Efficacy and Safety of Endoscopic Gastroplasty versus Lifestyle Modification for Obesity: A Meta-Analysis of Randomized Controlled Trials with Technique-Specific Subgroup Analysis

Nitin Jagtap; Aman Golchha; Saransh Jain; Ivo Boskoski; Vincent Huberty; Rakesh Kalapala; D. Nageshwar Reddy

doi:10.1055/s-0045-1811546

Journal of Digestive Endoscopy, Table of Contents

CC BY 4.0 · Journal of Digestive Endoscopy
DOI: 10.1055/s-0045-1811546

Original Article

Efficacy and Safety of Endoscopic Gastroplasty versus Lifestyle Modification for Obesity: A Meta-Analysis of Randomized Controlled Trials with Technique-Specific Subgroup Analysis

Authors

Nitin Jagtap

¹Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
Aman Golchha

¹Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
Saransh Jain

²Consultant Gastroenterologist, Jainamshree Multi-Speciality Hospital, Bhopal, Madhya Pradesh, India
Ivo Boskoski

³Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
Vincent Huberty

⁴Medical-Surgical Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium
Rakesh Kalapala

¹Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
D. Nageshwar Reddy

¹Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India

Abstract

Background

Endoscopic gastroplasty (EG) offers a minimally invasive alternative to bariatric surgery for obesity management. While multiple randomized controlled trials (RCTs) have compared EG with lifestyle modification (LM), the extent of benefit and influence of procedural technique remain uncertain.

Materials and Methods

We conducted a meta-analysis restricted to RCTs comparing EG with LM in adults with obesity. The primary outcome was total body weight loss (TBWL) at 12 months. Secondary outcomes included TBWL and excess weight loss (EWL) at 6 months, and EWL at 12 months. Pooled mean differences (MDs) were estimated using a random-effects model. Subgroup analyses were performed based on techniques, such as OverStitch ESG, Endomina, and Primary Obesity Surgery Endoluminal (POSE). Trial sequential analysis (TSA) and assessment of adverse events and publication bias were also conducted.

Results

Five RCTs involving 696 participants were included. EG resulted in significantly greater TBWL at 12 months compared to LM (MD: 7.67%; 95% confidence interval [CI]: 4.38–10.96; I ² = 92.5%). TSA confirmed the conclusiveness of this finding. EG also led to superior TBWL at 6 months (MD: 6.98%; 95% CI: 3.76–10.20) and greater EWL at 6 months (MD: 24.85%; 95% CI: 13.44–36.27) and 12 months (MD: 26.24%; 95% CI: 11.19–41.29). Subgroup analysis showed highest efficacy with OverStitch ESG (MD: 10.82%), followed by Endomina (6.50%) and POSE (5.61%). The pooled incidence of any adverse event was 10.8%, while serious adverse events were rare (2.9%).

Conclusion

EG is more effective than LM for weight loss at 6 and 12 months, with an acceptable safety profile. Among techniques, OverStitch ESG demonstrated the highest efficacy. These findings support the incorporation of EG into the obesity treatment algorithm, especially for patients unsuitable for surgery.

Keywords

endoscopic gastroplasty - obesity treatment - lifestyle modification - randomized controlled trials - weight loss - OverStitch - Endomina - POSE

Full Text

References

References
1 Sturgiss EA, Haesler E, Elmitt N, Douglas K. Obesity management in primary care. Lancet 2017; 389 (10079): 1605
2 Bray GA, Frühbeck G, Ryan DH, Wilding JP. Management of obesity. Lancet 2016; 387 (10031): 1947-1956
3 Wadden TA, Tronieri JS, Butryn ML. Lifestyle modification approaches for the treatment of obesity in adults. Am Psychol 2020; 75 (02) 235-251
4 Schauer PR, Bhatt DL, Kirwan JP. et al; STAMPEDE Investigators. Bariatric surgery versus intensive medical therapy for diabetes - 5-year outcomes. N Engl J Med 2017; 376 (07) 641-651
5 Lopez-Nava G, Sharaiha RZ, Vargas EJ. et al. Endoscopic sleeve gastroplasty for obesity: a multicenter study of 248 patients with 24 months follow-up. Obes Surg 2017; 27 (10) 2649-2655
6 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 (06) 572-579
7 Maydeo A, Patil G, Dalal A, Thakare S, Iyer A, Patil N. An Indian experience of endoscopic treatment of obesity by using a novel technique of endoscopic sleeve gastroplasty (accordion procedure). J Assoc Physicians India 2020; 68 (08) 14-17
8 Abad J, Llop E, Arias-Loste MT. et al. Endoscopic sleeve gastroplasty plus lifestyle intervention in patients with MASH: a multicentre, sham-controlled, randomized trial. Clin Gastroenterol Hepatol 2025; 23 (09) 1556-1566
9 Abu Dayyeh BK, Bazerbachi F, Vargas EJ. et al; MERIT Study Group. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet 2022; 400 (10350): 441-451
10 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 (Silver Spring) 2017; 25 (02) 294-301
11 Miller K, Turró R, Greve JW, Bakker CM, Buchwald JN, Espinós JC. Medical Therapy. MILEPOST multicenter randomized controlled trial: 12-month weight loss and satiety outcomes after pose ^SM vs. medical therapy. Obes Surg 2017; 27 (02) 310-322
12 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 2020; gutjnl-2020- 322026
13 Chan KS, Ho S, Pang K. et al. Comparison of weight loss and improvement in metabolic comorbidities between endoscopic gastroplasty and lifestyle modifications: a meta-analysis. Surg Laparosc Endosc Percutan Tech 2025; 35 (03) e1361
14 Wetterslev J, Thorlund K, Brok J, Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol 2008; 61 (01) 64-75
15 Lopez Nava G, Asokkumar R, Laster J. et al. Primary obesity surgery endoluminal (POSE-2) procedure for treatment of obesity in clinical practice. Endoscopy 2021; 53 (11) 1169-1173
16 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 (01) 81-89.e4
17 Huberty V, Machytka E, Boškoski I, Barea M, Costamagna G, Deviere J. Endoscopic gastric reduction with an endoluminal suturing device: a multicenter prospective trial with 1-year follow-up. Endoscopy 2018; 50 (12) 1156-1162
18 Espinet Coll E, Nebreda Durán J, López-Nava Breviere G. et al. Multicenter study on the safety of bariatric endoscopy. Rev Esp Enferm Dig 2017; 109 (05) 350-357
19 Bhandari M, Kosta S, Reddy M, Mathur W, Neto MG, Bhandari M. Four-year outcomes for endoscopic sleeve gastroplasty from a single centre in India. J Minim Access Surg 2023; 19 (01) 101-106
20 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. Dig Endosc 2020; 32 (04) 541-546

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