RESUMEN
Endoscopic suturing has been described in many applications, including the approximation of tissue defects, anchoring stents, hemostasis, and primary and secondary bariatric interventions. Primary endobariatric procedures use endoscopic suturing for gastric remodeling with the intention of weight loss. Currently, the only commercially available device in the United States is the OverStitch endoscopic suturing system (Apollo Endosurgery). We describe devices of potential that are currently in design and/or trials as devices for weight loss by gastric remodeling, including USGI incisionless operating platform used for the primary obesity surgery endoluminal 2.0 procedure, Endomina used for the Endomina endoscopic sleeve gastroplasty, and EndoZip.
Asunto(s)
Técnicas de Sutura , Humanos , Técnicas de Sutura/instrumentación , Cirugía Bariátrica/instrumentación , Cirugía Bariátrica/métodos , Cirugía Bariátrica/tendencias , Endoscopía Gastrointestinal/métodos , Endoscopía Gastrointestinal/instrumentación , Endoscopía Gastrointestinal/tendencias , Diseño de EquipoRESUMEN
INTRODUCTION: Endoscopic gastroplasty and gastric volume reduction techniques have been shown to achieve significant weight loss and improvement in comorbid conditions. The objective of this study is to assess the feasibility and safety of a novel fully automated, operator-independent endoscopic suturing system (EndoZip™) for minimally invasive treatment of obesity. DESIGN: Single-center pilot feasibility study. PATIENTS: Eleven patients with a body mass index (BMI) of 30 to 40 kg/m2 with or without obesity-associated comorbidity. INTERVENTIONS: Gastric volume reduction with EndoZip™ system. MAIN OUTCOME MEASUREMENTS: Primary outcome was to assess the technical feasibility and safety. The secondary outcome was to determine %total body weight loss (TBWL) and %excess weight loss (EWL) at 6 months. RESULTS: The mean ± SD age was 42.7 ± 5.6 years, and the mean ± SD BMI was 36.9 ± 2.8 kg/m2. A majority (64%) were men. The procedure was technically successful (100%) in all patients. A median of 3 (range, 2-4) full-thickness sutures were placed, and the mean procedure time was 54.6 ± 23.9 (23-100) min. No immediate complications occurred, and all were discharged in 24 h. One patient developed respiratory infection 3 days after the procedure and required hospitalization. The infection was mild and resolved with antibiotic treatment. At 6-month follow-up, the mean ± SD TBWL, %TBWL, and %EWL were 17.8 ± 6.7 kg, 16.2 ± 6.0%, and 54.3 ± 28.4%, respectively (p < 0.001). LIMITATIONS: Limited number of patients. CONCLUSION: Our first-in-human study showed that the Endozip™ device could be safely used for the treatment of obesity. The early weight loss results are promising. An extended feasibility study on a larger sample size is being planned (Clinicaltrials.gov. NCT03472196).