TY - JOUR
T1 - Endoscopic sutured gastroplasty
T2 - procedure evolution from first-in-man cases through current technique
AU - Kumar, Nitin
AU - Abu Dayyeh, Barham K.
AU - Lopez-Nava Breviere, Gontrand
AU - Galvao Neto, Manoel P.
AU - Sahdala, Nicole P.
AU - Shaikh, Sohail N.
AU - Hawes, Robert H.
AU - Gostout, Christopher J.
AU - Goenka, Mahesh K.
AU - Orillac, Jorge R.
AU - Alvarado, Alonso
AU - Jirapinyo, Pichamol
AU - Zundel, Natan
AU - Thompson, Christopher C.
N1 - Publisher Copyright:
© 2017, Springer Science+Business Media, LLC.
PY - 2018/4/1
Y1 - 2018/4/1
N2 - 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/m 2 . 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.
AB - 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/m 2 . 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.
KW - Bariatric endoscopy
KW - Bariatric surgery
KW - Endoscopic bariatric
KW - Endoscopic sleeve gastroplasty
KW - Endoscopic sutured gastroplasty
KW - Obesity
KW - Weight loss surgery
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U2 - 10.1007/s00464-017-5869-2
DO - 10.1007/s00464-017-5869-2
M3 - Article
AN - SCOPUS:85032342413
SN - 0930-2794
VL - 32
SP - 2159
EP - 2164
JO - Surgical endoscopy
JF - Surgical endoscopy
IS - 4
ER -