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

Not Applicable

Completed

• Conditions: Stomach Neoplasm; Rectal Neoplasm; Intestinal Neoplasm
• Interventions: Procedure: endoscopic sub-mucosal dissection

• Registration Number: NCT01910974
• Lead Sponsor: Hôpital Edouard Herriot

Brief 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.)

Study Timeline

• Status Verified: 2012-07
• Study Start: 2012-07
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-30
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endoscopic sub-mucosal dissection	endoscopic sub-mucosal dissection	-

Primary Outcome Measures

Name	Time	Method
SAFETY THAT IS TO SAY PERFORATION RATE AND delayed BLEEDING ONE	18 months	inclusion duration is about 6 months the following period will be about 12 months so a total duration of 18 months

Trial Locations

Locations (1)

NESTIS; 🇫🇷 Lyon, Rhone Alpes, France