NCT01910974

Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hôpital Edouard Herriot · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.)

Conditions

• Stomach Neoplasm
• Intestinal Neoplasm
• Rectal Neoplasm

Interventions

Type	Name	Description
PROCEDURE	endoscopic sub-mucosal dissection	endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-07-30
• Last updated: 2016-08-30

Locations

1 site across 1 country: France