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Gastric Cancer

, Volume 22, Issue 5, pp 999–1008 | Cite as

Single-arm confirmatory trial of laparoscopy-assisted total or proximal gastrectomy with nodal dissection for clinical stage I gastric cancer: Japan Clinical Oncology Group study JCOG1401

  • Hitoshi KataiEmail author
  • Junki Mizusawa
  • Hiroshi Katayama
  • Chikara Kunisaki
  • Shinichi Sakuramoto
  • Noriyuki Inaki
  • Takahiro Kinoshita
  • Yoshiaki Iwasaki
  • Kazunari Misawa
  • Nobuhiro Takiguchi
  • Masahide Kaji
  • Hiroshi Okitsu
  • Takaki Yoshikawa
  • Masanori Terashima
  • On behalf of the Stomach Cancer Study Group of Japan Clinical Oncology Group
Original Article
  • 378 Downloads

Abstract

Backgrounds

Laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer is safe and feasible. In contrast, no prospective study evaluating the safety and efficacy of laparoscopy-assisted total gastrectomy (LATG) or laparoscopy-assisted proximal gastrectomy (LAPG) has been completed. We conducted a single-arm confirmatory trial to evaluate the safety of LATG/LAPG for clinical stage I (T1N0/T1N1/T2N0) proximal gastric cancer.

Methods

The extent of lymphadenectomy was selected based on the Japanese Gastric Cancer Treatment Guidelines. The mini-laparotomy incision was required to be ≤ 6 cm. The primary endpoint was the proportion of grade 2–4 (CTCAE ver. 4.0) esophagojejunal anastomotic leakage. The planned sample size was 245 considering a threshold of 8% and one-sided alpha of 2.5%.

Results

Between April 2015 and February 2017, 244 eligible patients were enrolled. LATG/LAPG was performed in 195/49. The proportion of conversions was 1.7%. Clinical T1N0/T1N1/T2N0 was 212/9/23. The extents of lymphadenectomy were as follows: D1+: 229; D2: 15. The median operation time was 309 min (IQR 265–353). The median blood loss was 30 ml (IQR 10–86). Grade 2–4 esophagojejunal anastomotic leakage was 2.5% (6/244; 95% CI 0.9–5.3). The overall proportion of in-hospital grade 3–4 adverse events was 29% (71/244). The proportions of intraabdominal abscess and pancreatic fistula were 3.7% and 2.0%, respectively. There were no treatment-related deaths.

Conclusions

This trial confirmed the safety of LATG/LAPG. After the non-inferiority of LADG is confirmed in our phase III trial (JCOG0912), LATG/LAPG is expected to be established as one of the standard treatments for clinical stage I gastric cancer.

Keywords

Gastric cancer Laparoscopic surgery Gastrectomy Clinical trial 

Notes

Funding

The study was supported in part by the National Cancer Center Research and Development Funds (26-A-4, 29-A-3), Grant-in-Aid for Clinical Cancer Research H26-053, and AMED under Grant numbers JP18ck0106317, JP15ck0106056.

Compliance with ethical standards

Conflict of interest

We certify that we have no conflicts of interests to declare.

Human rights statement

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions.

Informed consent

Informed consent was obtained from all patients included in the study.

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Copyright information

© The International Gastric Cancer Association and The Japanese Gastric Cancer Association 2019

Authors and Affiliations

  • Hitoshi Katai
    • 1
    Email author
  • Junki Mizusawa
    • 2
  • Hiroshi Katayama
    • 2
  • Chikara Kunisaki
    • 3
  • Shinichi Sakuramoto
    • 4
  • Noriyuki Inaki
    • 5
  • Takahiro Kinoshita
    • 6
  • Yoshiaki Iwasaki
    • 7
  • Kazunari Misawa
    • 8
  • Nobuhiro Takiguchi
    • 9
  • Masahide Kaji
    • 10
  • Hiroshi Okitsu
    • 11
  • Takaki Yoshikawa
    • 1
  • Masanori Terashima
    • 12
  • On behalf of the Stomach Cancer Study Group of Japan Clinical Oncology Group
  1. 1.Department of Gastric SurgeryNational Cancer Center HospitalTokyoJapan
  2. 2.Japan Clinical Oncology Group Data Center/Operations OfficeNational Cancer Center HospitalTokyoJapan
  3. 3.Department of SurgeryYokohama City UniversityYokohamaJapan
  4. 4.Department of Gastroenterological SurgerySaitama Medical University International Medical CenterHidakaJapan
  5. 5.Department of Gastroenterological SurgeryIshikawa Prefectural Central HospitalKanazawaJapan
  6. 6.Department of Gastric SurgeryNational Cancer Center Hospital EastKashiwaJapan
  7. 7.Department of SurgeryIMS Tokyo-Katsushika General HospitalTokyoJapan
  8. 8.Department of Gastroenterological SurgeryAichi Cancer Center HospitalNagoyaJapan
  9. 9.Department of Gastroenterological SurgeryChiba Cancer CenterChibaJapan
  10. 10.Department of SurgeryToyama Prefectural Central HospitalToyamaJapan
  11. 11.Department of SurgeryTokushima Red Cross HospitalKomatsushimaJapan
  12. 12.Division of Gastric SurgeryShizuoka Cancer CenterNagaizumiJapan

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