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/).
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.
We have developed a combined laparoscopic and luminal endoscopic surgery technique for resection of gastric submucosal tumors (SMTs) that can be performed without excessive resection of the stomach. In a multicenter retrospective study we aimed to evaluate the feasibility and safety of laparoscopic and endoscopic cooperative surgery (LECS) for gastric SMT resection. Between October 2007 and December 2011, 126 patients with gastric SMTs underwent LECS at 8 institutions. Patient demographics, tumor histopathologic characteristics, and operative and follow-up data were reviewed.16 tumors (12.7 %) were located in the upper third of the stomach, 88 (69.8 %) in the middle third, 5 (4.0 %) in the lower third, and 17 (13.5 %) at the esophagogastric junction. The mean (standard deviation [SD]) operation time for LECS was 190.2 (66.8) min, with a mean estimated blood loss of 15.1 (38.6) mL. In 2 cases (1.6 %), the procedure was converted to open surgery because of intra-abdominal adhesions or stenosis. Morbidity was found in 6 cases (4.8 %), including 2 leakage, 2 gastric stasis, 1 fever, and 1 cystitis. Histologically, a gastrointestinal stromal tumor (GIST) was found in 86 (68.3 %) cases. The median follow-up period was 54.7 months; no local or distant tumor recurrence was observed and all patients were alive. LECS proved to be a safe and feasible procedure for the resection of gastric SMTs, with a reasonable operation time, low bleeding, and an acceptable complication rate in this multicenter study in Japan.
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