Animal feasibility study of an innovated splash-needle for endoscopic submucosal dissection in the upper gastrointestinal tract

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Abstract

Background and aim

The high frequency of complications accompanying endoscopic submucosal dissection (ESD) and its complex processes suggest that the process requires improvement. The objective of the present study was to investigate the feasibility of an innovated splash-needle for ESD.

Methods

An animal feasibility study with a living pig was conducted. Six resections per portion (esophagus and upper, middle, and lower thirds of the stomach) in a total of 24 resections were carried out by using an original splash-needle or an innovated splash-needle. Major innovations were a thicker part in the middle of the knife and a metal plate on the tip of the sheath to obtain more coagulation ability. Injection solution in the submucosal layer was also changed due to possible influence on the outcomes. Main outcome measurements were entire procedure time, cutting speed, and frequency of bleeding during ESD.

Results

All the 24 resections were completed without complications. Among the obtained data, only mean cutting speeds were significantly influenced by location of the simulated lesion, which revealed that ESD at the upper third was significantly quicker than that at the lower third (P = 0.01), and ESD at the esophagus was significantly slower than that at the three parts of the stomach (P < 0.01). There was no significant difference between the different knives in each variable.

Conclusions

The innovated splash-needle will be feasible for human use, although the safety and advantages in clinical settings must be elucidated by proper comparative studies with existing knives in humans.

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