Stomach Neoplasm Clinical Trial
Official title:
TRESTIS: Multicentric Study With a Curative Endoscopic Treatment of Superficial Neoplasia of a Digestive Tract by Endoscopic Submucosal Dissection: Evaluation of a New Water Jet System Injecting Glycerol Mix
safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).
Evaluation of the ability of this system to have a complete resection of superficial tumors
of the digestive tract (that is to say a resection with free lateral and deep margins
without residual tumor tissue)
Evaluation of the ability of such system to inject a viscous macromolecular solution of
glycerol (glycerol mix: Glycerol 10 %, Fructose 5 %, saline solution 0.9%)(27. Fujishiro M,
Yahagi N, Kashimura K, et al. Comparison of various submucosal injection solutions for
maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy.
2004;36:579-583.)
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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