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

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Abstract

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.

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Authors and Affiliations

  1. Gastroenterology and Endoscopy, Edouard Herriot Hospital, Lyon Cedex, France

    Mathieu Pioche, Vincent Lépilliez, Mihai Ciocîrlan, Jérôme Rivory, Clothilde Miaglia, Jean-Christophe Saurin & Thierry Ponchon

  2. Nestis, Lyon, France

    Mathieu Pioche

  3. LabTau, Inserm U1032, Lyon Cedex, France

    Mathieu Pioche & Thierry Ponchon

  4. Fundeni Gastroenterology Clinic, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania

    Mihai Ciocîrlan

  5. Pathology Department, Edouard Herriot Hospital, Lyon, France

    Valérie Hervieu

  6. Visceral Surgery Department, Edouard Herriot Hospital, Lyon Cedex, France

    Gilles Poncet

  7. Digestive Radiology Department, Edouard Herriot Hospital, Lyon Cedex, France

    Pierre-Jean Valette

Authors
  1. Mathieu Pioche
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  2. Vincent Lépilliez
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  3. Mihai Ciocîrlan
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  4. Jérôme Rivory
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  5. Clothilde Miaglia
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  6. Valérie Hervieu
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  7. Gilles Poncet
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  8. Pierre-Jean Valette
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  9. Jean-Christophe Saurin
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  10. Thierry Ponchon
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Corresponding author

Correspondence to Mathieu Pioche.

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Disclosures

Dr. Mathieu Pioche received a grant from Nestis outside of the present work. Dr. Vincent Lépilliez, Dr. Mihai Ciocirlan, Dr. Jérôme Rivory, Dr. Clothilde Miaglia, Dr. Valérie Hervieu, Pr. Gilles Poncet, Pr. Pierre Jean Valette, Pr. Jean-Christophe Saurin and Pr. Thierry Ponchon have nothing to declare.

Electronic supplementary material

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Exemple of lower GI procedure with the Nestis injector system (MP4 224636 kb)

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Pioche, M., Lépilliez, V., Ciocîrlan, M. et al. Endoscopic submucosal dissection with the Nestis® jet injector system with a bifunctional catheter: first prospective clinical trial (NCT: 2012-A00272-41). Surg Endosc 30, 5140–5146 (2016). https://doi.org/10.1007/s00464-016-4827-8

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  • DOI: https://doi.org/10.1007/s00464-016-4827-8

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