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

Colorectal Neoplasms Clinical Trial

— NESTIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913223
• Other study ID #: 2011.709
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Pioche M, Lépilliez V, Ciocîrlan M, Rivory J, Miaglia C, Hervieu V, Poncet G, Valette PJ, Saurin JC, Ponchon T. Endoscopic submucosal dissection with the Nestis(®) jet injector system with a bifunctional catheter: first prospective clinical trial (NCT: 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At 1 month
Secondary	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.	less than one month to get the pathology examination report
Secondary	Effectiveness of the procedure in terms of complete neoplasia resections	no macroscopic nor microscopic local recurrence during follow up endoscopy	three month