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

Hôpital Edouard Herriot

Status

Completed

Conditions

Rectal Neoplasm

Stomach Neoplasm

Intestinal Neoplasm

Treatments

Procedure: endoscopic sub-mucosal dissection

Study type

Interventional

Funder types

Other

Identifiers

NCT01910974

TRESTIS (Other Identifier)

TRESTIS 2013-A00133-42

Details and patient eligibility

About

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).

Full 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.)

Enrollment

80 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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