Clinical trial NCT01913223: Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial
Official title: Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Intestinal Dysplasia
Esophageal Dysplasia
Colorectal Neoplasms
Keywords: Endoscopic submucosal dissection
jet injector
saline solution
safety
effectiveness
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety outcome
timeFrame: At 1 month
Secondary outcomes:
measure: Effectiveness of the procedure in terms of complete neoplasia resections
timeFrame: less than one month to get the pathology examination report
measure: Effectiveness of the procedure in terms of complete neoplasia resections
timeFrame: three month
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
Study officials:
References:
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.