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

BACKGROUND

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.

METHODS

A prospective study including 18 patients with esophageal, gastric and rectal superficial neoplasms treated by ESD using Enki-2 was designed.

RESULTS

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).

CONCLUSIONS

ESD with Enki-2 water jet system is effective and safe for superficial neoplastic digestive lesions.