Efficacy of an antiadhesive agent for the prevention of intra-abdominal adhesions after radical gastrectomy: A prospective randomized, multicenter trial.

BACKGROUND: Guardix-SG is a poloxamer-based antiadhesive agent. The aim of this study was to investigate its efficacy in preventing abdominal adhesions in gastric cancer patients undergoing gastrectomy. Few clinical studies have reported that antiadhesive agent reduces the incidence of adhesion after gastrectomy. METHODS: We conducted a multicenter trial from June 2013 and August 2015 in patients with gastric adenocarcinoma undergoing radical gastrectomy. Patients were randomly assigned to the Guardix treatment or control group. Postoperative adhesions were diagnosed based on postoperative symptoms, plain x-ray films, and computed tomography. The primary endpoint of the study was the incidence of small bowel obstruction in the first postoperative year. The secondary end-point was the safety of Guardix-SG. RESULTS: The study included 109 patients in the Guardix group and 105 patients in the control group. The groups were similarly matched with pathological stage, operation type, anastomosis method, midline incision length, and the extent of lymph node dissection. Eight in the Guardix group and 21 in the control group experienced intestinal obstruction during the 1-year follow-up period. The cumulative incidence of small bowel obstruction was significantly lower in the Guardix group compared to that seen in the control group (4.7% vs 8.6% at 6 months and 7.3% vs 20% at 1 year; P = .007, log-rank test). There were no differences in postoperative complications and adverse events. CONCLUSION: Guardix-SG significantly decreased the incidence of intestinal obstruction without affecting the incidence of postoperative complications.

Safety of laparoscopic radical gastrectomy in gastric cancer patients with liver cirrhosis.

BACKGROUND: Laparoscopic gastrectomy (LG) in gastric cancer patients with liver cirrhosis (LC) has rarely been reported. In this study, we aimed to elucidate the feasibility of LG compared with that of open gastrectomy (OG) for LC patients. METHODS: Of the 75 LC patients who underwent radical gastrectomy for gastric cancer between April 2005 and March 2014, 36 patients who underwent LG were compared with 39 patients who underwent OG. Comparisons were based on clinicopathologic characteristics, surgical outcomes, and long-term survival rates. RESULTS: Comparison of LG and OG revealed no significant differences in the clinicopathologic characteristics. Five patients in the LG group and eight in the OG group showed a Child-Turcotte-Pugh score (CTPs) over A. In surgical outcomes, we observed shorter operation times (191.4 ± 63.9 vs. 225.9 ± 77.1 min, p = 0.039), reduced estimated blood loss (175.5 ± 214.1 vs. 396.9 ± 514.8 ml, p = 0.021), and shorter hospital stays (10.4 ± 4.6 vs. 13.7 ± 5.8 days, p = 0.008) in LG than OG. Regarding postoperative morbidity, 7 (19.4%) and 10 (25.6%) complications were observed in the LG and OG groups, respectively. There was no difference in complications between the two groups regardless of the CTPs. One patient with a CTPs of C succumbed to hepatic failure following LG. Long-term survival and overall and recurrence-free survival rates did not differ between the two groups. CONCLUSIONS: Even in cases with CTPs B, LG with lymph node dissection for gastric cancer patient was safer and acceptable than OG was. Therefore, LG can be considered an alternative surgical approach in gastric cancer with LC.

Randomized, multicenter, phase III trial of heptaplatin 1-hour infusion and 5-fluorouracil combination chemotherapy comparing with cisplatin and 5-fluorouracil combination chemotherapy in patients with advanced gastric cancer.

PURPOSE: Heptaplatin (Sunpla) is a cisplatin derivative. A phase IIb trial using heptaplatin resulted in a 34% response rate with mild nephrotoxicity. We conducted a randomized phase III trial of heptaplatin plus 5-FU compared with cisplatin plus 5-FU in patients with advanced gastric cancer. MATERIALS AND METHODS: One hundred seventy-four patients (heptaplatin, n=88; cisplatin, n=86) from 13 centers were enrolled. The eligibility criteria were as follows: patients with pathologically-proven adenocarcinoma, chemonaive patients, or patients who had received only single adjuvant chemotherapy, and who had a measurable or evaluable lesion. On day 1, heptaplatin (400 mg/m(2)) or cisplatin (60 mg/m(2)) was given over 1 hour with 5-FU (1 gm/m(2)) on days 1~5 every 4 weeks. RESULTS: At the time of survival analysis, the median overall survival was 7.3 months in the 5-FU + heptaplatin (FH) arm and 7.9 months in the 5-FU + cisplatin (FP) arm (p=0.24). Of the FH patients, 34.2% (complete response [CR], 1.3%; partial response [PR], 32.9%) experienced a confirmed objective response compared with 35.9% (CR 0%, PR 35.9%) of FP patients (p=0.78). The median-time-to-progression was 2.5 months in the FH arm and 2.3 months in the FP arm. The incidence of neutropenia was higher with FP (28%) than with FH (16%; p=0.06); grade 3~4 nausea and vomiting were more frequent in the FP than in the FH arm (p=0.01 and p=0.05, respectively). The incidence of increased proteinuria and creatininemia was higher with FH than with FP; however, there was no statistical difference. There were no treatment-related deaths. CONCLUSION: Heptaplatin showed similar effects to cisplatin when combined with 5-FU in advanced gastric cancer patients with tolerable toxicities.