Introduction

Endoscopic Gastroplasty (EG) is an endoscopic therapy focusing on gastric body emodeling to treat obese patients. Nowadays three different techniques are mainly described in literature: endoscopic sleeve gastroplasty (ESG) with an overstitch endoscopic suturing device, endoluminal vertical gastroplasty (EVG) with a triangulation platform and endoluminal suturing device, and distal primary obesity surgery endoluminal (POSE-2) with an endoscopic plication system.

Aims & Methods

Our study aimed to assess changes in anthropometric measurements (AM), body composition (BC) and quality of life (QoL) of these three EG techniques at 6 months follow-up. This was a single center, randomized study (ClinicalTrials.gov NCT04854317) of patients who underwent EG (through ESG performed by Apollo Overstitch Sx, or EVG performed by Endomina, or gastric plication performed by POSE-2) for the treatment of obesity. Outcomes included the efficacy of the three EG procedures at inducing weight loss, improving body circumferences (arm, waist, hip and calf), BC (fat mass (FM), free fat mass (FFM), body cell mass (BCM)), and QoL.

Results

Between July 2020 and October 2021, 90 obese (body mass index 36.6 ± 3.1 kg/m2) patients (mean age, 46 ± 10 years; females 87.5%; obesity class II as the main obesity class in 58.3% cases; hepatic steatosis as the main comorbidity with a 70% frequency) underwent EG through ESG or EVG or POSE-2. At 6 months, 63/90 (70%) patients attended their follow-up visit. They experienced 16% ± 6% total body weight loss (TBWL) and 39.7% ± 14.9% excess weight loss (EWL). Sixty out of sixty-three (95.2%) patients achieved at least 5% TBWL, and 54/63 (85.7%) achieved at least 25% EWL. All the body circumferences homogeneously decreased (p<0.001). Concerning BC, the FM and FM% significantly decreased (p<0.001), while the FFM% and BCM% increased (p<0.01). The QoL measured by BAROS test improved at 6-month follow-up (p<0.01).

Conclusion

EG through ESG, EVG and POSE-2, focusing on gastric body reduction and sparing the fundus and antrum, appears to be effective for the treatment of obese patients inducing weight loss and improving the other AM, BC and QoL.

Disclosure

Consultant of: Apollo Endosurgery, USGI Medical, Endotools.

Introduction

With the global rise in obesity, endoscopic bariatric therapy (EBT) is increasingly adopted as a less invasive alternative to surgery. Among the most commonly used approaches are space-occupying techniques via intragastric balloons (IGB) and restrictive methods like endoscopic gastroplasty (EG).

Aims & Methods

This study aimed to evaluate changes in anthropometric parameters and body composition following EBT, and to identify early predictors of weight loss associated with these procedures. This analysis combined data from two single-center, randomized trials involving obese patients undergoing EBT using either IGB (ClinicalTrials.gov NCT06673550) or EG (ClinicalTrials.gov NCT04854317). The primary outcome was the effect of EBT on body circumferences (arm, waist, hip, calf) and body composition metrics including fat mass (FM), fat-free mass (FFM), and body cell mass (BCM). The secondary outcome focused on identifying predictive factors for weight loss. The 6-month follow-up was chosen for assessment, corresponding to the standard IGB removal timeline.

Results

Between July 2020 and January 2024, 318 obese patients were included: 156 received IGB (mean age 46±14 years; 69.2% female; mean BMI 41.9±9.1 kg/m²; 53.0% with class III obesity), while 162 underwent EG (mean age 46±10 years; 87.5% female; mean BMI 36.6±3.1 kg/m²; 58.3% with class II obesity). Follow-up at 6 months was completed by 93.5% in the IGB group (146/156) and 70.4% in the EG group (114/162). Average total body weight loss (TBWL) was 14.2±7.1% for IGB and 16±6% for EG, with corresponding excess weight loss (EWL) of 30.8±23.3% and 39.7±14.9%, respectively. Both groups showed significant reductions in all body circumferences (p<0.001). FM and FM% decreased markedly (p<0.001), while FFM% (p<0.001) and BCM% (p<0.05) increased. In the EG group, linear regression revealed a significant correlation between phase angle and both TBWL (r=0.327, p<0.05) and EWL (r=0.274, p<0.05), a relationship not observed in the IGB group. This difference may be due to distinct baseline characteristics, particularly BMI, and the differing mechanisms of action between the two EBT modalities.

Conclusion

Both IGB and EG demonstrated effectiveness in promoting weight loss, reducing body measurements, and improving body composition in obese patients. Phase angle may serve as a valuable predictor of weight loss in certain EBT approaches, suggesting its potential role in guiding personalized obesity treatment strategies.

Disclosure

Dr Vadalà di Prampero and Dr Milutin Bulajic are consultants for Apollo Endosurgery, EndoTools Therapeutics and USGI Medical.

Introduction

Endoscopic Gastroplasty (EG) is an endoscopic therapy focusing on gastric body remodeling to treat obese patients. Nowadays three different techniques are mainly described in literature: endoscopic sleeve gastroplasty (ESG) with an overstitch endoscopic suturing device, endoluminal vertical gastroplasty (EVG) with a triangulation platform and endoluminal suturing device, and distal primary obesity surgery endoluminal (POSE-2) with an endoscopic plication system.

Aims & Methods

Our study aimed to assess changes in weight loss of these three EG techniques at 6 months follow-up, looking at some useful parameters which could predict these changes. This was a single center, randomized study (ClinicalTrials.gov NCT04854317) of patients who underwent EG (through ESG performed by Apollo Overstitch Sx, or EVG performed by Endomina, or gastric plication performed by POSE-2) for the treatment of obesity. Outcomes included the efficacy of the three EG procedures at inducing weight loss, measured by the percentage of Total Body Weight Loss (%TBWL) and Excess Weight Loss (%EWL).

Results

Between July 2020 and October 2021, 90 obese (body mass index 36.6 ± 3.1 kg/m2) patients (mean age, 46 ± 10 years; females 87.5%; obesity class II as the main obesity class in 58.3% cases; hepatic steatosis as the main comorbidity with a 70% frequency) underwent EG through ESG or EVG or POSE2. At 6 months, 63/90 (70%) patients attended their follow-up visit. They experienced 16% ± 6% TBWL and 39.7% ± 14.9% EWL, with no significant difference among the three techniques in both of parameters (p>0.62 in TBWL and p>0.94 in EWL ANOVA tests). Sixty out of sixty-three (95.2%) patients achieved at least 5% TBWL, and 54/63 (85.7%) achieved at least 25% EWL. All the body circumferences homogeneously decreased (p<0.001). By a linear regression analysis, at 6 months follow-up a significant correlation between the Phase Angle and the %TBWL (p<0.05) and %EWL (p<0.05) was detected.

Conclusion

Our study confirms that ESG, EVG and POSE-2 are valuable EG procedures to reduce weight in obese patients. The Phase Angle could be considered a useful predictor of weight loss after the EG, at least in the short-term. Detecting valuable predictors of weight loss could be helpful not only in the post-operative, but also and mainly in the pre-operative to tailor a specific intervention for each patient according to the emerging concept of personalized therapy for obesity. Further studies with more patients and a longer follow-up are needed to confirm our data.

Disclosure

Consultant of: Apollo Endosurgery, USGI Medical, Endotools.

Introduction

Aims & Methods

Results

Conclusion

Disclosure

Introduction

Endoscopic sleeve gastroplasty (ESG) is established as effective and mini-invasive procedure for obesity. Patients undergoing bariatric procedures in 80% of the cases are females. It is known that gender plays a role in several metabolic networks related to obesity; however no studies have investigated the gender impact on obesity after ESG.

Aims & Methods

To evaluate the gender impact on long-term weight loss outcomes after ESG in patients treated in our bariatric unit. We analyzed 160 patients that underwent ESG at Fondazione Policlinico Gemelli IRCCS from mese 2017 to mese 2021. A matched-pair analysis between the two groups for baseline BMI, age, and timing of the procedure was done. Weight loss outcomes were described in terms of total body weight (TBWL%) and excess weight loss (EWL%) at 12, 24 and 30 months.

Results

We found that men presenting for ESG had a higher body mass index (BMI) than women (40,7 kg/m² vs 39,8 kg/m²). After ESG the TBWL% in female at 12, 24, and 30 months was 17,2%, 14,0% and 15,2% compared to 14,9%, 14,3% and 9,6% in men, respectively. The EWL% was 48,4%, 39,6% and 41,7%, compared to 41,9%, 39,5% and 24,3% in men, respectively.

Conclusion

Women have more durable weight loss compared to men. More in depth studies are needed to understand the cause of this difference.

Introduction

Obesity is a chronic and recurrent disease. In the past few years, Endoscopic sleeve gastroplasty (ESG) has emerged as a minimally invasive technique to fill the therapeutic gap between medical and surgical approaches to obesity. ESG consists of full-thickness suturing of the gastric body to restrict gastric volume and impair gastric motility. Most of the published data on ESG are limited to 12-24 months^1-6. In this study, we aim to report long-term results of ESG to implement further the evidence of long-term effectiveness in each BMI class.

Aims & Methods

A post-hoc analysis was performed on a prospective database including patients with obesity (BMI ≥ 30 kg/m²) who underwent ESG between May 2017 and May 2021 at a single tertiary Center. Before ESG, all patients were evaluated and identified as eligible for the bariatric procedure by the local bariatric multidisciplinary team. Weight loss outcomes (%EWL, %TBWL) were evaluated during follow-up and stratified according to obesity class. We evaluated the percentage of patients achieving %EWL>25%, the current threshold defining the efficacy of a primary bariatric endoscopic procedure^​7, as well as percentage of patients achieving %TBWL>10%, the minimum threshold associated with obesity-related comorbidities improvement⁸. All patients were included in a multidisciplinary follow-up scheduled at 1, 3, 6, and then every 6 months, as per routine clinical practice.

Results

Between May 2017 and May 2021, 252 subjects (73% Female) underwent ESG with a median BMI of 37.2 (35.3-40.8) kg/m² at baseline and a median age of 45 (36-54) years. No severe procedure-related adverse events occurred. Of 252 subjects, 58 (23%) had obesity class I (BMI 30-34.9), 120 (48%) had obesity class II (BMI 35-39.9), and 74 (29%) had class III obesity (BMI ≥ 40). Follow-up rate was 90.5% (228/252) at 12 months, 60.3% (152/252) at 24 months, and 30.2% at 30-36 months. Overall, 58% (44/76) of patients showed an %EWL>25% at 30-36 months of follow-up, respectively. Similarly, 71% (54/76) of subjects showed a %TBWL> 5% 30-36 months after ESG. Weight loss results according to BMI class are reported in Table 1.

Conclusion

Despite limited by the follow-up loss, a common issue in clinical pratice for obesity cohorts, our experience confirms that ESG in the setting of a multidisciplinary approach is a safe and effective procedure for the treatment of obesity, associated with sustained weight loss in all obesity classes.

References

1. 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 Off Clin Pract J Am Gastroenterol Assoc. 2017;15(4):504-510.
2. 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.
3. Graus Morales J, Crespo Pérez L, Marques A, et al. Modified endoscopic gastroplasty for the treatment of obesity. Surg Endosc. 2018;32(9):3936-3942.
4. Alqahtani A, Al-Darwish A, Mahmoud AE, Alqahtani YA, Elahmedi M. Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients. Gastrointest Endosc. 2019;89(6):1132-1138.
5. 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(5):1051-1057.e2.
6. 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 Lond Engl. 2022;400(10350):441-451.
7. Ginsberg GG, Chand B, Cote GA, et al. A pathway to endoscopic bariatric therapies. Gastrointest Endosc. 2011;74(5):943-953.
8. Ryan DH, Yockey SR. Weight Loss and Improvement in Comorbidity: Differences at 5%,10%,15%, and Over. Curr Obes Rep. 2017;6(2):187-194.