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Late phase II study of robot-assisted gastrectomy with nodal dissection for clinical stage I gastric cancer

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Abstract

Background

The feasibility of robot-assisted gastrectomy (RG) in terms of safety is unclear due to a lack of prospective studies. We showed feasible surgical outcomes in our previous study. In this phase II study, we assessed feasibility of the procedure by recruiting a larger number of patients.

Method

This single-center, prospective phase II study included patients with clinical stage I gastric cancer undergoing RG. The primary end point was the incidence of postoperative intra-abdominal infectious complications, including anastomotic leakage, pancreas-related infection, and intra-abdominal abscess. The secondary end points were overall survival, relapse-free survival, RG completion rate, and incidence of all surgical morbidities.

Results

A total of 120 patients were recruited between December 2012 and April 2015. The incidence of intra-abdominal infectious complications was 3.3 % (95 % CI 0.9–8.3 %), and all complications were successfully treated conservatively without re-operation. The incidence of overall adverse events was 14.2 % (95 % CI 8.5–21.7 %). Three patients required conversion to open gastrectomy according to the protocol due to advancement of disease.

Conclusion

Our data show that RG is safe in terms of the incidence and severity of postoperative complications.

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Acknowledgments

This research was partially supported by the National Cancer Center Research and Development Fund (26-A-4) and Practical Research for Innovative Cancer Control (#201438039A) from the Japan Agency for Medical Research and Development.

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Authors and Affiliations

  1. Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan

    Masanori Tokunaga, Rie Makuuchi, Yuiciro Miki, Yutaka Tanizawa, Etsuro Bando, Taiichi Kawamura & Masanori Terashima

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  1. Masanori Tokunaga
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  2. Rie Makuuchi
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  3. Yuiciro Miki
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  4. Yutaka Tanizawa
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  6. Taiichi Kawamura
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  7. Masanori Terashima
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Correspondence to Masanori Tokunaga.

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Disclosures

Tokunaga, Makuuchi, Miki, Tanizawa, Bando, Kawamura, Terashima have no conflict of interest or financial ties to disclose.

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Tokunaga, M., Makuuchi, R., Miki, Y. et al. Late phase II study of robot-assisted gastrectomy with nodal dissection for clinical stage I gastric cancer. Surg Endosc 30, 3362–3367 (2016). https://doi.org/10.1007/s00464-015-4613-z

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  • DOI: https://doi.org/10.1007/s00464-015-4613-z

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