Hitoshi Katai1, Junki Mizusawa2, Hiroshi Katayama2, Chikara Kunisaki3, Shinichi Sakuramoto4, Noriyuki Inaki5, Takahiro Kinoshita6, Yoshiaki Iwasaki7, Kazunari Misawa8, Nobuhiro Takiguchi9, Masahide Kaji10, Hiroshi Okitsu11, Takaki Yoshikawa12, Masanori Terashima13. 1. Department of Gastric Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji, chuo-ku, Tokyo, 104-0045, Japan. hkatai@ncc.go.jp. 2. Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan. 3. Department of Surgery, Yokohama City University, Yokohama, Japan. 4. Department of Gastroenterological Surgery, Saitama Medical University International Medical Center, Hidaka, Japan. 5. Department of Gastroenterological Surgery, Ishikawa Prefectural Central Hospital, Kanazawa, Japan. 6. Department of Gastric Surgery, National Cancer Center Hospital East, Kashiwa, Japan. 7. Department of Surgery, IMS Tokyo-Katsushika General Hospital, Tokyo, Japan. 8. Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan. 9. Department of Gastroenterological Surgery, Chiba Cancer Center, Chiba, Japan. 10. Department of Surgery, Toyama Prefectural Central Hospital, Toyama, Japan. 11. Department of Surgery, Tokushima Red Cross Hospital, Komatsushima, Japan. 12. Department of Gastric Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji, chuo-ku, Tokyo, 104-0045, Japan. 13. Division of Gastric Surgery, Shizuoka Cancer Center, Nagaizumi, Japan.
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.
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.
Entities:
Keywords:
Clinical trial; Gastrectomy; Gastric cancer; Laparoscopic surgery
Authors: Leonie Haverkamp; Teus J Weijs; Pieter C van der Sluis; Ingeborg van der Tweel; Jelle P Ruurda; Richard van Hillegersberg Journal: Surg Endosc Date: 2012-12-14 Impact factor: 4.584
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