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IFSO Consensus on definitions and clinical practice guidelines (part 2)

In part two of our report from Hamburg, topics under discussion endoscopic bariatric procedures including ESG, endobarrier and balloons, endoscopic metabolic and bariatric therapies for metabolically challenged patients and more. The following are the brief highlights from the presentations.

RCT For Class I and II Obesity for Endoscopic Sleeve Gastroplasty

In the ‘Endoscopy for the Treatment of Obesity’ session, Dr Barham Abu Dayyeh (Mayo Clinic) presented data from RCT for class I and II obesity for endoscopic sleeve gastroplasty (ESG) and outlined the role the procedure could have in managing obesity.

He stated that ESG with lifestyle intervention is a recommended management option, over lifestyle interventions alone for patients with Class I and II Obesity (level of evidence 1b/2a), adding that ESG has the advantage that it is more efficacious than lifestyle interventions alone, safe, less burdensome to patients as far as compliance with long-term medications use, and less invasive than the surgical options given its organ-sparing nature.

There is also considerable evidence within the medical literature, with over 15,000 ESG cases showing %TBWL after 36 months of approximately 14% with a pooled serious adverse event rate of 1.25%. Furthermore, one-year outcomes from the Multi-center ESG Randomized Interventional Trial (MERIT-Trial) revealed the mean percentage of EWL was 49.2% for the ESG group vs 3.2% (18.6) for the control (lifestyle) group (p<0.0001). In Addition, 77% of ESG participants reached 25% or more of EWL at 52 weeks vs 13 (12%) of 110 in the control group (p<0.0001). Eighty percent of participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. Three ESG patients (2.0%) experienced a device or procedure-related serious adverse event, all of which resolved and did not require intensive care or surgical intervention.

The ESG procedure has proven durability, as Sharaiha et al (Clin Gastroenterol Hepatol. 2021 May;19(5):1051- 1057.e2.) reported mean TBWL was 15.9% (p<0.001) and 90 and 61% of patients maintained 5 and 10% TBWL, at five years respectively. In addition, Bhandari et al (J Minim Access Surg. 2023 Jan-Mar;19(1):101-106), found 70% of patients maintained EWL of ≥25% at four years. Finally, Gainey et al (presentation at Digestive Disease Week 2022), reveal that total body weight loss of more than 20% was maintained out to three years in patients with class III obesity with improvement in patients with hypertension, hyperlipidaemia and diabetes.

He concluded that ESG is safe and effective for class I and II obesity, with strong levels of evidence and, in his opinion, ESG is as effective and safe as modern AOMs. Indeed, he added that ESG complements other interventions for obesity and augments the spectrum of obesity care.

Endoscopic treatments in adolescents

Evidence supporting endoscopic treatments for obesity in adolescent patients was presented by Dr Christine Stier (Cologne, Germany). These included fluid-filled balloons, gas-filled balloons, endoscopic sleeve gastroplasty (ESG) and duodenal bypass liners (DJBL).

She began by pointing out that the majority of the studies in this group were classified as level 2 evidence. However, the overall evidence is very limited. There are six publications on the fluid-filled balloon and only one or two publications on the other procedures.

Summarising the cumulative results of the six publications on the liquid-filled balloon in patients with a mean age of 16.25 +2.05 years, the treatment resulted in a mean reduction in BMI from 39.85 ± 5.5 to 35.9 ± 5.97 kg/m2 (-3.95 BMI points) and a mean reduction in weight from 119.55 ± 14.84 to 108 ± 18.46 kg (-11.55 kg). Follow-up (FU) was performed six months after the intervention. All trials, but the earliest published retrospective case series from 1999 with only five participants, demonstrated statistically significant weight loss with the fluid-filled balloon. Another exception is the publication by Sallet from 2004 including 21 participants, which only reports the cumulative BMI reduction of 5 points in a prospective study, but did not derive any significance from this.

However, a near significant reduction in BMI (p=0.0717) was suggested by re-examining the values. There were no reports of serious adverse events in any of the studies. In contrast, the prospective studies of the effect of the gas-filled balloon showed no significance for either BMI reduction (36.00 ± 1.03 to 33.97 ± 2.43 kg/ m2 ) or weight loss (97.29 ± 2.13 to 88.32 ± 6.68 kg) in the total of 27 people included. FU was performed three months after the intervention. Significance could only be extrapolated by creating individually defined low-volume subgroups (Nobili 2015 7/10 and De Peppo 2017 8/17). There were no reports of serious adverse events in any of both studies. The only study to look at the effect of the fluid-filled balloon in adolescent patients with Prader-Willi syndrome (PWS) also showed a significant reduction in BMI (47.9+9.3 to 41.3+9.3 kg/m2 ) and weight (105.6+17.2 to 92.5+20.6 kg). However, Stier noted a higher risk profile for balloons for patients with genetic syndromes with hyperphagia as cause of obesity (PWS), compared to treatment of obesity in childhood/adolescent without genetic cause.

In the DJBL study, results showed a significant reduction in BMI (42.5+4.1 to 37.6+3.7 kg/m2 (6MFU) and 38.2+5.3 (12MFU) kg/m2 ) and improvement in insulin resistance (HOMA-IR) over time. Published in 2019, 109 individuals who underwent endoscopic sleeve gastroplasty (ESG) were reported in the study with the most adolescents included. With decreasing numbers of patients, results are reported up to 2 years after the intervention. Both total and excess weight loss remain statistically significant over time. No serious adverse events were reported. Stier said that there is a need for a uniform and interdisciplinary valid classification of obesity in adolescents (based on either BMI, BMI%, >Percentile >95th, >Percentile >97th or age-adjusted BMI). The same is true for the guidelines required based on the defined indications derived from this classification. She also warned that the current evidence is limited by the number of patients studied in the trials to date (87 intragastric balloons, 109 ESGs, DJBL not in clinical use) and that significantly more studies are needed to provide robust evidence for endoscopic treatment in these patients, who are likely to be a preferable target population.

“However, despite the decline in reported follow-up numbers, the therapeutic outcome of ESG appears to be more consistent than that of balloon therapy in the treatment of adolescent obesity,” she concluded.

Endoscopic Metabolic and Bariatric Therapies (EMBT) for metabolically challenged patients

The final presentation in the endoscopic session examined endoscopic metabolic and bariatric therapies (EMBT) for metabolically challenged patients. Dr Christopher Thompson (Brigham and Women’s Hospital & Harvard Medical School) focused on the outcomes from four treatments – intragastric balloons (IGBs), endoscopic sleeve gastroplasty (ESG), dudeno-jejunal bypass liner (DJBL) and duodenal resurfacing.

A systematic review and meta-analysis by Popv et al (Impact of Intragastric Balloons on Obesity-Related CoMorbidities: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2017 Mar;112(3):429-439), assessed the effect of IGBs on metabolic outcomes associated with obesity. From ten randomised controlled trials (RCT) and 30 observational studies (5,668 subjects), they reported moderate-quality evidence for improvement in most metabolic parameters in subjects assigned to IGB therapy vs. conventional non-surgical therapy including an overall decrease in HbA1C of 0.6%, waist circumference -4.1 cm (p=0.003), as well as improvements in hypertension, dyslipidaemia, fasting blood glucose and liver function tests.

However, there was 1.3% rate of serious adverse events, with two deaths and a mortality rate of 0.04%. For ESG, Thompson cited a paper by Sharaiha et al (Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients. Clin Gastroenterol Hepatol. 2017 Apr;15(4):504-510) that evaluates the effects of ESG on total body weight loss and obesity-related comorbidities in 91 patients. They reported that patients had lost 14.4% of their total body weight at six months (80% follow-up rate), 17.6% at 12 months (76% follow-up rate) and 20.9% at 24 months (66% follow-up rate) after ESG. At 12 months, patients had statistically significant reductions in levels of hemoglobin A1c (p=0.01), systolic blood pressure (p=0.02), waist circumference (p<0.001), alanine aminotransferase (p<0.001) and serum triglycerides (p=0.02). However, there was no significant change in low-density lipoprotein after vs before ESG (p=0.79). There was one serious adverse event (1.1%, perigastric leak) that occurred that was managed nonoperatively.

Another study by Hajifathalian et al (Improvement in insulin resistance and estimated hepatic steatosis and fibrosis after endoscopic sleeve gastroplasty. Rachel Batterham and Dror Dicker Gastrointest Endosc. 2021 May;93(5):1110-1118) in 118 patients reported total body weight loss was 15.5%, hepatic steatosis index score improved significantly, decreasing by 4 points per year (p for trend, <0.001). Patients’ NAFLD fibrosis scores improved significantly, decreasing by 0.3 points per year (p for trend, 0.034). Twenty-four patients (20%) improved their risk of hepatic fibrosis from F3-F4 or indeterminate to F0-F2, whereas only one patient (1%) experienced an increase in the estimated risk of fibrosis (p=0.02).

Moreover, outcomes from the MERIT RCT (Abu Dayyeh et al. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. 2022 Aug 6;400(10350):441-451) reported EWL of 49.2% for the ESG group vs. 3.2% for the control group (p<0.0001), and total body weight loss was 13.6% for the ESG group vs. 0.8% for the control group (p<0.0001), at one year. At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, vs. the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL.

A meta-analysis on DJBL by Jirapinyo et al (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 May;41(5):1106-1115) found at explant, HbA1c decreased by 1.3% and HOMA-IR decreased by 4.6. At explant, patients lost 11.3 kg corresponding to a BMI reduction of 4.1 kg/m2 , total weight loss of 18.9% and excess weight loss of 36.9% [29.2, 44.6]. Regarding duodenal mucosal resurfacing (DMR), Mingrone et al (Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, doubleblind, sham-controlled, multicentre REVITA-2 feasibility trial. Gut 2022;71:254- 264) reported that the procedure resulted in a greater reduction in HbA1c in the DMR group vs. sham in the European cohort and a greater reduction in MRI-PDFF in the DMR group vs. sham in the European cohort (baseline MRI-PDFF >5%). Total weight loss was also greater in the entire DMR cohort (2.8%( vs sham ((1.8% TWL (sham, p=0.037).

Overall, Thompson said EMBT appear to be effective in treating obesity-related comorbidities with IGB and ESG appears to be effective at improving HbA1c, hypertension, LFTs and dyslipidaemia in patients with obesity (Level 1b and 2a), duodenal-jejunal bypass liner appears to be effective in improving HbA1c in patients with obesity and concomitant T2DM (Level 1b and 2a) and DMR appears to be effective in improving HbA1c in patients with T2DM, in European populations (Level 1b).


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