Clinical evaluation of schizophyllan adjuvant immunochemotherapy for patients with resectable gastric cancer —A randomized controlled trial—

1984 ◽  
Vol 14 (4) ◽  
pp. 286-292 ◽  
Author(s):  
Shigeru Fujimoto ◽  
Hisashi Furue ◽  
Tadashi Kimura ◽  
Tatsuhei Kondo ◽  
Kunzo Orita ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Clinical Evaluation ◽  
Controlled Trial ◽  
Adjuvant Immunochemotherapy ◽  
Randomized Controlled ◽  
Resectable Gastric Cancer

Long-term outcomes after prophylactic bursectomy in patients with resectable gastric cancer: Final analysis of a multicenter randomized controlled trial

Surgery ◽  
2015 ◽  
Vol 157 (6) ◽  
pp. 1099-1105 ◽  
Author(s):  
Motohiro Hirao ◽  
Yukinori Kurokawa ◽  
Junya Fujita ◽  
Hiroshi Imamura ◽  
Yoshiyuki Fujiwara ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Final Analysis ◽  
Long Term Outcomes ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Resectable Gastric Cancer

Randomized controlled trial of omental bursectomy for resectable cT2-3 gastric cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 72-72 ◽  
Author(s):  
Y. Kurokawa ◽  
Y. Fujiwara ◽  
S. Takiguchi ◽  
J. Fujita ◽  
H. Imamura ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Interim Analysis ◽  
Statistical Power ◽  
Controlled Trial ◽  
Final Analysis ◽  
Morbidity Rate ◽  
Randomized Controlled ◽  
Resectable Gastric Cancer ◽  
Gastric Cancer Patients

72 Background: Omental bursectomy, a traditional surgical procedure to dissect the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon, has often been performed against resectable gastric cancer. We have conducted a multi- institutional randomized controlled trial to elucidate the safety and usefulness of this procedure. Methods: Patients with cT2 or cT3 gastric adenocarcinoma were intraoperatively randomized to radical gastrectomy plus D2 lymphadenectomy either with or without bursectomy. The primary endpoint was overall survival (OS). The planned sample size was 464, with an alpha error of 0.05 and statistical power of 80% to detect a 10% margin of non-inferiority for the non-bursectomy group. The first interim analysis was conducted on Sep 2008, and we decided the preliminary data release according to Korn's proposal (J Clin Oncol. 2005). Results: Between Jul 2002 and Jan 2007, a total of 210 patients were randomized to either the bursectomy group or the non-bursectomy group. Background characteristics were well balanced. Intraoperative blood loss was greater in the bursectomy group than in the non-bursectomy group (median, 475 mL vs. 350 mL, p=0.047), while other surgical factors did not vary significantly. The overall morbidity rate was 14%, the same between two groups. The hospital mortality rate was 0.95%; one patient per group. In the first interim analysis, the 3-year OS were 86% in bursectomy group and 79% in non-bursectomy group, and the hazard ratio was 1.55 (95% CI: 0.84-2.84). The non-bursectomy group had more patients with peritoneal recurrences than the bursectomy group (14% vs. 8%). Conclusions: Experienced surgeons could safely perform a D2 gastrectomy with an additional bursectomy. First interim analysis suggested the survival advantage of omental bursectomy for cT2-3 gastric cancer patients. Final analysis will be conducted in 2012. No significant financial relationships to disclose.

scholarly journals Survival benefit of bursectomy in patients with resectable gastric cancer: interim analysis results of a randomized controlled trial

2011 ◽  
Vol 15 (1) ◽  
pp. 42-48 ◽  
Author(s):  
Junya Fujita ◽  
Yukinori Kurokawa ◽  
Tomoyuki Sugimoto ◽  
Isao Miyashiro ◽  
Shohei Iijima ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Interim Analysis ◽  
Survival Benefit ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Resectable Gastric Cancer

scholarly journals Comparison of submucosal and subserosal approaches toward optimized indocyanine green tracer-guided laparoscopic lymphadenectomy for patients with gastric cancer (FUGES-019): a randomized controlled trial

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Qi-Yue Chen ◽  
Qing Zhong ◽  
Ping Li ◽  
Jian-Wei Xie ◽  
Zhi-Yu Liu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Lymph Node ◽  
Indocyanine Green ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Tertiary Teaching ◽  
Significant Difference ◽  
Resectable Gastric Cancer ◽  
Optimal Approach

Abstract Background Application of indocyanine green (ICG) fluorescence imaging is effective in guiding laparoscopic radical lymphadenectomy for gastric cancer. However, the optimal approach for indocyanine green injection is controversial. Therefore, the objective of this study was aimed to compare the efficacy and ICG injection between the preoperative submucosal and intraoperative subserosal approaches for lymph node (LN) tracing during laparoscopic gastrectomy. Method This randomized controlled trial (ClinicalTrials.gov, NCT04219332) included 266 patients with potentially resectable gastric cancer (cT1–T4a, N0/+, M0) enrolled from a tertiary teaching center between December 2019 and October 2020. The primary endpoint was total number of retrieved LNs. Results In total, 259 patients (n = 130 and n = 129 in the submucosal and subserosal groups, respectively) were included in the per-protocol analysis. There are no significant differences in total number of retrieved LNs between the two groups (49.8 vs. 49.2, P = 0.713). The rate of LN noncompliance in the submucosal group was comparable to that in the subserosal group (32.3% vs. 33.3%, P = 0.860). No significant difference was found between the submucosal and subserosal groups in terms of the incidence (17.7% vs. 16.3%; P = 0.762) or severity of postoperative complications. The mean fluorescence cost in the submucosal group was higher than that in the subserosal group ($335.3 vs. $182.4; P < 0.001). The overall treatment satisfaction score was lower in the submucosal group than in the subserosal group (70.5 vs. 76.1%, P = 0.048). Conclusion ICG administered by subserosal injection was comparable to that administered by submucosal injection for lymph node tracing in gastric cancer. However, the former approach imposed a lower economic and mental burden on patients undergoing laparoscopic D2 lymphadenectomy. Trial registration ClinicalTrials.gov, NCT04219332.

scholarly journals Determination of Prognostic Factors in Japanese Patients With Advanced Gastric Cancer Using the Data From a Randomized Controlled Trial, Japan Clinical Oncology Group 9912

2014 ◽  
Vol 19 (4) ◽  
pp. 358-366 ◽  
Author(s):  
Daisuke Takahari ◽  
Narikazu Boku ◽  
Junki Mizusawa ◽  
Atsuo Takashima ◽  
Yasuhide Yamada ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Prognostic Factors ◽  
Advanced Gastric Cancer ◽  
Controlled Trial ◽  
Japanese Patients ◽  
Oncology Group ◽  
Japan Clinical Oncology Group ◽  
Randomized Controlled
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