How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Other relevant studies

    Other potentially relevant studies to the IP overview that were not included in the main evidence summary (tables 2 and 3) are listed in table 5.

    Table 5 additional studies identified

    Article

    Number of patients and follow up

    Direction of conclusions

    Reason study was not included in main evidence summary

    Alexandrea F, Lapergolaa A, Vannucci M et al. (2023) Endoscopic management of obesity: Impact of endoscopic sleeve gastroplasty on weight loss and co-morbidities at six months and one year. Journal of Visceral Surgery 160, S38—S46.

    Prospective case series.

    N=99 patients had ESG.

    BMI 42.7 ± 7.8 kg/m2

    Follow-up 12 months.

    ESG is a well-tolerated and safe surgical procedure that is effective in terms of weight loss and reduction of obesity-related comorbidities at 6 months and 1 year.

    Higher level evidence included in evidence summary

    Abu Dayyeh BK, Acosta A, Camilleri M, et al. (2017) Endoscopic sleeve gastroplasty alters gastric physiology and induces loss of body weight in obese individuals. Clin Gastroenterol Hepatol; 15: 37–43

    Observational study (prospective)

    N=25 patients with BMI between 30 and 40 kg/m2 had ESG.

    Follow-up 20 months

    ESG delays gastric emptying, induces early satiation, and significantly reduces body weight. ESG could be an alternative to bariatric surgery for selected patients with obesity.

    Included in systematic reviews added to evidence summary.

    Abu Dayyeh B, Rajan E, Gostout CJ. (2017) Gastric endoscopic remodeling techniques. Techniques in Gastrointestinal Endoscopy. 19(1):22-26.

    Descriptive review of the various techniques to remodel the stomach, with an emphasis on safety and efficacy.

    ESG is a well-tolerated outpatient intervention, with most patients returning to a functional status within 24 to 48 hours after the intervention. To date, 2 endoscopic bariatric techniques (ESG and POSE) seem to be safe, reproducible, cost effective and produce 25% excess weight loss at 1 year.

    Review

    Alqahtani A, Al-Darwish A, Mahmoud AE, et al. (2019) Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients. Gastrointest Endosc; 89(6):1132–8.

    Observational study (prospective).

    N=1,000 patients with BMI > 40 kg/m2 or 35 kg/m2 with comorbidities had ESG.

    Follow-up 18 months

    ESG appears to be well tolerated, safe, and effective. Significant weight loss occurs during the first 18 months without mortality or significant morbidity. Some patients need revision or reversal during the first year.

    Included in systematic reviews added to evidence summary.

    Alqahtani AR, Elahmedi M, Aldarwish A et al. (2022) Endoscopic Gastroplasty Versus Laparoscopic Sleeve Gastrectomy: A Non-Inferioirty Propensity Score Matched Comparative Study. Gastrointest Endosc (2022) doi:10.1016/j.gie.2022.02.050

    Propensity score matched study of patients who underwent ESG or LSG.

    3,180 pairs.

    Average 33.3 kg/m2.

    Follow-up 36 months.

    Mean %EWL at 1, 2, and 3 years after ESG was 77%, 75% and 60% respectively. Mean %EWL at 1, 2, and 3 years after LSG was 95%, 94%, and 74% respectively. The mean difference in %TWL was 9.7% (p<0.001), 6.0% (p<0.001), and 4.8% (p<0.001) at 1, 2, and 3 years, respectively. 14 ESG patients developed adverse events (0.5%) versus 10 LSG patients (0.3%). Comorbidity remission rates after ESG versus LSG were 64% versus 82% for diabetes, 66% versus 64% for dyslipidaemia, and 51% versus 46% for hypertension, respectively. 80 ESG patients (3%) had revision to LSG for insufficient weight loss or weight regain, and 28 had resuturing after primary ESG (1%).

    Study included in a meta-analysis added to evidence summary.

    Asokkumar R, Hong Lim C, Tan AS et al. (2021) Safety and early efficacy of endoscopic sleeve gastroplasty (ESG) for obesity in a multi-ethnic Asian population in Singapore. Journal of gastroenterology and hepatology 5, 1351–1356

    Retrospective case series.

    N=35 patients who had primary ESG for obesity. Mean BMI 34 kg/m2.

    Chinese ethnicity 51%.

    Follow-up 6 months.

    21 patients completed 3 months of follow-up, and 10 patients 6 months. The mean TBWL at 3 and 6 months were 15% and 16%, respectively. Improvement in diabetes mellitus (87%), fatty liver (86%), and hypertension (58%) was also reported.

    Larger and more comprehensive studies included in evidence summary.

    Lavín-Alconero L, Fernández-Lanas T, Iruzubieta-Coz P et al. (2021) Efficacy and safety of endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy in obese subjects with NonAlcoholic SteatoHepatitis (NASH): study protocol for a randomized controlled trial (TESLA-NASH study). Trials; 22:756.

    RCT protocol.

    N=30 patients with obesity with or without metabolic syndrome and NASH.

    endoscopic sleeve gastroplasty (ESG) versus laparoscopic sleeve gastrectomy (LSG).

    This clinical trial will help us apply different tactics to the treatment of obesity and NASH.

    Protocol only

    Badurdeen D, Farha J, Fayad L et al. (2022) The Attitude of Practitioners Towards Endoscopic Sleeve Gastroplasty . J Clin Gastroenterol;56:756–763.

    Survey of 1,200 bariatric endoscopists trained to perform endoscopic suturing using the Apollo OverStitch suturing device.

    ESG practice trends remain heterogenous among practitioners in regard to indication, technique, and preprocedural and postprocedural management. Specific ESG guidelines are warranted.

    Survey on clinical practice.

    Barrichello S, Hourneaux de Moura DT, Hourneaux de Moura EG, et al. (2019) Endoscopic sleeve gastroplasty in the management of overweight and obesity: an international multicenter study. Gastrointest Endosc. 90 (5), 770-780.

    Observational study (prospective).

    N=193 overweight or obese patients who failed diet and lifestyle modifications and had ESG.

    Follow-up 12 months.

    All groups had more than 10% TWL and more than 25% EWL at 6 months. On average, %TWL was 14% and 15%, and the %EWL 56% and 59%, at 6 months and 1 year. ESG appears to be feasible, safe, and effective in the treatment of patients with overweight and obesity according to ASGE/ASMBS thresholds.

    Included in systematic reviews added to evidence summary.

    Bhandari M, Jain S, Mathur W, Kosta S, Neto MG, Brunaldi VO, et al. (2020)Endoscopic sleeve gastroplasty is an effective and safe minimally invasive approach for treatment of obesity: first Indian experience. Dig Endosc; 32 (4), 541-546.

    Observational retrospective study.

    N=53 patients with mean BMI 34.8 kg/m2 had ESG.

    Follow-up 12 months.

    Average %TWL was 8%, 12%, 14%, and 20% at 1, 3, 6, and 12 months, respectively. 88% of patients achieved more than 15% TWL at 12 months. Younger and female patients had greater %TWL.

    Included in systematic reviews added to evidence summary.

    Balint IB, Csordas J, and Csaszar F. (2023) Is endoscopic approach superior to laparoscopic surgery for gastric plication in terms of complications and efficacy? A systematic review including meta-analysis. Minerva Surgery, 78, 1-10.

    Systematic review and meta-analysis.

    18 endoscopic bariatric metabolic therapies (EBMT) studies (2 techniques 14 ESG studies and 4 POSE studies are assessed, n=3585)

    LGCP 29 studies, N=2350

    6 months to 5 years follow-up.

    EBMTs appeared to be superior to LGCP regarding safety but differences did not reach statistical threshold. Weight loss outcomes were favourable after each method. EBMTs imitating LGCP are promising safe and effective methods.

    Results not analysed separately for different EBMTs.

    Boškoski I, Pontecorvi V, Gallo C et al. (2020). Redo endoscopic sleeve gastroplasty: technical aspects and short-term outcomes. Ther Adv Gastroenter. 13,1-6.

    Retrospective analysis of prospective data.

    N=120 patients who underwent ESG

    at 12 months mean %EWL was 44%, mean %TBWL was 18%.

    4 patients had ESG revisions within 12 months. No adverse events were reported during redo-ESG. 6 month follow-up for 3 patients reported that mean %EWL and %TBWL were 44% and 20%.

    Not primary ESG. Revisions of ESG.

    Higher level evidence included in evidence summary.

    Carr P, Keighley T, Petocz P, et al. (2022) Efficacy and safety of endoscopic sleeve gastroplasty and laparoscopic sleeve gastrectomy with 12+ months of adjuvant multidisciplinary support. Bmc Prim Care. 23(1):26.

    Prospective study (2 arm).

    N=61 patients with obesity who received ESG or LSG with 12+ months of adjuvant multidisciplinary pre‑ and postprocedural support.

    N=16 ESG (BMI 35.5 kg/m2)

    N=45 LSG (BMI 40.5 kg/m2)

    Follow up 12 months.

    ESG and LSG were safe and effective weight loss treatments for obese adults along‑ side multidisciplinary support. Patients who elected the ESG maintained fat-free mass at 6-months but both cohorts lost fat-free mass at 12-months post procedure. Patients who elected the LSG had large and significant improvements to weight-related quality of life. Further well-powered studies are required to confirm these findings.

    Large studies included in evidence summary.

    Cheskin LJ, Hill C, Adam A et al. (2020) Endoscopic sleeve gastroplasty versus high-intensity diet and lifestyle therapy: a case-matched study. Gastrointest Endosc; 91: 342–349.e1

    Observational case-matched study.

    Patients with mean BMI 40 kg/m2

    105 ESG and high-intensity diet and lifestyle therapy (HIDLT) versus 281 patients with HIDLT alone.

    Follow-up 12 months

    Mean %TBWL at 1, 3, 6, and 12 months was significantly higher in patients undergoing ESG than patients undergoing HIDLT. Specifically, at 3 months, the mean %TBWL in the ESG cohort was 14% compared with 11% in the HIDLT cohort (p<0.011) and at 12 months the mean %TBWL in the ESG cohort was 21% versus 14% in the HIDLT cohort (p<0.001).

    Included in systematic reviews added to evidence summary

    Cohen RV, Oliveira da Costa MV, Charry L et al. (2019) Endoscopic gastroplasty to treat medically uncontrolled obesity needs more quality data: A systematic review. Surg Obes Relat Dis. 1-6.

    Systematic review (included both ESG and POSE endoscopic gastroplasty (EG) technique - plication of the fundus).

    (2 RCTs on POSE,14 observational studies, 9 case reports were included).

    The case series reported 16% to 19% total weight loss, but few had more than 6 months of follow-up. Serious adverse events ranged from 2% to 10%. Review concluded that endoscopic gastroplasty does not have enough quality scientific evidence regarding long-term weight loss and the procedure's safety to recommend the use in current clinical practice.

    More recent comprehensive studies included in the evidence summary.

    Review combined ESG with other endoscopic gastroplasty techniques, including plication of the fundus, that uses different devices and mechanism of action.

    Currie AC, Galysher MA, Blencowe NS et al. (2021) Systematic Review of Innovation Reporting in Endoscopic Sleeve Gastroplasty. Obesity Surgery. 31:2962–2978

    Systematic review.

    16 retrospective cohort studies, 17 prospective cohort studies and 3 case reports included.

    The number of patients in the included studies ranged from 1 to 1000. The lower BMI limit ranged from 27 to 35 kg/m2. Research approvals were reported in 26 studies. Two studies reported on the learning curve. All studies reported some aspect of technical implementation, but many variations were noted. Suturing device used and suture pattern were the most commonly reported aspects (32 studies). Follow-up ranged from 1 to 24 months but was 12 months or less in 28 studies. 48 different outcomes were reported across all studies.

    Recent meta-analyses included in the evidence summary.

    Dayyeh BKA, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013;78(3):530-535

    Prospective case series.

    N=4 patients with BMI between 30-40 kg/m2 had ESG.

    Early results are encouraging and suggest that endoscopy-based intraluminal therapies may provide the next major treatment advance in this area.

    Larger studies included in evidence summary.

    de Souza TF, Neto ACM, Coronel MA et al. The First Study Evaluating Effectiveness and Safety of the Endoscopic Sleeve Gastroplasty in HIV Patients. Obesity Surgery (2020) 30:1159–1162.

    Retrospective case series.

    N=7 patients with HIV had ESG

    Mean BMI 33.7 kg/m2

    After 6 months, absolute weight loss, percentage of excess weight loss, percentage total weight loss, and BMI reduction were 20.2 kg, 86%, 21%, and 7.1 kg/m2, respectively. No patients presented severe adverse events.

    Larger studies included in evidence summary.

    Espinet-Coll E, Nebreda-Durán J, Galvao-Neto M, et al. (2020) Suture pattern does not influence outcomes of endoscopic sleeve gastroplasty in obese patients. Endosc Int Open.08(10):E1349-E1358

    Retrospective review of prospective data.

    N=88 patients who had ESG (with 3 different suture patterns - transverse bilinear, longitudinal and transverse monolinear and number of sutures (4 to 7) and stitches (less than 25, 25 to 30 and more than 30) were compared.

    ESG is an effective procedure at 12-month follow-up for weight loss and comorbidity resolution. All 3 analysed patterns are safe and effective without differences in %TBWL, but there was a slight increase in %EWL in longitudinal pattern, regardless of the number of sutures or stitches applied.

    Higher level evidence included in evidence summary.

    Espinet Coll E, Vila Lolo C, Díaz Galán P, et al. Bariatric and metabolic endoscopy in the handling of fatty liver disease. A new emerging approach? Rev Esp Enferm Dig NLM. 2019;111:283–93.

    Observational prospective study.

    N=15 patients with mean BMI 38.82 kg/m2 and non-alcoholic fatty liver disease had ESG.

    Follow-up 12 months.

    Bariatric endoscopy could be proposed during short-term follow-up as an effective and safe alternative in patients with obesity and NAFLD.

    Included in systematic reviews added to evidence summary.

    Espinet-Coll, E. et al. Persistence of Sutures and Gastric Reduction After Endoscopic Sleeve Gastroplasty: Radiological and Endoscopic Assessment. Obes Surg 1–11 (2022)

    Prospective study.

    N=38 patients with obesity (BMI 37.6 kg/m2) had ESG.

    Follow-up 1 year.

    Median %TWL of 17% with TWL more than 10% in 95% of patients was obtained at 1 year. No major AEs were observed. ESG is an effective and safe weight loss strategy at 12-month follow-up with persistence of most sutures and maintenance of notable gastric reduction and remodelling.

    High strength evidence included in the evidence summary.

    Farha J, McGowan C, Hedjoudje A, et al. (2020) Endoscopic sleeve gastroplasty: suturing the gastric fundus does not confer benefit. Endoscopy. 53(07):727-731.

    Retrospective analysis.

    N=247 patients

    ESG with fundal suturing versus no fundal suturing (ESG-NFS)

    Follow-up 12 months.

    %EWL at 3 months ESG-NFS: 38%; ESG-FS: 1%. %EWL was significantly greater in the ESG-NFS group at both at 6 months and 12 months compared with the ESG-FS group (p<0.001). SAEs (perigastric abscess, gastric perforation and bleeding) occurred in 2% of patients. Sparing the fundus results in superior mean %EWL at 3, 6, and 12 months. Both cohorts achieved a %EWL that exceeded the recommended level of 25%.

    Higher level evidence included in the evidence summary.

    Fiorillo C, Quero G, Vix M, et al. 6-Month Gastrointestinal Quality of Life (QoL) Results after Endoscopic Sleeve Gastroplasty and Laparoscopic Sleeve Gastrectomy: A Propensity Score Analysis. Obes Surg. 2020;30(5):1944-1951.

    Retrospective analysis. Propensity scored matched analysis.

    N=183

    ESG versus LSG

    23 matched pairs

    LSG may significantly affect QoL and results in worsening of gastrointestinal symptoms including GERD. ESG is a promising less invasive bariatric endoscopic procedure that demonstrated a positive impact on both QoL and comorbidities, which could lead to greater patient acceptance earlier in their disease or at a younger age.

    Study included in systematic review and meta-analyses added to evidence summary.

    Fayad L, Adam A, Schweitzer M, et al. (2019) Endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy: a case-matched study. Gastrointest Endosc. 89(4):782-788.

    Retrospective review of prospective data -case-matched study.

    N=138 patients who underwent ESG (n=54) or LSG (n=83)

    At the 6-month follow-up, %TBWL (compared with baseline) was significantly lower in the ESG group compared with the LSG group (17% versus 24%, p<0.01). ESG patients had significantly lower rates of adverse events compared with LSG patients (5% versus 17%, p<0.05). New-onset GERD was also significantly lower in the ESG group compared with the LSG group (2% versus 15%, p<0.05).

    Study included in systematic review and meta-analyses added to evidence summary.

    Glaysher M, Moekotte A, Kelly J. (2019) Endoscopic sleeve gastroplasty: a modified technique with greater curvature compression sutures. Endosc Int Open. 07(10):E1303-E1309.

    Retrospective review.

    N=32 patients (BMI 36.5 kg/m2) who had ESG (sutures with longitudinal compression pattern and no pattern).

    The technique of ESG is evolving and outcomes continue to improve. Preliminary evidence of superior weight loss achieved through a modified gastroplasty suture pattern.

    Higher level evidence included in evidence summary.

    Goyal H, Kopel J, Perisetti A et al. (2021) Endobariatric procedures for obesity: clinical indications and available options. Ther Adv Gastrointest Endosc, Vol. 14: 1–17.

    Review

    Review elaborates on the clinical indications and efficacy of the Endo bariatric procedures, together with various types of available endoscopic bariatric therapy procedures.

    General review

    Gudur AR, Geng C, Hallowell P et al. (2022) Impact of Proceduralist Specialty on Outcomes Following Endoscopic Sleeve Gastroplasty. Obesity Surgery. 32:3714–3721.

    Retrospective analysis of 6,000 patients who underwent ESG.

    No difference in adverse events in ESG performed by gastroenterologists and bariatric surgeons. ESG performed by bariatric surgeons demonstrated a trend towards higher rate of re-operations within 30 days. ESG performed by gastroenterologists had more ED visits but did not lead to higher rate of re-intervention. Length of stay was shorter in ESG performed by gastroenterologists, but procedure time was longer.

    Studies with clinical outcomes included in evidence summary.

    Gys B, Paleke P, Lamme B et al. (2019) Endoscopic Gastric Plication for Morbid Obesity: a Systematic Review and Meta-analysis of Published Data over Time. Obesity Surgery, 29:3021–3029.

    22 cohort studies on 7 different devices, with 2,475 patients were included. BMI 37.8 ± 4.1 kg/m2.

    Either a transoral endoluminal stapling or (suction based) (full thickness) stitching and/or anchor device was used to obtain gastric volume reduction and/or alter gastric outlet.

    Mean follow-up was 13 months (median 12; range 6–24)

    Endoscopic sleeve gastroplasty (ESG) and the primary obesity surgery endolumenal (POSE). Average pooled %EWL at 6 months (p=0.02) and 12 months (p=0.04) in favour of ESG was 57.9% (50.5 to 65.5, I2=0%), 44.4% (40.2 to 48.5, I2=0%), and 68.3% (60.9 to 75.7, I2=5.8%), 44.9% (40.9 to 49.0) for ESG and POSE respectively. Major adverse events without mortality were described in 25 patients (9 studies, p=0.63).

    Devices included in this review vary in technique and have their own specific features. Evidence on ESG already covered in other studies added to table 2.

    Hajifathalian K, Mehta A, Ang B, et al. (2021) Improvement in insulin resistance and estimated hepatic steatosis and fibrosis after endoscopic sleeve gastroplasty. Gastrointest Endosc. 93(5):1110-1118.

    Prospective study.

    N=118 patients with obesity (mean BMI 40.7 kg/m2) and non-alcoholic fatty liver disease (NAFLD) underwent ESG.

    Follow-up 2 years

    Results suggest a significant and sustained improvement in estimated hepatic steatosis and fibrosis after ESG in patients with NAFLD. Importantly, showed an early and weight-independent improvement in insulin resistance, which lasted for 2 years after the procedure.

    Studies reporting weight loss as primary outcome were included in the evidence summary.

    Hedjoudje A, Abu Dayyeh BK, Cheskin JL et al. (2020) Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis. Clinical Gastroenterology and Hepatology

    18, 5, 1043-1053.

    Systematic review and meta-analysis.

    N=1,772 patients from 8 studies

    Study reported 6-month mean %TBWL of 15.1%, mean percentage of excess body weight loss (%EBWL) of 58%, and mean reduction in body mass index (BMI) of 5.7 kg/m2. Weight loss was sustained at 12 and 18 to 24 months with a TBWL of 17%. Rate of severe adverse events was 2% including pain or nausea requiring hospitalisation (n=18, 1%), upper gastrointestinal bleeding (n=9, 0.6%), and peri-gastric leak or fluid collection (n=8, 0.5%).

    More recent and comprehensive study included in evidence summary.

    Jain D, Bhandari BS, Arora A, Singhal S. Endoscopic sleeve gastroplasty—a new tool to manage obesity. Clin Endosc 2017;50:552–6

    Review of 9 studies (n=172 patients) on ESG. Only 51 patients had 6 months follow-up.

    Technical success rate for intact gastric sleeve was 50% to 100%. A statistically significant weight loss was reported in 7/8 studies. No mortality but 2% (4/172) of patients experienced major post-procedure complications.

    More comprehensive systematic reviews included in evidence summary.

    James TW, Reddy S, Vulpis T et al. (2020). Endoscopic Sleeve Gastroplasty Is Feasible, Safe, and Effective in a Non-academic Setting: Short-Term Outcomes from a Community Gastroenterology Practice. Obes Surg. 30(4):1404-1409.

    Retrospective review.

    N=100 patients who had ESG.

    Mean 12-month TBWL was 29.8 kg (23%), with excess weight loss of 66%. Over this time period, mean change in BMI was 9.43 kg/m2.

    Higher strength studies included in evidence summary.

    Jagtap N, Kalapala R, Katakwar A, et al. Endoscopic sleeve gastroplasty — minimally invasive treatment for non-alcoholic fatty liver disease and obesity. Indian J Gastroenterology. 2021;40(6):572-579.

    Prospective study.

    N=26 patients with obesity (mean weight 99 kg/m2) and NAFLD who had ESG.

    Follow-up 12 months.

    ESG is a safe and effective treatment option for patients with NAFLD and obesity causing significant total body weight loss (18%) at 12 months, with significant improvement in HbA1c. No serious major events reported. Rigorous randomized trials are required to incorporate ESG in NAFLD treatment algorithm.

    High strength studies included in evidence summary.

    Jalal MA, Cheng Q, Edye MB et al. (2020) Systematic Review and Meta-Analysis of Endoscopic Sleeve Gastroplasty with Comparison to Laparoscopic Sleeve Gastrectomy. Obesity Surgery, 30:2754–2762.

    Systematic review and meta-analysis.

    5 studies (3 ESG cohort studies and 2 case-matched cohort studies comparing ESG with LSG). ESG and LSG patients were 1,451 and 203.

    Short-term total body weight loss (TBWL%) at 6 months ranging from 14 to 15% for ESG reported. 2 LSG papers demonstrated a superior TBWL% of 24% at 6 months, with 1 paper reporting a 12-month TBWL% of 29%. 2 ESG papers reported medium-term results at 18 months and 24 months of 15% and 19%, respectively. ESG had a complication rate between 2 and 3%, while LSG had a complication rate between 9 and 17%. In both procedures, there were no grade 4 or 5 complications.

    More recent meta-analysis included in evidence summary.

    Khan Z, Khan MA, Hajifathalian K, et al. Efficacy of Endoscopic Interventions for the Management of Obesity: a Meta-analysis to Compare Endoscopic Sleeve Gastroplasty, AspireAssist, and Primary Obesity Surgery Endolumenal. Obes Surg. 2019;29:2287–98.

    Systematic review and meta-analysis

    included ESG, AspireAssist, and primary obesity surgery endolumenal (POSE). 12 studies with 1,149 patients were included.

    During a follow-up of 6 to 12 months, both AspireAssist and ESG had excellent efficacy in achieving significant and sustained weight loss; however, ESG was found to be superior in terms of weight loss when compared with POSE.

    3 different endoscopy procedures assessed here and Aspire Assist is different to the other 2 plication procedures used. So recent comprehensive reviews on ESG included in evidence summary.

    Kozłowska‑Petriczko K, Pawlak KM, Wojciechowska K et al. (2023) The efficacy Comparison of Endoscopic Bariatric Therapies: 6‑Month Versus 12‑Month Intragastric Balloon Versus Endoscopic Sleeve Gastroplasty. Obesity Surgery, 33:498–505.

    Retrospective analysis.

    IGB (Orbera) removal after 6 months (124 patients), at IGB (Orbera365) removal after 12 months (61 patients) and at 6 months and 12 months after ESG (42 and 34 patients, respectively).

    All 3 studied methods were effective for achieving weight loss. However, there was no significant difference between 6-month and 12-month IGB therapies outcomes. ESG appeared to be a more effective obesity treatment modality than IGB.

    Similar comparative studies included in a systematic review added to evidence summary.

    Kumar N, Abu Dayyeh BK, Lopez-Nava Breviere G, et al. (2018) Endoscopic sutured gastroplasty: procedure evolution from first in-man cases through current technique. Surg Endosc. 32: 2159–64

    Observational prospective study.

    N=99 patients

    Phase 2- mean BMI 34.3 kg/m2 (n=22)

    Phase 3-mean BMI 36.1 kg/m2 (n=77)

    Follow-up 6-12 months.

    Phase 2- 1-year total weight loss was 17% (n=22)

    Phase 3- mean weight loss was 16% at 6 months and 17% at 12 months (n=44). No significant adverse events reported.

    Included in systematic reviews added to evidence summary.

    Lopez-Nava G, Negi A, Bautista-Castaño I, et al. (2020) Gut and Metabolic Hormones Changes After Endoscopic Sleeve Gastroplasty (ESG) Vs. Laparoscopic Sleeve Gastrectomy (LSG). Obes Surg. 30(7):2642-2651.

    Prospective study.

    N=24 patients

    12 ESG compared with 12 LSG

    Follow-up 6 months

    ESG induced gut hormone changes differently as compared to LSG. ESG prevented a compensatory rise in ghrelin and promoted beneficial changes in the insulin secretory pattern with weight loss.

    Primary outcome not weight loss.

    Lopeznava G, Asokkumar R, Bautista I, et al. (2020) Endoscopic sleeve gastroplasty, laparoscopic sleeve gastrectomy, and laparoscopic greater curve plication: do they differ at 2 years? Endoscopy. 53(03):235-243

    Retrospective review.

    N=296 patients who had (ESG 135, LSG 43, LGCP 32).

    Follow-up 2 years.

    ESG had a significantly lower TBWL, %TBWL, and BMI decline compared with LSG and LGCP at all time points (p=0.001). The adjusted mean %TBWL at 2 years for ESG, LSG, and LGCP were 19%, 28%, and 27%, respectively.

    Included in systematic reviews added to evidence summary.

    Lopeznava G, Asokkumar R, Negi A et al. (2021) Resuturing After Primary Endoscopic Sleeve Gastroplasty For Obesity. Surgical Endoscopy. 35:2523–2530

    Retrospective analysis.

    N=of 482 patients with primary ESG 7% (32) had red o ESG – 12 for weight loss failure, 12 for weight regain, and 11 for weight plateau.

    The need for redo-ESG after primary ESG is low. redo-ESG is safe and induced weight loss in all patients. The maximum benefit was observed in patients who lost 10% or more TBWL but could not lose further over 3 months. No serious complications occurred.

    Not primary ESG. Revisions of ESG.

    Higher level evidence included in evidence summary.

    Lopeznava G, Lster J, Negi A et al. (2022) Endoscopic sleeve gastroplasty (ESG) for morbid obesity: how effective is it? Surgical Endoscopy. 36:352–360.

    Retrospective review.

    N=435 patients (class 1 33 kg/m2: 105, class 2 37.5 kg/m2: 169, class 3 44.5 kg/m2: 161) who had ESG.

    Follow-up 12 months.

    ESG had a significantly higher TBWL, %TBWL, and BMI decline in class 3 compared to classes 1 and 2 obesity at all time points (p<0.001). The adjusted mean %TBWL at 1 year with classes 1, 2, and 3 obesity was 17%, 18%, and 21%, respectively. The overall complication rate and the hospital stay was identical in the 3 groups.

    Higher level evidence included in evidence summary.

    Lopez-Nava G, Sharaiha RZ, Vargas EJ, et al. (2017) Endoscopic Sleeve Gastroplasty for Obesity: a Multicenter Study of 248 Patients with 24 Months Follow-Up. OBES SURG. 27(10):2649-2655.

    Retrospective review.

    N=248 patients who had ESG.

    BMI 37.8 kg/m2

    Follow-up 24 months.

    At 6 and 24 months, %TBWL was 15 and 19 respectively. At 24 months, the proportion of patients achieving 10% or more TBWL was 84 and 53%, respectively.

    Study included in systematic reviews added in evidence summary.

    Lopez-Nava G, Galvão MP, Bautista-Castaño I, et al. (2017) Endoscopic sleeve gastroplasty for obesity treatment: two years of experience. Arq Bras Cir Dig. 30:18–20.

    Observational prospective study.

    N=154 patients with BMI 38.3 kg/m2 had ESG.

    Follow-up 24 months.

    Baseline mean BMI change from 38.3 to 30.8 kg/m2 at 24 months. TBWL, %TBWL and %EWL were of 21.3 kg, 19.5% and 60.4% respectively. 86% of patients achieved the goal of more than 25% %EWL. There were no major adverse events.

    Included in systematic reviews added to evidence summary.

    Lopez-Nava G, Asokkumar R, Rull A et al. (2019) Bariatric endoscopy procedure type or follow-up: What predicted success at 1 year in 962 obese patients? Endosc Int Open. 07(12):E1691-E1698.

    Retrospective review of prospective data.

    N=962 patients had either endoscopic gastroplasty (n=481) and intragastric balloons (n=481)

    Only 480 patients (IGB 45 %; ESG-55 %) completed 1 year follow-up. Among them, Apollo ESG achieved significantly higher TBWL (19.5 %, p=0.035), %TBWL (17.4 %, p=0.025), and   20 % or more TBWL (36.7 %, p= 0.032).

    Higher strength evidence included in evidence summary.

    Lopez-Nava G, Galvão MP, Bautista-Castaño I, Jimenez-Baños A, Fernandez-Corbelle JP. Endoscopic Sleeve Gastroplasty: How I Do It? OBES SURG. 2015;25(8):1534-1538.

    Prospective study.

    N=50 patients (average BMI 37.7 kg/m2) who had ESG

    Follow up 12 months.

    There were no major intra-procedural, early, or delayed adverse events. Weight loss parameters were satisfactory, mean BMI changes from 37.7 to 30.9 kg/m2 at 1 year and mean %TBWL was 19.0.

    Larger studies included in evidence summary.

    Lopez-Nava G, Galvo M, Bautista-Castaño I et al. Factors predictive of success with endoscopic sleeve gastroplasty… Endoscopy International Open 2016; 04: E222–E227

    Prospective study.

    N=25 patients with mean BMI 38.5 kg/m2 had ESG.

    Follow-up 1 year

    Endoscopic sleeve gastroplasty is a feasible, reproducible, and effective procedure to treat obesity. Nutritional and psychological interaction are predictive of success.

    Larger studies included in evidence summary.

    Li P, Ma B, Gong S, et al. (2019) Efficacy and safety of endoscopic sleeve gastroplasty for obesity patients: a meta-analysis. Surg Endosc; 34:1253–1260.

    Systematic review and meta-analysis. ESG in 1,.542 patients from 9 studies.

    The pooled results of %TBWL at 1, 3, 6, and 12 months were 8.8% (p=0.000), 11.9% (p=0.000), 14.5% (p=0.024), and 16.1% (p=0.063), respectively. The pooled results of %EWL at 1, 3, 6, and 12 months were 31.2% (p=0.000), 43.6% (p=0.000), 53.1% (p=0.000), and 59.1% (p=0.015), respectively. The pooled rate of mild adverse events was 72% (p<0.01) and severe adverse events was 1% (p=0.08).

    More recent comprehensive studies included in the evidence summary.

    Li R, Veltzke-Schlieker W, Adler A, et al. (2021) Endoscopic Sleeve Gastroplasty (ESG) for High-Risk Patients, High Body Mass Index (> 50 kg/m2) Patients, and Contraindication to Abdominal Surgery. Obes Surg. 31:3400–3409.

    Prospective study.

    N=24 patients with high-risk, high BMI (49.9 kg/m2) and those contraindicated to abdominal surgeries.

    Follow-up 12 months.

    Weight loss, BMI reduction, %TWL, and %EWL were 17.5 kg, 5.6 kg/m2, 12.2%, and 29.1% at post-ESG 12-month, respectively. One (4%) moderate post-procedure adverse event (gastric mucosal bleeding) was observed.

    Larger studies included in table 2.

    Morales JG, Crespo LC, Marques A, et al. (2018) Modified endoscopic gastroplasty for the treatment of obesity. Surg Endo sc.32:3936–42.

    Observational study, retrospective.

    N=148 patients with average BMI 35 kg/m2 has ESG with a Z suture pattern.

    Follow-up 18 months.

    TWL was 17.5 kg in 12 months and 18.5 kg in 18 months. Patients with a BMI less than 35 kg/m2 benefited most. One case of mild bleeding reported.

    Included in systematic reviews added to evidence summary.

    Mohan BP, Asokkumar R, Khan SR et al. (2020) Outcomes of endoscopic sleeve gastroplasty; how does it compare to laparoscopic sleeve gastrectomy? A systematic review and meta-analysis. Endoscopy International Open; 08: E558–E565.

    Systematic review and meta-analysis.

    3,994 patients from 15 studies. 8 ESG studies (1,815 patients) and 7 LSG studies (2,179 patients).

    In ESG the pooled rates of %TWL at 1 month, 6 months, and 12 months were 8.7, 15.3 and 17.1, respectively. The pooled rates of %EWL at 1 month, 6 months, and 12 months were 31.7, 59.4 and 63 respectively. The pooled rates of BMI at 1 month, 6 month, and 12 months were 32.6, 30.4 and 30 respectively. At 12 months, the pooled %TWL, %EWL and BMI with LSG (7 studies, 2,179 patients) were 30.5 69.3 and 29.3 respectively. %TWL with LSG was superior to ESG (p=0.001). %EWL and BMI were comparable. All adverse events, were significantly lower with ESG when compared to LSG.

    Similar analysis included in evidence summary.

    Manos T, Noel P, Bastid C et al. Endoscopic Gastroplasty. Initial Experience. Chirurgia (2019) 114 (6): 747-752.

    Prospective study.

    N=17 patients had ESG. Group A (with BMI less than 35 and primary obesity – 10 patients) and Group B (with BMI more than 35, or previous gastric balloon or bariatric surgery – 7 cases).

    Endoscopic gastroplasty represent a safe minimal invasive approach that can be considered as an effective and well tolerated procedure especially for primary obesity treatment. For patients with previous bariatric surgical procedures or with severe obesity the results are less favourable.

    Larger studies included in table 2.

    Manos T, Costil V, Karsenty L et al. Safety of Endoscopic Sleeve Gastroplasty with a Single‑Channel Endoscope. Obesity Surgery (2022) 32:3074–3078.

    Retrospective study

    N=191 had ESG using the new suturing device OverStitch Sx™

    Endoscopic gastroplasty represents a safe minimal invasive approach with the new device OverStitch Sx™. 2 postprocedural complications (1%), a transparietal suturing of falciform ligament which needed laparoscopic exploration for severe abdominal pain and a perigastric collection with antibiotic treatment, both with favourable outcome. 12 patients underwent revisional bariatric procedure.

    Safety outcomes already reported in studies included in the evidence summary.

    Matteo MV, Bove V, ·Pontecorvi V et al. Outcomes of Endoscopic Sleeve Gastroplasty in the Elder Population. Obesity Surgery (2022) 32:3390–3397.

    Retrospective analysis.

    N=18 patients (BMI was 41.2 kg/m2) aged 65 years and older had ESG.

    The median TBWL% was 15%, 16%, and 16% at 6, 12, and 24 months, while the median %EWL was 39%, 37%, and 41% at 6, 12, and 24 months. ESG is a promising therapeutic option for elder individuals with obesity who fail non-invasive methods, and who refuse or are deemed not suitable for bariatric surgery because of age and comorbidities.

    Larger studies included in evidence summary.

    Maydeo A, Patil G, Dalal A et al. (2020) An Indian Experience of Endoscopic Treatment of Obesity by Using a Novel Technique of Endoscopic Sleeve Gastroplasty (Accordion Procedure). Journal of The Association of Physicians of India. 68,

    Prospective study. n=58 patients who had ESG.

    The mean weight reduced significantly from baseline of 98.3 to 81.8 kg at 6 months (p<0.001). mean BMI reduced from 37.8 to 31.3 kg/m2 at 6 months (p<0.001). The mean % of TWL was 8.8, 12.6 and 17.1 at 1, 3 and 6 months respectively. The % of EWL was 21.3, 30.5 and 42.8 at 1, 3 and 6 months respectively. No major complications reported.

    Larger studies included in evidence summary.

    Moura D de, Jr SB, Moura E de, et al. Endoscopic sleeve gastroplasty in the management of weight regain after sleeve gastrectomy. Endoscopy. 2020;52(03):202-210

    Retrospective study.

    N=34 patients with weight regain following sleeve gastrectomy who underwent ESG.

    ESG appears to be safe and effective in the management of weight regain following sleeve gastrectomy.

    Not primary ESG.

    Novikov AA, Afaneh C, Saumoy M, et al. (2018) Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare? J Gastrointest Surg. 22(2):267-273.

    Retrospective study.

    N=278 obese (BMI more than 30) patients (n=278) who underwent ESG (n=91, overStitch), LSG (n=120), or LAGB (n=67, lap-band system).

    12 months follow-up.

    At 12-month follow-up, LSG achieved the greatest %TBWL compared to LAGB and ESG (29.3 vs 13.3 vs 17.6%, respectively; p<0.001). However, ESG had a significantly lower rate of morbidity when compared to LSG or LAGB (p=0.01). The LOS was significantly less for ESG compared to LSG or LAGB (0.34 vs 3.09 vs 1.66 days, respectively; p<0.01). Readmission rates were not significantly different between the groups (p=0.72).

    Study included in systematic review and meta-analyses included in the summary of evidence.

    Neto MG, Moon RC, de Quadros LG, et al. (2020) Safety and short-term effectiveness of endoscopic sleeve gastroplasty using overstitch: preliminary report from a multicenter study. Surg Endosc. 34:4388–4394.

    Observational prospective study.

    N=233 patients with mean 34.7 kg/m2 had ESG.

    Follow-up 12 months.

    Mean %TWL was 17.1% at 6 months and 19.7% at 12 months. Percentage of excess BMI loss was 47.3% at 6 months and 54.8% at 12 months. The mean EBMIL was significantly greater among patients with class 1 obesity than those with class 2 obesity at 6 (51.1% vs. 43.7%) and 12 months (60.2% vs. 49.2%). One patient experienced bleeding and was treated with sclerotherapy.

    Included in systematic reviews added to evidence summary.

    Neto MG, Learning Process Effectiveness During the COVID‑19 Pandemic: Teleproctoring Advanced Endoscopic Skills by Training Endoscopists in Endoscopic Sleeve Gastroplasty Procedure. Obesity Surgery (2021) 31:5486–5493.

    Retrospective study

    N=10 patients had ESG guided by a proctor expert using an online platform.

    The proposed teleproctoring program was effective to deliver advanced endoscopic skills such as endosuturing for ESG, despite the restrictions imposed by the COVID-19 pandemic.

    Learning program.

    Neto ACM, Bernardo WM, de Moura DTH et al. (2018) The Effectiveness of Endoscopic Gastroplasty for Obesity Treatment According to FDA Thresholds: Systematic Review and Meta-Analysis Based on Randomized Controlled Trials. Obesity Surgery, 28:2932–2940.

    Systematic review and meta-analysis of RCTs of endoscopic gastroplasty techniques (POSE, TOGA) versus conservative treatment (sham or diet/exercise).

    3 RCTs were included in the meta-analysis n=459 patients (312 EBTs vs 147 control). Mean total body weight loss in the intervention group was 4.8% higher than the control group at 12 months (p=0.01). The intervention group responder rate was 44.3% at 12 months. Therefore, the endoscopic gastroplasty is more effective than conservative therapies but do not achieve FDA thresholds.

    Review grouped 2 procedures with different devices accessories (for suture and plication) and does not include studies on ESG as there were no RCTs. The rationale of both devices is the same: the apposition of the total thickness of tissue to reduce gastric volume.

    Due-Petersson, R., Poulsen, I. M., Hedbäck, N., & Karstensen, J. G. (2020). Effect and safety of endoscopic sleeve gastroplasty for treating obesity – a systematic review. Danish Medical Journal, 67(11), 1-13

    Systematic review.

    ESG, 23 studies included.

    The average total weight loss at 12 months was 16.3%. ESG was associated with a significantly greater weight loss than both intragastric balloon insertion (21.3 versus 13.9% TWL at 12 months, p<0.05) and "high-intensity diet and lifestyle therapy" (20.6 versus 14.3% TWL at 12 months, p<0.05). In contrast, ESG was associated with a significantly lower weight loss than laparoscopic sleeve gastrectomy (17.1 versus 23.6% TWL at 6 months, p<0.05). ESG had a significantly lower rate of adverse events than both laparoscopic sleeve gastrectomy (5.2 versus 16.9%, p<0.05) and intragastric balloon placement (5.2 versus 17%, p<0.05).

    Similar recent assessment included in evidence summary.

    Pizzicannella M, Fiorillo C, Barberio M, et al. Endoscopic assessment of morphological and histopathological upper gastrointestinal changes after endoscopic sleeve gastroplasty. Surg Obes Relat Dis. Published online 2021

    Retrospective analysis (of prospective data).

    N=86 patients who underwent ESG and upper endoscopy.

    Follow-up 12 months.

    At 12 months, %TWL was 14.1% and %EWL was 35.8%. 16 patients had revisions; esophagitis resolved in all but one. Hyperaemic and erosive gastropathy decreased to 17.4% (n=15) and 1.2% (n=1) (p=0.44) H. pylori resolved in all previous cases. ESG does not promote the new onset of macroscopic and histopathologic abnormalities within 1-year follow-up.

    Studies with higher level of evidence included in evidence summary.

    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(8):3696-3705

    Prospective study.

    N=133 patients underwent ESG.

    Follow-up 12 months

    ESG was open in 6, partially intact in 38 and intact in 43 cases at 6 months. The overall %EWL and %TWL was 34.5 and 13.2, respectively; 25.7 and 11.8 for the open group, 30.8 and 12.4 for the partially intact group; 39.1and 14 for the intact group. At 12 months,10 (24%) had an intact ESG, 24 (59%) had a partially intact gastroplasty, and in 7 (17%) cases the sutures were lost. Overall %EWL and %TWL at 12 months was 34.3 and 13.1, 19.3 and 8.9 for the open group; 36.0 and 13.1for the partially intact group; 40.3 and 17.2 for the intact group. Weight loss correlates with ESG endoscopic appearance over time.

    High level evidence included in evidence summary.

    Polese L, Prevedello L, Belluzzi A et al. Endoscopic sleeve gastroplasty: results from a single surgical bariatric centre. Updates in Surgery (2022) 74:1971–1975.

    Prospective study.

    N=27 patients ineligible for bariatric surgery due to comorbidities or low BMI had ESG.

    Mean BMI 36.9 kg/m2.

    Mean follow-up 18 months.

    %TBWL and %EWL were 11 and 39, respectively. The latter was significantly higher in the patients with an initial BMI less than 40. The patients whose gastric sleeve extended for more than a third of the length of the stomach had better results.

    Larger studies included in evidence summary.

    Rapaka B, Maselli DB, Lopez Nava G et al. (2022) Effects on physiologic measures of appetite from intragastric balloon and endoscopic sleeve gastroplasty: results of a prospective study. Chinese Medical Journal;135(10)

    Prospective case series.

    N=41

    IGB 18

    ESG 23

    IGB and ESG both induce weight loss but likely through distinct gastric motor function phenotypes, and gastric emptying may predict future weight loss in patients with IGB.

    Similar comparative studies reporting weight loss as primary outcome were included in evidence summary.

    Runge TM, Juliana Yang J, Fayad L et al. (2020) Anatomical Configuration of the Stomach Post-Endoscopic Sleeve Gastroplasty (ESG)—What Are the Sutures Doing? Obesity Surgery, 30:2056–2060

    Prospective case series.

    N=5 patients who had ESG.

    ESGs were successfully reversed at 3 weeks and 1 month following index ESG without significant fibrosis or scaring. At 8 and 14 months, a few sutures had dehisced though there were extensive areas of fibrosis. By 2 years, most of the sutures had dehisced; however, the gastric volume remained reduced.

    Large studies included in evidence summary.

    Sarkar A, Tawadros A, Andalib I, et al. (2022) Safety And Efficacy Of Endoscopic Sleeve Gastroplasty For Obesity Management In New Bariatric Endoscopy Programs: A Multicenter International Study. Ther Adv Gastrointest Endosc 15: 1–9

    Retrospective analysis.

    N=91 patients who had ESG.

    BMI reduction at 3 months was 7.3 (p<0.000), at 6 months 9.3 (p<0.000), at 12 months 8.6 (p<0.000) from baseline. EBWL was 17.3% at 1 month (p<0.000), 29.2% at 3 months (p<0.000), and 35.6% at 6 months (p<0.000).

    Higher level evidence included in evidence summary.

    Sartoretto A, Sui Z, Hill C, et al. (2018) Endoscopic sleeve gastroplasty (ESG) is a reproducible and effective endoscopic bariatric therapy suitable for widespread clinical adoption: a large, international multicenter study. Obes Surg. 28:1812–21.

    Observational study (retrospective).

    N=112 patients overweight or obese with BMI ranging from 28.5 to 69.0 kg/m2

    Follow-up 6 months

    At 1, 3, and 6 months, absolute weight loss was 9.0 kg (TBWL 8.4%), 12.9 kg (TBWL 11.9%), and 16.4 kg (TBWL 14.9%), respectively. The proportion of patients who attained greater than 10% TBWL and 25% EWL was 62 and 78% at 3 months post-ESG and 81 and 87% at 6 months post-ESG.

    Included in systematic reviews added to evidence summary.

    Saumoy M, Schneider Y, Zhou XK, et al. (2018) A single-operator learning curve analysis for the endoscopic sleeve gastroplasty. Gastrointest Endosc. 2018;87:442–7.

    Observational study (prospective).

    N=128 patients with BMI > 30 kg/m2 with failed non-invasive weight loss measures or BMI > 40 kg/m2 and nonsurgical candidates or declined surgery.

    ESG

    Follow-up 12 months.

    Efficiency for ESG was attained after 38 ESGs, with mastery after 55 procedures. At 12 months, the mean percent total body weight loss was 15.8%. A total of 71.7% of patients achieved successful weight loss.

    Learning curve; included in systematic reviews added to evidence summary.

    Singh S, Hourneaux de Moura DT, Khan A, et al. (2020) Safety and efficacy of endoscopic sleeve gastroplasty worldwide for treatment of obesity: a systematic review and meta-analysis. Surg Obes Relat Dis.16(2): 340–351.

    Systematic review and meta-analysis.

    n=8 observational studies (n=1,859 patients)

    ESG

    Pooled mean %TWL at 6, 12, and 24 months was 14.9 (95% CI 13.8 to 15.9), 16.4 (95% CI 15.2 to 17.6) and 20.0 (95% CI 16.9 to 23.1), respectively. Pooled mean %EWL at 6, 12, and 24 months was 55.8 (95% CI 50.6 to 60.9), 61.8 (95% CI 54.8 to 68.9), and 60.4 (95% CI 48.9 to 71.9), respectively. The pooled incidence of SAE was 2.3% (95% CI 1.3 to 4.0), and no mortality was reported. Gastrointestinal bleeding and peri-gastric fluid collection were the most common reported SAE; however, the pooled incidence of both was less than 1%. Variations in procedural technique were seen, but the full-thickness nature of suturing was reported in all studies. A layer of reinforcement sutures was performed in most studies (n=6).

    More recent comprehensive studies included in the evidence summary.

    Sharaiha RZ, Kumta NA, Saumoy M, et al. Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients. Clin Gastroenterol Hepatol. 2017;15(4):504-510.

    Prospective study.

    N=91 patients with BMI >30 kg/m2 and had failed non-invasive weight loss measures or BMI >40 kg/m2 not suitable or refused surgery.

    Follow-up 24 months

    Mean BMI 40.7 kg/m2. ESG is a minimally invasive and effective endoscopic weight loss intervention. In addition to sustained total body weight loss up to 24 months, ESG reduced markers of hypertension, diabetes, and hypertriglyceridemia.

    Study included in systematic reviews added to evidence summary.

    Sharaiha RZ, Kedia P, Kumta N et al. (2015) Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy; 47: 164–166

    Prospective study.

    N=10 patients with mean BMI 45.2 kg/m2 had ESG.

    Follow-up 6 months.

    There were no significant adverse events noted. After 1 month, 3 months, and 6 months, excess weight loss of 18%, 26%, and 30%, and mean weight loss of 11.5 kg, 19.4 kg, and 33.0 kg, respectively, were observed.

    Large studies included in evidence summary.

    Sowier A, Pyda P, Borucka AM et al. (2018) Initial experience with endoscopic sleeve gastroplasty in Poland. POL PRZEGL CHIR, 90 (4), 36-41.

    Prospective case series.

    N=10 patients with obesity had ESG.

    No severe peri-operative complications. The only adverse event was a minor haemorrhage in 1 patient, which did not need any surgical intervention. Mean %TBWL was 8.6%, 15.4% and 19.6% at 1, 2 and 3 months, respectively.

    Large studies included in evidence summary.

    Yoon JY, Arau RT, and the study group for Endoscopic Bariatric and Metabolic Therapies of the Korean Society of Gastrointestinal Endoscopy. (2021) The Efficacy and Safety of Endoscopic Sleeve Gastroplasty as an Alternative to Laparoscopic Sleeve Gastrectomy. Clin Endosc; 54:17-24.

    Review of efficacy and safety.

    Weight loss for ESG is significantly greater than that of high-intensity diet and lifestyle therapy and lower than that of LSG. Percentage of total body weight loss and excess body weight loss was approximately 16% and 60% at 12 months. The pooled rate of adverse events in several meta-analysis studies ranged from 1.5% to 2.3%. ESG reduced the risk of obesity-related metabolic comorbidities, and even improved quality of life.

    Review