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Clinical Trial
. 2018 Apr;32(4):2159-2164.
doi: 10.1007/s00464-017-5869-2. Epub 2017 Oct 26.

Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique

Nitin Kumar  1 , Barham K Abu Dayyeh  2 , Gontrand Lopez-Nava Breviere  3 , Manoel P Galvao Neto  4 , Nicole P Sahdala  5 , Sohail N Shaikh  6 , Robert H Hawes  7 , Christopher J Gostout  2 , Mahesh K Goenka  8 , Jorge R Orillac  9 , Alonso Alvarado  9 , Pichamol Jirapinyo  10 , Natan Zundel  11 , Christopher C Thompson  12   13
Affiliations
Clinical Trial

Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique

Nitin Kumar et al. Surg Endosc. 2018 Apr.

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.

Keywords: Bariatric endoscopy; Bariatric surgery; Endoscopic bariatric; Endoscopic sleeve gastroplasty; Endoscopic sutured gastroplasty; Obesity; Weight loss surgery.

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Conflict of interest statement

Disclosures

Drs. Kumar, Sahdala, and Jirapinyo have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
(A) Endoluminal vertical gastroplasty (B) TRIM procedure (C) ESG with interrupted stitches (D) Final ESG technique
Figure 2
Figure 2
Stitch pattern for sleeve formation
Figure 3
Figure 3
Sleeve formation
Figure 4
Figure 4
(A) Upper gastrointestinal series after ESG, and 3 months after ESG (B) Upper gastrointestinal series after ESG, and 10 months after ESG
See this image and copyright information in PMC

References

    1. The GBD 2013 Obesity Collaboration. Ng M, Fleming T, et al. Global, regional and national prevalence of overweight and obesity in children and adults 1980–2013: A systematic analysis. Lancet (London, England) 2014;384(9945):766–781. doi: 10.1016/S0140-6736(14)60460-8. - DOI - PMC - PubMed
    1. Johnson EE, Simpson AN, Harvey JB, Lockett MA, Byrne KT, Simpson KN. Trends in bariatric surgery, 2002–2012: do changes parallel the obesity trend? Surg Obes Relat Dis. 2016 Feb;12(2):398–404. - PubMed
    1. Thompson CC, Carr-Locke DL, Saltzman J. Peroral endoscopic repair of staple-line dehiscence in Roux-en-Y gastric bypass: a less invasive approach [abstract] Gastroenterology. 2004;126(Suppl 2)
    1. Brethauer SA, Chand B, Schauer PR, Thompson CC. Transoral gastric volume reduction as intervention for weight management: 12-month follow-up of TRIM trial. Surg Obes Relat Dis. 2012 May-Jun;8(3):296–303. - PubMed
    1. Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51–8. - PubMed

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