Abstract
Background
Endoscopic sutured gastroplasty (ESG) has evolved over time. With the advent of full-thickness endoscopic suturing, an efficient technique for ESG was developed and refined.
Methods
This prospective first-in-man trial started in April 2012 and represents the first use of full-thickness endoscopic suturing for primary obesity therapy. The trial focused on procedure development, reproducibility, safety, and short-term efficacy. The trial was performed at centers in five countries, in three phases. Phase I was evaluation of safety and technical feasibility of various procedure techniques; stitch patterns and sequences were assessed for efficiency, safety, and feasibility. Phase II entailed continued procedure refinement to establish a standardized technique. Phase III entailed evaluation of technical feasibility and weight loss outcomes in 77 patients; the procedure was performed using the standardized technique, and there was no procedure development. Data were prospectively collected into a registry.
Results
In Phase I, the procedure was created and modified to improve time efficiency. Safety and technical feasibility were established, and short-term weight loss was demonstrated. In Phase II, a number of stitch patterns were attempted, and the stitch pattern was modified and finalized. 22 patients were included, and 1-year total weight loss was 17.3 ± 2.6%. In Phase III, conformity with the final technique was high. 77 patients were included, with a mean BMI of 36.1 ± 0.6 kg/m2. Mean weight loss was 16.0 ± 0.8% at 6 months and 17.4 ± 1.2% at 12 months (n = 44). Postprocedural nausea, vomiting, and epigastric pain were frequently reported; there were no reported significant adverse events post-procedure or during the follow-up period.
Conclusions
Following a methodical procedure development phase, ESG demonstrated safety and short-term efficacy in this trial. The procedure also achieved meaningful weight loss during the follow-up period.
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Drs. Abu Dayyeh, Lopez-Nava Breviere, Galvao Neto, Shaikh, Hawes, Gostout, Goenka, Orillac, Alvarado, Zundel, and Thompson received an Institutional clinical research grant from Apollo Endosurgery to perform the procedures in this study. Drs. Abu Dayyeh, Lopez-Nava Breviere, Galvao Neto, Shaikh, Gostout, Zundel, and Thompson are Consultants for Apollo Endosurgery. Drs. Kumar, Sahdala, and Jirapinyo have no conflicts of interest to disclose.
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Kumar, N., Abu Dayyeh, B.K., Lopez-Nava Breviere, G. et al. Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique. Surg Endosc 32, 2159–2164 (2018). https://doi.org/10.1007/s00464-017-5869-2
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DOI: https://doi.org/10.1007/s00464-017-5869-2