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

N/ACompletedNCT01910974

Hôpital Edouard Herriot80 enrolled

Overview

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.)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stomach Neoplasm Intestinal Neoplasm Rectal Neoplasm

Interventions

endoscopic sub-mucosal dissectionPROCEDURE

endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

NESTIS

Lyon, Auvergne-Rhône-Alpes, France

Outcomes

Primary Outcomes

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

Time frame: 18 months

Data from ClinicalTrials.gov

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