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CLINICAL OUTCOME OF THREE DIFFERENT TECHNIQUES OF ENDOSCOPIC GASTROPLASTY. RESULTS AT 18 MONTHS FOLLOW-UP FROM A SINGLE CENTER, RANDOMIZED CONTROLLED TRIAL
Date
May 19, 2024
Introduction: Endoscopic Gastroplasty (EG) is an endoscopic therapy to treat obese patients focusing on gastric body remodeling. We considered three different techniques: Endoscopic Sleeve Gastroplasty (ESG), Endoluminal Vertical Gastroplasty (EVG), and distal Primary Obesity Surgery Endoluminal (POSE2).
Aims & Methods: This was a single center, randomized controlled trial (ClinicalTrials.gov NCT04854317) of obese patients who underwent EG (through ESG or EVG or POSE2) or a low-calorie Mediterranean diet (1600 and 1400 Kcal/day). Outcomes included technical success rate, serious adverse event rate, and efficacy of the three EG procedures at inducing weight loss, improving obesity related comorbidities and quality of life (QoL), compared to diet.
Results: From July 2020 to May 2022, 240 obese (body mass index 37.5±3.5 kg/m2) patients (mean age 46±10 years; females 87.8%; obesity class II 58.3%; hepatic steatosis as the main comorbidity in 70%) underwent EG (through ESG, EVG or POSE2, with 60 patients for each procedure, 180 patients in total) or a low-calorie diet (60 patients). In the EG group the technical success rate was 100%. The serious adverse event rate was 1.1%. The follow-up visit was attended by 100/180 (55.6%), 48/180 (26.7%) and 19/180 (10.6%) patients at 6, 12 and 18 months, respectively. They experienced 16.1±6.1%, 13.7±9.0% and 14.1±11.0% total body weight loss (TBWL) and 39.7±15.4%, 35.3±23.4% and 34.7±27.3% excess weight loss (EWL) at 6, 12 and 18 months, respectively, with no significant difference among the three techniques in both parameters (p>0.62 in TBWL% and p>0.94 in EWL% ANOVA tests) at 18 months follow-up. Concerning the low-calorie diet group, 31/60 (52%), 13/60 (22%) and 4/60 (6%) patients attended their 6, 12 and 18 months follow-up; they experienced 1.1±4.7% TBWL (p<0.001 versus EG group) and 2.3±9.8% EWL (p<0.001 versus EG group) at 18 months. Ninety seven of one hundred (97.0%), 37/48 (77.1%) and 16/19 (84.2%) patients achieved at least 5% TBWL, while 86/100 (86.0%), 32/48 (66.6%) and 15/19 (78.9%) achieved at least 25% EWL in the EG group at 6, 12 and 18 months follow-up, compared to 4/31 (12.9%), 1/13 (7.6%) and 0/4 (0%), and 3/31 (9.7%), 1/13 (7.6%) and 0/4 (0%) in the diet group, at 6, 12 and 18 months. Fatty liver disease, hypertension, hyperlipidemia, diabetes, and obstructive sleep apnea improved after the EG procedure at 18 months, while no improvement was observed in the diet group. Also, the QoL measured by EQ-5D test improved at 18-month follow-up (p<0.01) in the EG group, while no significant improvement was detected in the diet group.
Conclusion: EG through ESG, EVG and D-POSE are technically feasible and safe, and appear to be effective for the treatment of obese patients, compared to diet, at a medium term follow-up.
Aims & Methods: This was a single center, randomized controlled trial (ClinicalTrials.gov NCT04854317) of obese patients who underwent EG (through ESG or EVG or POSE2) or a low-calorie Mediterranean diet (1600 and 1400 Kcal/day). Outcomes included technical success rate, serious adverse event rate, and efficacy of the three EG procedures at inducing weight loss, improving obesity related comorbidities and quality of life (QoL), compared to diet.
Results: From July 2020 to May 2022, 240 obese (body mass index 37.5±3.5 kg/m2) patients (mean age 46±10 years; females 87.8%; obesity class II 58.3%; hepatic steatosis as the main comorbidity in 70%) underwent EG (through ESG, EVG or POSE2, with 60 patients for each procedure, 180 patients in total) or a low-calorie diet (60 patients). In the EG group the technical success rate was 100%. The serious adverse event rate was 1.1%. The follow-up visit was attended by 100/180 (55.6%), 48/180 (26.7%) and 19/180 (10.6%) patients at 6, 12 and 18 months, respectively. They experienced 16.1±6.1%, 13.7±9.0% and 14.1±11.0% total body weight loss (TBWL) and 39.7±15.4%, 35.3±23.4% and 34.7±27.3% excess weight loss (EWL) at 6, 12 and 18 months, respectively, with no significant difference among the three techniques in both parameters (p>0.62 in TBWL% and p>0.94 in EWL% ANOVA tests) at 18 months follow-up. Concerning the low-calorie diet group, 31/60 (52%), 13/60 (22%) and 4/60 (6%) patients attended their 6, 12 and 18 months follow-up; they experienced 1.1±4.7% TBWL (p<0.001 versus EG group) and 2.3±9.8% EWL (p<0.001 versus EG group) at 18 months. Ninety seven of one hundred (97.0%), 37/48 (77.1%) and 16/19 (84.2%) patients achieved at least 5% TBWL, while 86/100 (86.0%), 32/48 (66.6%) and 15/19 (78.9%) achieved at least 25% EWL in the EG group at 6, 12 and 18 months follow-up, compared to 4/31 (12.9%), 1/13 (7.6%) and 0/4 (0%), and 3/31 (9.7%), 1/13 (7.6%) and 0/4 (0%) in the diet group, at 6, 12 and 18 months. Fatty liver disease, hypertension, hyperlipidemia, diabetes, and obstructive sleep apnea improved after the EG procedure at 18 months, while no improvement was observed in the diet group. Also, the QoL measured by EQ-5D test improved at 18-month follow-up (p<0.01) in the EG group, while no significant improvement was detected in the diet group.
Conclusion: EG through ESG, EVG and D-POSE are technically feasible and safe, and appear to be effective for the treatment of obese patients, compared to diet, at a medium term follow-up.
