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

Stomach Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910974
• Other study ID #: TRESTIS 2013-A00133-42
• Secondary ID: TRESTIS
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: August 29, 2016
• Start date: July 2012
• Est. completion date: February 2014

Study information

• Verified date: July 2012
• Source: Hôpital Edouard Herriot
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intestinal Neoplasm
• Intestinal Neoplasms
• Neoplasms
• Rectal Neoplasm
• Rectal Neoplasms
• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Procedure:
• endoscopic sub-mucosal dissection
endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions

Locations

Country	Name	City	State
France	NESTIS	Lyon	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Edouard Herriot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes