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

Study Overview
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Brief Summary
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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
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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.)

Official Title
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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

Conditions
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Stomach Neoplasm, Intestinal Neoplasm, Rectal Neoplasm

Intervention / Treatment
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* Procedure: endoscopic sub-mucosal dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OVER 18 YEARS OLD PATIENTS AGREED WITH THE STUDY SCORE ASA 1 OR 2 Patient recorded in a social safety organism patients presenting with superficial lesions with an endoscopic indication of resection Exclusion Criteria: under 18 years old Patients not agreed with the study pregnant women patient included in an another study medical treatments (radiotherapy, surgery endoscopis treatements) before the intervention coagulation disorders score asa over 3 patients with another neoplasic lesion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endoscopic sub-mucosal dissection<br> | Procedure: endoscopic sub-mucosal dissection<br>* endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAFETY THAT IS TO SAY PERFORATION RATE AND delayed BLEEDING ONE | inclusion duration is about 6 months the following period will be about 12 months so a total duration of 18 months | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oesophagus, stomach, intestine, rectum