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Gastric endoscopic submucosal dissection under steady pressure automatically controlled endoscopy (SPACE); a multicenter randomized preclinical trial

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Abstract

Background

Steady pressure automatically controlled endoscopy (SPACE) is a new modality that eliminates on-demand insufflation but enables automatic insufflation in the gastrointestinal tract. Though its use in porcine esophageal ESD was reported to be promising, its applicability and potential effectiveness to gastric procedures have not been evaluated.

Objective

The aims were (1) to evaluate feasibility and safety of SPACE in the stomach, and (2) to assess its potential advantages over conventional endoscopy in preventing “blind insufflation”-related complications.

Design

A multicenter randomized preclinical animal study.

Setting

Laboratories at three universities.

Interventions

Experiment 1: Gastric ESD was attempted in the swine (n = 17), under either SPACE or manual insufflation. Experiment 2: Gastroscopy was performed for 10 min in the perforated stomach (n = 10) under either SPACE or manual insufflation.

Main outcome measurements

Experiment 1: ESD time, energy device activation time, number of forceps exchanges, specimen size, en block resection rate, vital signs and any intraoperative adverse events. Experiment 2: Intra-gastric and intra-abdominal pressures, vital signs, and any adverse events.

Results

Experiment 1: Gastric ESD was completed in all animals. ESD time tended to be shorter in SPACE than in the control, though the difference was not significant (p = 0.18). Experiment 2: Although both intra-gastric and intra-abdominal pressures remained within preset values in SPACE, they showed excessive elevation in control.

Limitations

An animal study with small sample size.

Conclusions

SPACE is feasible and safe for complicated and lengthy procedures such as gastric ESD, and is potentially effective in preventing serious consequences related to excessive blind insufflation.

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Abbreviations

CO2 :

Carbon dioxide

ESD:

Endoscopic submucosal dissection

SPACE:

Steady pressure automatically controlled endoscopy

ACS:

Abdominal compartment syndrome

EtCO2 :

End-tidal carbon dioxide

SpO2 :

Percutaneous oxygen saturation

References

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Funding

The co-author Kiyokazu Nakajima has received research funding from Top, Co., Ltd. (Tokyo, Japan) and Fujifilm Corp. (Tokyo, Japan).

Disclosures

Authors Takuya Yamada, Masashi Hirota, Shusaku Tsutsui, Motohiko Kato, Tsuyoshi Takahashi, Kazuhiro Yasuda, Kazuki Sumiyama, Masahiko Tsujii, Tetsuo Takehara, Masaki Mori, Yuichiro Doki and Kiyokazu Nakajima have no conflicts of interest or financial ties to disclose.

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Correspondence to Kiyokazu Nakajima.

Additional information

Takuya Yamada and Masashi Hirota have contributed equally to this study.

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Yamada, T., Hirota, M., Tsutsui, S. et al. Gastric endoscopic submucosal dissection under steady pressure automatically controlled endoscopy (SPACE); a multicenter randomized preclinical trial. Surg Endosc 29, 2748–2755 (2015). https://doi.org/10.1007/s00464-014-4001-0

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  • DOI: https://doi.org/10.1007/s00464-014-4001-0

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