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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| submucosal dissection by dissector water jet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nestis® jet injector system with a bi-functional catheter | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Effectiveness of the procedure in terms of complete neoplasia resections |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot | Lyon | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26944726 | Result | 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. |
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no macroscopic nor microscopic local recurrence during follow up endoscopy |
| three month |
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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