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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01910974

Enrollment

Registered

2013-07-30

Start date

2012-07-31

Completion date

2014-02-28

Last updated

2016-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Neoplasm, Rectal Neoplasm, Stomach Neoplasm

Keywords

oesophagus, stomach, intestine, rectum

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.)

Interventions

PROCEDUREendoscopic sub-mucosal dissection

endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026