Endoscopic submucosal dissection with the Nestis® jet injector system with a bifunctional catheter: first prospective clinical trial (NCT: 2012-A00272-41)

Autor: Mihai Ciocirlan, Pierre-Jean Valette, Thierry Ponchon, Mathieu Pioche, Clothilde Miaglia, Jean-Christophe Saurin, Valérie Hervieu, Gilles Poncet, Vincent Lepilliez, Jérôme Rivory
Rok vydání: 2016
Předmět:
Zdroj: Surgical Endoscopy. 30:5140-5146
ISSN: 1432-2218
0930-2794
DOI: 10.1007/s00464-016-4827-8
Popis: The Enki-2 water jet system (Nestis SAS®, Lyon, France) with dual injection and dissection capability significantly reduced ESD procedure time and perforation rates in animal studies. The study aim was to evaluate its efficacy and safety in patients with superficial neoplastic lesions. A prospective study including 18 patients with esophageal, gastric and rectal superficial neoplasms treated by ESD using Enki-2 was designed. Eighteen lesions (6 esophageal, 3 gastric, 9 rectal, mean diameter 43.5 mm) in 17 patients (10 men, mean age 65.9) were included. The mean procedure time was 65.6 min. One patient needed clipping for an incomplete muscle tear during procedure; there were neither delayed bleedings nor perforation. The “en bloc” resection rate was 100 %, the R0 resection rate was 88.9 % (16/18 lesions), and the curative resection rate was 77.8 %. The 3-month disease-free rate was 92.3 % (12/13 patients, 13/14 lesions, 1 patient lost to follow-up). The 12-month disease-free rate was 69.2 % (9/13 patients, 10/14 lesions, 4 patients lost to follow-up). ESD with Enki-2 water jet system is effective and safe for superficial neoplastic digestive lesions.
Databáze: OpenAIRE
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