Journal Article

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

Kinoshita, Takahiro, Katayama, Hiroshi, Sakuramoto, Shinichi, Kaji, Masahide, Terashima, Masanori, Katai, Hitoshi, Kunisaki, Chikara, Iwasaki, Yoshiaki, Misawa, Kazunari, Takiguchi, Nobuhiro, Inaki, Noriyuki, Yoshikawa, Takaki, Okitsu, Hiroshi, Mizusawa, Junki

2019

Overview

BackgroundsLaparoscopy-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.MethodsThe 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%.ResultsBetween 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.ConclusionsThis 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.

• Publisher: Springer Nature B.V
• Subject: Anastomotic leak / Angina pectoris / Cancer therapies / Chemotherapy / Classification / Dissection / Endoscopy / Fistulae / Gastrectomy / Gastric cancer / Gastrointestinal surgery / Laparoscopy / Leakage / Oncology / Pancreas / Peer review / Safety / Surgeons / Surgical anastomosis