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Δευτέρα 27 Νοεμβρίου 2017

The Optimal Injection Solution for Endoscopic Submucosal Dissection: A Randomized Controlled Trial of Western Solutions in a Porcine Model

Abstract

Background

When performing endoscopic submucosal dissection (ESD), procedural safety increases with greater tissue elevation and efficiency increases with longer-lasting submucosal cushion. Fluids specifically developed for ESD in Asia aren't commercially available in the West, leading endoscopists to use a variety of injectable fluids off-label. To determine the optimal fluid available in the West, we compared commonly used fluids for Western ESD.

Methods

All phases were performed in an ex-vivo porcine stomach model. Phase-1 compared tissue elevation and duration of submucosal cushions produced by various standard volumes of various injectable solutions used for ESD. The two best performing solutions used off-label were tested head-to-head in ESD in Phase-2. Phase-3 compared the best solution from Phase-2 to Eleview®, currently the only submucosal injection fluid approved in the United States. In Phase-2 and 3, 5 ESDs were performed with each solution. The solutions were randomized and the endoscopist blinded to the solution.

Results

The best performing solutions in Phase 1 were 0.4% hyaluronic acid, 6% hydroxyethyl starch (HES), and Eleview®. Phase-2 compared 6% HES and hydroxypropyl methylcellulose (HPMC), demonstrating ESD with 6% HES was easier (p=0.007), faster (p=0.041) and required less injection volume (p=0.003). In Phase-3, resection speed, ease of ESD and total volume per area resected were comparable between 6% HES and Eleview®.

Conclusions

Of the submucosal injection fluids currently available in the West, Eleview® and 6% HES are the best-performing solutions for ESD in a porcine model.

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