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

Civil Hospices of Lyon

Status

Completed

Conditions

Colorectal Neoplasms

Esophageal Dysplasia

Intestinal Dysplasia

Barrett's Esophagus

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01913223

2011.709

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No 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