears to be feasible, safe, and effective in the treatment of patients with overweight and obesity according to ASGE/ASMBS thresholds.

      Graphical abstract

      Abbreviations:

      AE (adverse event), ASGE (American Society for Gastrointestinal Endoscopy), ASMBS (American Society for Metabolic and Bariatric Surgery), AWL (absolute weight loss), BMI (body mass index), EBT (endoscopic bariatric therapy), ESG (endoscopic sleeve gastroplasty), %EWL (percent excess weight loss), SAE (serious adverse event), %TWL (percent total body weight loss)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Gastrointestinal Endoscopy
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • World Health Organization
        Obesity and overweight factsheet.
        (Available at:) (Accessed December 10, 2018)
        • Rønningen R.
        • Wammer A.C.P.
        • Grabner N.H.
        • et al.
        Associations between lifetime adversity and obesity treatment in patients with morbid obesity.
        Obes Facts. 2019; 12: 1-13
        • Ruiz-Cota P.
        • Bacardí-Gascón M.
        • Jiménez-Cruz A.
        Long-term outcomes of metabolic and bariatric surgery in adolescents with severe obesity with a follow-up of at least 5 years: a systematic review.
        Surg Obes Relat Dis. 2019; 15: 133-144
        • Khosravi-Largani M.
        • Nojomi M.
        • Aghili R.
        • et al.
        Evaluation of all types of metabolic bariatric surgery and its consequences: a systematic review and meta-analysis.
        Obes Surg. 2019; 29: 651-690
        • Barrichello S.
        • Minata M.K.
        • García Ruiz de Gordejuela A.
        • et al.
        Laparoscopic greater curvature plication and laparoscopic sleeve gastrectomy treatments for obesity: systematic review and meta-analysis of short- and mid-term results.
        Obes Surg. 2018; 28: 3199-3212
        • Flum D.R.
        • Belle S.H.
        • King W.C.
        • et al.
        Perioperative safety in the longitudinal assessment of bariatric surgery.
        N Engl J Med. 2009; 361: 445-454
        • Obeid N.R.
        • Malick W.
        • Concors S.J.
        • et al.
        Long-term outcomes after Roux-en-Y gastric bypass: 10- to 13-year data.
        Surg Obes Relat Dis. 2016; 12: 11-20
        • Haito-Chavez Y.
        • Kumbhari V.
        • Ngamruengphong S.
        • et al.
        Septotomy: an adjunct endoscopic treatment for post-sleeve gastrectomy fistulas.
        Gastrointest Endosc. 2016; 83: 456-457
        • Buchwald H.
        • Oien D.M.
        Metabolic/bariatric surgery worldwide 2011.
        Obes Surg. 2013; 23: 427-436
        • Madruga-Neto A.C.
        • Bernardo W.M.
        • de Moura D.T.H.
        • et al.
        The effectiveness of endoscopic gastroplasty for obesity treatment according to FDA thresholds: systematic review and meta-analysis based on randomized controlled trials.
        Obes Surg. 2018; 28: 2932-2940
        • Moura D.
        • Oliveira J.
        • De Moura E.G.
        • et al.
        Effectiveness of intragastric balloon for obesity: a systematic review and meta-analysis based on randomized control trials.
        Surg Obes Relat Dis. 2016; 12: 420-429
        • Bustamante F.
        • Brunaldi V.O.
        • Bernardo W.M.
        • et al.
        Obesity treatment with botulinum toxin-A is not effective: a systematic review and meta-analysis.
        Obes Surg. 2017; 27: 2716-2723
        • Brunaldi V.O.
        • Jirapinyo P.
        • de Moura D.T.H.
        • et al.
        Endoscopic treatment of weight regain following Roux-en-Y gastric bypass: a systematic review and meta-analysis.
        Obes Surg. 2018; 28: 266-276
        • Lopez-Nava G.
        • Galvao M.P.
        • Bautista-Castano I.
        • et al.
        Endoscopic sleeve gastroplasty: how I do it?.
        Obes Surg. 2015; 25: 1534-1538
        • Kumar N.
        • Lopez-Nava G.
        • Sahdala H.N.P.
        • et al.
        Endoscopic sleeve gastroplasty: multicenter weight loss results.
        Gastroenterology. 2015; 148: S179
        • Brethauer S.A.
        • Chand B.
        • Schauer P.R.
        • et al.
        Transoral gastric volume reduction for weight management: technique and feasibility in 18 patients.
        Surg Obes Relat Dis. 2010; 6: 689-694
        • Brethauer S.A.
        • Chand B.
        • Schauer P.R.
        • et al.
        Transoral gastric volume reduction as intervention for weight management: 12-month follow-up of TRIM trial.
        Surg Obes Relat Dis. 2012; 8: 296-303
        • Lopez-Nava G.
        • Sharaiha R.Z.
        • Vargas E.J.
        • et al.
        Endoscopic sleeve gastroplasty for obesity: a multicenter study of 248 patients with 24 months follow-up.
        Obes Surg. 2017; 27: 2649-2655
        • Sharaiha R.Z.
        • Kedia P.
        • Kumta N.
        • et al.
        Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population.
        Endoscopy. 2015; 47: 164-166
        • Lopez-Nava G.
        • Galvao M.P.
        • da Bautista-Castano I.J.
        • et al.
        Endoscopic sleeve gastroplasty for the treatment of obesity.
        Endoscopy. 2015; 47: 449-452
        • de Moura D.T.H.
        • de Moura E.G.H.
        • Thompson C.C.
        Endoscopic sleeve gastroplasty: from whence we came and where we are going.
        World J Gastrointest Endosc. 2019; 11: 322-328
        • Abu Dayyeh B.K.
        • Acosta A.
        • Camilleri M.
        • et al.
        Endoscopic sleeve gastroplasty alters gastric physiology and induces loss of body weight in obese individuals.
        Clin Gastroenterol Hepatol. 2017; 15: 37-43
        • Sharaiha R.Z.
        • Kumta N.A.
        • Saumoy M.
        • et al.
        Endoscopic sleeve gastroplasty significantly reduces body mass index and metabolic complications in obese patients.
        Clin Gastroenterol Hepatol. 2017; 15: 504-510
        • Alqahtani A.
        • Al-Darwish A.
        • Mahmoud A.E.
        • et al.
        Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients.
        Gastrointest Endosc. 2019; 89: 1132-1138
        • Cotton P.B.
        • Eisen G.M.
        • Aabakken L.
        • et al.
        A lexicon for endoscopic adverse events: report of an ASGE workshop.
        Gastrointest Endosc. 2010; 71: 446-454
        • Abu Dayyeh B.K.
        • Kumar N.
        • Edmundowicz S.A.
        • et al.
        • ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee
        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
        • ASGE/ASMBS Task Force on Endoscopic Bariatric Therapy
        A pathway to endoscopic bariatric therapies.
        Surg Obes Relat Dis. 2011; 7: 672-682
        • Neto M.G.
        • Silva L.B.
        • Grecco E.
        • et al.
        Brazilian Intragastric Balloon Consensus Statement (BIBC): practical guidelines based on experience of over 40,000 cases.
        Surg Obes Relat Dis. 2018; 14: 151-159
        • Fogel R.
        • De Fogel J.
        • Bonilla Y.
        • et al.
        Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients.
        Gastrointest Endosc. 2008; 68: 51-58
      1. Neto MG, Zundel N, Campos JM, et al. ET010 endoluminal greater curvature plication—a case series [Abstract]. SAGES. Available at: https://www.sages.org/meetings/annual-meeting/abstracts-archive/endoluminal-greater-curvature-plication-a-case-series/.

        • Kumar N.
        • Abu Dayyeh B.K.
        • Lopez-Nava Breviere G.
        • et al.
        Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique.
        Surg Endosc. 2018; 32: 2159-2164
        • Graus Morales J.
        • Crespo Perez L.
        • Marques A.
        • et al.
        Modified endoscopic gastroplasty for the treatment of obesity.
        Surg Endosc. 2018; 32: 3936-3942
        • Jain D.
        • Bhandari B.S.
        • Arora A.
        • et al.
        Endoscopic sleeve gastroplasty—a new tool to manage obesity.
        Clin Endosc. 2017; 50: 552-561
        • 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
        • Daniel S.
        • Soleymani T.
        • Garvey W.T.
        A complications-based clinical staging of obesity to guide treatment modality and intensity.
        Curr Opin Endocrinol Diabetes Obes. 2013; 20: 377-388
        • Action for Health in Diabetes Study Group
        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
        • Courcoulas A.
        • Abu Dayyeh B.K.
        • Eaton L.
        • et al.
        Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial.
        Int J Obes. 2017; 41: 427-433
        • Lopez-Nava G.
        • Galvão M.P.
        • Bautista-Castaño I.
        • et al.
        Endoscopic sleeve gastroplasty for obesity treatment: two years of experience.
        Arq Bras Cir Dig. 2017; 30: 18-20
        • Mehran A.
        Comment on the REDUCE trial article: Is it really as good as it sounds?.
        Surg Obes Relat Dis. 2016; 12: 217
        • Sartoretto A.
        • Sui Z.
        • Hill C.
        • et al.
        Endoscopic sleeve gastroplasty (ESG) is a reproducible and effective endoscopic bariatric therapy suitable for widespread clinical adoption: a large, international multicenter study.
        Obes Surg. 2018; 28: 1812-1821
        • Reimão S.M.
        • da Silva M.E.R.
        • Nunes G.C.
        • et al.
        Improvement of body composition and quality of life following intragastric balloon.
        Obes Surg. 2018; 28: 1806-1808
        • Bužga M.
        • Švagera Z.
        • Tomášková H.
        • et al.
        Metabolic effects of sleeve gastrectomy and laparoscopic greater curvature plication: an 18-month prospective, observational, open-label study.
        Obes Surg. 2017; 27: 3258-3266
        • Saumoy M.
        • Schneider Y.
        • Zhou X.K.
        • et al.
        A single-operator learning curve analysis for the endoscopic sleeve gastroplasty.
        Gastrointest Endosc. 2018; 87: 442-447
        • Jain D.
        • Bhandari B.S.
        • Arora A.
        • et al.
        Endoscopic sleeve gastroplasty—a new tool to manage obesity.
        Clin Endosc. 2017; 50: 552-561
        • Barola S.
        • Agnihotri A.
        • Khashab M.A.
        • et al.
        Perigastric fluid collection after endoscopic sleeve gastroplasty.
        Endoscopy. 2016; 48: E340-E341
        • Trastulli S.
        • Desiderio J.
        • Guarino S.
        • et al.
        Laparoscopic sleeve gastrectomy compared with other bariatric surgical procedures: a systematic review of randomized trials.
        Surg Obes Relat Dis. 2013; 9: 816-829
        • Baptista A.
        • Hourneaux De Moura D.T.
        • et al.
        Efficacy of the cardiac septal occluder in the treatment of post-bariatric surgery leaks and fistulas.
        Gastrointest Endosc. 2019; 89: 671-679
        • Sakran N.
        • Sherf-Dagan S.
        • Blumenfeld O.
        • et al.
        Incidence and risk factors for mortality following bariatric surgery: a nationwide registry study.
        Obes Surg. 2018; 28: 2661-2669

      Linked Article

      • Making a U-turn at the stomach
        Gastrointestinal EndoscopyVol. 90Issue 5
        • Preview
          Our world is amidst a crucial overweight and obesity pandemic that continues to grow, with 2 billion of the world’s population overweight and approximately 700 million adults with obesity.1 Once thought to be a disease of the rich and affluent, weight-related and metabolic diseases are on the rise across all socioeconomic classes and residential settings. The enduring physiologic and hormonal changes that occur with weight gain make sustainable weight loss with just diet and exercise, commonly known as lifestyle modification, not feasible for most people.
        • Full-Text
        • PDF