NESTIS: Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT01913223

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

ESD (Endoscopic Sub-mucosal Dissection)is the first-intent method to treat superficial neoplasms of the digestive tract at it allows an en-bloc R0 resection. Following marking of the lesion margins, ESD comprises 3 steps: 1) liquid injection into the sub-mucosal space 2) circumferential (complete or partial) incision and 3) dissection of the submucosa. Several tools are necessary to perform ESD with the standard technique. Development of water jet with bi functional (injection and cutting) catheter allows time and significant reduction of perforation risk (due to multiple changes of instruments). For this purpose, Nestis introduced the Enki 2 pulsed jet technology with high pressure system to inject efficiently and at any time viscous solutions in direct viewing and retroflexion. Preliminary pig studies indicate that injection of glycerol, hyaluronate and hydroxyethlstarch with Enki 2 are possible. In addition, preclinical studies on living pig colon models using saline solutions have demonstrated that perforation rates and operating times are significantly reduced compared to a standard electrosurgical knife. The present clinical study is being performed to confirm this system capability to perform ESD in humans.

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus Intestinal Dysplasia Esophageal Dysplasia Colorectal Neoplasms	Device: Nestis® jet injector system with a bi-functional catheter	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial.

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: submucosal dissection by dissector water jet	Device: Nestis® jet injector system with a bi-functional catheter

Arm

Intervention/Treatment

Experimental: submucosal dissection by dissector water jet

Device: Nestis® jet injector system with a bi-functional catheter

Outcome Measures

Primary Outcome Measures

Safety outcome [At 1 month]
Safety is measured in term of perforation rate and bleeding rate with immediate complication or delayed one after the procedure, at one month complications are not linked to the ESD procedure

Secondary Outcome Measures

Effectiveness of the procedure in terms of complete neoplasia resections [less than one month to get the pathology examination report]
Procedure is successful when the resection is complete with no residual tissue on the margins in depth and in the lateral part of the lesions.
Effectiveness of the procedure in terms of complete neoplasia resections [three month]
no macroscopic nor microscopic local recurrence during follow up endoscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

in the esophagus: squamous cell carcinoma (well differentiated G1) or high grade dysplasia or neoplasia on barrett esophagus with high grade dysplasia or adenocarcinoma confirmed by two different pathologists, with only superficial tissue (mucosal invasion (T1m) and no lymph nodes on EUS endoscopy radial and mini probe), larger than 15 mm of diameter, with an extension of less than 10 cm high and less than two thirds of the esophageal circumference
in the stomach: superficial adenocarcinoma or high grade dysplasia (well differentiated G1) with no depth invasion of the sub mucosa in EUS endoscopy and no lymph nodes according to the recommendations of the Japanese gastric cancer association, and with a diameter of more than 15 mm
in the colon and the rectum: sessile serrated adenomas, adenomas or superficial adenocarcinoma (well differentiated G1), larger than 15 mm, corresponding to non granular Lateral spreading tumor (NG-LST) or granular (G-LST) with a focal Kudo V zone in the lesion, with a circumferential extension of less than two thirds and with only a superficial extension (no sub mucosal invasion and no lymph nodes in EUS endoscopy of the rectum).
Consent form signed
Anesthesiology risk limited with ASA score 1 or 2
Patients over 18 years old
Affiliation to social safety system

Exclusion Criteria:

other lesions of the digestive tract
high anesthetic risk (ASA score > 2)
previous treatment of the lesion (radiotherapy, endoscopy, surgery, chemotherapy…)
other malignant disease locally advanced or with metastasis
hemostasis disorders
pregnancy or breast feeding
participation in another clinical trial