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DOI: 10.1055/s-0039-1681323
ENDOSCOPIC SLEEVE PLICATION (ESP) FOR TREATMENT OF OBESITY I-II. PRELIMINARY RESULTS OF 2 SITES WITH THE NEW PATTERN FOR GASTRIC EMPTYING DELAY
Publication History
Publication Date:
18 March 2019 (online)
Aims:
Obesity is major disease in our society. Intragastric balloon is the endoscopic gold standard on short time weight loss. Endoscopic plicature can offer us better middle long term results than balloon for its durability.
Methods:
This is a multi-center, prospective pilot study intended to evaluate the safety and efficacy of the Endoscopic Sleeve Plication procedure (mid & distal body plications) (ESP).
Study was Ethics approved at institutions. Written consent obtained. Indications have been obesity grade II. Use of the Incisionless Operating Platform (IOP) TM (USGI Medical, San Clemente, CA, USA) with a defined new pattern of disposition of the transmural plications with the g-cath EZ suture anchors in the greater curvature shortening and tubulizing the stomach to potentially delay gastric emptying and reduce gastric volume/accommodation for an enhanced physiological effect.
Follow up data will be obtained prospectively every 2 weeks initially for the first 2 months and then monthly for the next 10 months on as part of our long term follow-up program that also emphasized changes in unhealthy eating/lifestyle habits.
Results:
17 operations in 17 patients were successfully performed (M: 9 F: 8). Mean age was 44.1 (25 – 59). Mean BMI 37.4 (Range 35.2 – 40.0). Mean number of anchors placed was 18.6 (range 14 – 21). All patients were discharged ≤24 hours. There were no serious adverse events (SAE). % Mean Total body weight loss at 2 months for the 17 patients was 11.17 ± 2.33 Kg and the % Excess Weight loss at 2 months was 34.26 ± 8.23%. All patients reported less hunger and earlier satiety post-procedure.
Conclusions:
The ESP procedure seems to be a safe intervention without significant adverse effects to date. Initial results in weight loss are encouraging. However, long term follow-up and further study remains necessary to assess its value in treating the multi-factorial etiology of obesity.