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KMID : 0914820160160020093
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Journal of the Korean Gastric Cancer Association
2016 Volume.16 No. 2 p.93 ~ p.97
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Non-Randomized Confirmatory Trial of Laparoscopy-Assisted Total Gastrectomy and Proximal Gastrectomy with Nodal Dissection for Clinical Stage I Gastric Cancer: Japan Clinical Oncology Group Study JCOG1401
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Kozo Kataoka
Hitoshi Kata
Junki Mizusawa
Hiroshi Katayama
Kenichi Nakamura
Shinji Morita
Takaki Yoshikawa
Seiji Ito
Takahiro Kinoshita
Takeo Fukagawa
Mitsuru Sasako
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Abstract
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Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospective study evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japanese institutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints are overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assist-ed proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. The UMIN Clinical Trials Registry number is UMIN000017155.
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KEYWORD
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Laparoscopy, Gastrectomy, Nonrandomized clinical trial
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