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A Multi-institutional, Prospective, Phase II Feasibility Study of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Locally Advanced Gastric Cancer (JLSSG0901)

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Abstract

Background

The efficacy and safety outcomes of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection for locally advanced gastric cancer remain unclear. Therefore, we conducted a randomized, controlled phase II trial to confirm the feasibility of LADG in terms of technical safety, and short-term surgical outcomes were investigated.

Methods

Eligibility criteria included pre-operatively diagnosed advanced gastric cancer that could be treated by distal gastrectomy with D2 lymph node dissection; MP, SS, and SE without involvement of other organs; and N0–2 and M0. Patients aged 20–80 years were pre-operatively randomized.

Results

In total, 180 patients were registered and randomized to the open (89 patients) and laparoscopic arms (91 patients). Among 91 patients in the laparoscopic arm, 86 underwent laparoscopic gastrectomy according to the study protocol. Regarding the primary endpoint of the phase II trial, the proportion of patients with either anastomotic leakage or pancreatic fistula was 4.7 % (4/86). The grade 3 or higher morbidity rate, including systemic and local complications, was 5.8 %. Conversion to open surgery was required for 1 patient (1.2 %), without any intra-operative complication. The post-operative mortality rate was 0, and no patient required readmission for surgical complications within 6 months after initial discharge.

Conclusions

The technical safety of LADG with D2 lymph node dissection for locally advanced gastric cancer was demonstrated. A phase III trial to confirm the non-inferiority of this procedure to open gastrectomy in terms of long-term outcomes is ongoing. Registered Number: UMIN 000003420 (www.umin.ac.jp/ctr/).

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Acknowledgments

The following institutions participated in the study: Hakodate Goryokaku Hospital, Iwate Medical University, Saitama Medical University International Medical Center, Surugadai Nihon University Hospital, Tokyo Medical and Dental University, Keio University, St. Marianna University, Kitasato University East Hospital, Yokohama City University Medical Center, Saiseikai Takaoka Hospital, Fukui-ken Saiseikai Hospital, Ishikawa Prefectural Central Hospital, Nagano Municipal Hospital, Gifu University, Aichi Cancer Center Hospital, Nagoya University, Osaka General Medical Center, Osaka Medical College, Osaka University, Kinki University, Izumiotsu Municipal Hospital, Hyogo Cancer Center, Okayama University, Ehime University, Fukuoka University, Kyushu University, Saga University, and Oita University. This work is supported in part by the grant from the Japanese Foundation for Research and Promotion of Endoscopy.

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Authors and Affiliations

  1. Department of Gastroenterological Surgery, Ishikawa Prefectural Central Hospital, Kanazawa, Japan

    Noriyuki Inaki

  2. Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Hasama-machi, Oita, 879-5593, Japan

    Tsuyoshi Etoh

  3. Department of Mathematics and Statistics, Oita University Faculty of Medicine, Oita, Japan

    Tetsuji Ohyama

  4. Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki, Japan

    Kazuhisa Uchiyama

  5. Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan

    Natsuya Katada

  6. Department of Surgery, Iwate Medical University School of Medicine, Morioka, Japan

    Keisuke Koeda

  7. Department of Surgical Oncology, Gifu University, Gifu, Japan

    Kazuhiro Yoshida

  8. Department of Surgery, Hakodate Goryoukaku Hospital, Hakodate, Japan

    Akinori Takagane

  9. Center for Minimally Invasive Surgery, Tokyo Medical and Dental University, Bunkyō, Japan

    Kazuyuki Kojima

  10. Department of Gastroenterological Surgery, Comprehensive Cancer Center, Saitama International Medical Center, Saitama Medical University, Saitama, Japan

    Shinichi Sakuramoto

  11. Center for Community Medicine, Oita University Faculty of Medicine, Oita, Japan

    Norio Shiraishi

  12. Oita University, Oita, Japan

    Seigo Kitano

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  1. Noriyuki Inaki
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  2. Tsuyoshi Etoh
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  9. Kazuyuki Kojima
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  12. Seigo Kitano
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Corresponding author

Correspondence to Tsuyoshi Etoh.

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On behalf of the Japanese Laparoscopic Surgery Study Group.

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Inaki, N., Etoh, T., Ohyama, T. et al. A Multi-institutional, Prospective, Phase II Feasibility Study of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Locally Advanced Gastric Cancer (JLSSG0901). World J Surg 39, 2734–2741 (2015). https://doi.org/10.1007/s00268-015-3160-z

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