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DOI: 10.1055/s-0040-1704163
GASTRIC ENDOSCOPIC SLEEVE PLICATION (GESP): AN INTERNATIONAL MULTICENTER PROSPECTIVE TRIAL
Publication History
Publication Date:
23 April 2020 (online)
Aims Obesity is a major desesase, endoscopic procedures are becoming important tool for obesity treatment. The Gastric Endoscopic Sleeve Plication (GESP) procedure, performed using the Incisionless Operating Platform (IOP) (USGI, San Clemente, CA), involves a new pattern of full-thickness gastric plications with durable suture anchor pairs that both shortens and tabularizes the greater curvature of the stomach . This international, protocol-driven, prospective multicenter trial examined the impact of the safety and efficacy of the GESP procedure.
Methods 41 patients enrolled under an IRB protocol in three centers (2 Spain, 1 US under an FDA IDE). The same moderate intensity lifestyle intervention and follow-up implemented across all centers. Impact on satiety and satiation was measured using standardized questionnaires. Hepatic steatosis was measured via controlled attenuation parameter (CAP) with transient elastography.
Results 41 subjects (mean age 44.3±9.4 years, mean body mass index 37.3±1.7 kg/m2, 61% female) underwent GESP with 19 (IQR 13-21) suture anchor pairs. Mean procedural time was 37min ± 11min under general anesthesia. Percent total body weight loss (TBWL) was 17.53±6.59% at 9 months (n =32/33). Only one patient was lost to follow-up. No serious adverse events reported. Fasting and post-prandial satiety and satiation scores improved significantly at 2 and 6 months compared to baseline (p < 0.001) Alanine aminotransferase (n =36) improved from a baseline of 33.4 mg/dL to 19.1 mg/dL at 6 months (p = 0.0074), with a corresponding improvement in hepatic steatosis from a baseline CAP (n=15) of 299 dB/m to 220 dB/m at 6 months (p = 0.00024).
Conclusions GESP is a minimally invasive, effective, scalable, and durable procedure that targets multiple physiologic appetite pathways. It offers a real therapeutic option to fill the obesity management gap.
We also can see the metabolic effect of the procedure with improvement of hepatic function.
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