Gastrointestinal endoscopy · 2025
Effects of different techniques of endoscopic gastroplasty on weight loss among patients with obesity: a randomized, single-center pragmatic trial.
СтатьяРандомизированное исследованиеPragmatic Clinical TrialСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Vadalà di Prampero Salvatore F, Geraci Marco, Cosseddu Valentina, Rocchi Chiara, Bazzu Paola, Simonelli Ilaria, Fiorani Marcello, Formichetti Jessica, Manzoni Gabriella, Di Maio Federica, Massidda Marco, Masia Simona, Puci Mariangela, Sotgiu Giovanni, Milano Valentina, Mancini Maria A, Rinaldi Pierluigi M, Giustacchini Piero, Costamagna Guido, Bulajic Milutin
Аннотация
BACKGROUND AND AIMS: Obesity is a global pandemic requiring effective interventions. Endoscopic bariatric therapies are minimally invasive alternatives to surgery. We compared 3 techniques of endoscopic gastroplasty (EG): endoscopic sleeve gastroplasty (ESG) (Apollo OverStitch SX; Boston Scientific, Marlborough, Mass, USA), endoluminal vertical gastroplasty (EVG) (Endomina; EndoTools Therapeutics, Gosselies, Belgium), and primary obesity surgery endoluminal-2 (POSE-2) (Incisionless Operating Platform; USGI Medical, San Clemente, Calif, USA).
METHODS: This was a single-center, randomized pragmatic study (ClinicalTrials.govNCT04854317) involving patients who underwent EG through ESG, EVG, or POSE-2. The primary end point was the percentage of total body weight loss (TBWL), with secondary end points assessing excess weight loss (EWL), safety, feasibility, anthropometric changes, metabolic, and quality of life (QoL) improvements.
RESULTS: Between April 2021 and May 2023, 184 patients with obesity (body mass index, 36.5 ± 3.0 kg/m2) underwent EG. Follow-up rates were 56% at 6 months, 32% at 12 months, and 15% at 18 months. At 6, 12, and 18 months, patients experienced, respectively, TBWL of 15.5% ± 6.0%, 14.5% ± 8.5%, and 17.1% ± 10.2%, respectively, and EWL of 39.3% ± 15.5%, 36.7% ± 21.4%, and 43.0% ± 26.6%, with no statistically significant differences among the 3 techniques for both parameters (P ≥ .36). The technical success rate was 100%. The serious adverse event rate was 1.1%. Anthropometric measurements, body composition, fatty liver disease, and hyperlipidemia improved at 6-, 12-, and 18-month follow-up, as well as the QoL measured by bariatric analysis and reporting outcome system and SIO-Obesity correlated Disability Test (P < .01).
CONCLUSIONS: This study underscores the potential of EG through ESG, EVG, and POSE-2 as equally effective, safe, and feasible interventions for managing obesity at a medium-term follow-up. The results were consistent despite incomplete follow-up, the main study limitation, assuming that data were missing at random.
METHODS: This was a single-center, randomized pragmatic study (ClinicalTrials.govNCT04854317) involving patients who underwent EG through ESG, EVG, or POSE-2. The primary end point was the percentage of total body weight loss (TBWL), with secondary end points assessing excess weight loss (EWL), safety, feasibility, anthropometric changes, metabolic, and quality of life (QoL) improvements.
RESULTS: Between April 2021 and May 2023, 184 patients with obesity (body mass index, 36.5 ± 3.0 kg/m2) underwent EG. Follow-up rates were 56% at 6 months, 32% at 12 months, and 15% at 18 months. At 6, 12, and 18 months, patients experienced, respectively, TBWL of 15.5% ± 6.0%, 14.5% ± 8.5%, and 17.1% ± 10.2%, respectively, and EWL of 39.3% ± 15.5%, 36.7% ± 21.4%, and 43.0% ± 26.6%, with no statistically significant differences among the 3 techniques for both parameters (P ≥ .36). The technical success rate was 100%. The serious adverse event rate was 1.1%. Anthropometric measurements, body composition, fatty liver disease, and hyperlipidemia improved at 6-, 12-, and 18-month follow-up, as well as the QoL measured by bariatric analysis and reporting outcome system and SIO-Obesity correlated Disability Test (P < .01).
CONCLUSIONS: This study underscores the potential of EG through ESG, EVG, and POSE-2 as equally effective, safe, and feasible interventions for managing obesity at a medium-term follow-up. The results were consistent despite incomplete follow-up, the main study limitation, assuming that data were missing at random.