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

Primary Purpose

Barrett's Esophagus, Intestinal Dysplasia, Esophageal Dysplasia

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Nestis® jet injector system with a bi-functional catheter

About this trial

This is an interventional treatment trial for Barrett's Esophagus focused on measuring Endoscopic submucosal dissection, jet injector, saline solution, safety, effectiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hôpital Edouard Herriot

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

submucosal dissection by dissector water jet

Arm Description

Outcomes

Primary Outcome Measures

Safety outcome

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

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

no macroscopic nor microscopic local recurrence during follow up endoscopy

Full Information

NCT ID

NCT01913223

First Posted

July 30, 2013

Last Updated

May 23, 2019

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT01913223

Brief Title

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

Acronym

NESTIS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Barrett's Esophagus, Intestinal Dysplasia, Esophageal Dysplasia, Colorectal Neoplasms

Keywords

Endoscopic submucosal dissection, jet injector, saline solution, safety, effectiveness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

submucosal dissection by dissector water jet

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Nestis® jet injector system with a bi-functional catheter

Primary Outcome Measure Information:

Title

Safety outcome

Description

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

Time Frame

At 1 month

Secondary Outcome Measure Information:

Title

Effectiveness of the procedure in terms of complete neoplasia resections

Description

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.

Time Frame

less than one month to get the pathology examination report

Title

Effectiveness of the procedure in terms of complete neoplasia resections

Description

no macroscopic nor microscopic local recurrence during follow up endoscopy

Time Frame

three month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Hôpital Edouard Herriot

City

Lyon

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

26944726

Citation

Pioche M, Lepilliez V, Ciocirlan M, Rivory J, Miaglia C, Hervieu V, Poncet G, Valette PJ, Saurin JC, Ponchon T. Endoscopic submucosal dissection with the Nestis(R) jet injector system with a bifunctional catheter: first prospective clinical trial (NCT: 2012-A00272-41). Surg Endosc. 2016 Nov;30(11):5140-5146. doi: 10.1007/s00464-016-4827-8. Epub 2016 Mar 4.

Results Reference

result

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

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