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
- 378 Downloads
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.
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%.
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.
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.
KeywordsGastric cancer Laparoscopic surgery Gastrectomy Clinical trial
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 was obtained from all patients included in the study.
- 1.Katai H, Sasako M, Fukuda H, Nakamura K, Hiki N, Saka M, et al. Safety and feasibility of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer: a multicenter phase II trial (JCOG 0703). Gastric Cancer. 2010;13(4):238–44.CrossRefGoogle Scholar
- 3.Katai H, Mizusawa J, Katayama H, Takagi M, Yoshikawa T, Fukagawa T, et al. Short-term surgical outcomes from a phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer: Japan Clinical Oncology Group Study JCOG0912. Gastric Cancer. 2017;20(4):699–708.CrossRefGoogle Scholar
- 4.Kataoka K, Katai H, Mizusawa J, Katayama H, Nakamura K, Morita S, et al. Non-randomized confirmatory trial of laparoscopy-assisted total gastrectomy and proximal gastrectomy with nodal dissection for clinical stage I gastric cancer: Japan Clinical Oncology Group study JCOG1401. J Gastric Cancer. 2016;16(2):93–7.CrossRefGoogle Scholar
- 7.Institute NC. Common terminology criteria for adverse events (CTCAE) version 4.0. Bethesda: National Cancer Institute; 2015.Google Scholar
- 16.Etoh T, Honda M, Kumamaru H, Miyata H, Yoshida K, Kodera Y, et al. Morbidity and mortality from a propensity score-matched, prospective cohort study of laparoscopic versus open total gastrectomy for gastric cancer: data from a nationwide web-based database. Surg Endosc. 2018;32(6):2766–73.CrossRefGoogle Scholar
- 18.Katai H, Ishikawa T, Akazawa K, Isobe Y, Miyashiro I, Oda I, et al. Five-year survival analysis of surgically resected gastric cancer cases in Japan: a retrospective analysis of more than 100,000 patients from the nationwide registry of the Japanese Gastric Cancer Association (2001–2007). Gastric Cancer. 2018;21(1):144–54.CrossRefGoogle Scholar