J Gastric Cancer.  2016 Jun;16(2):93-97. 10.5230/jgc.2016.16.2.93.

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

• Kataoka K
• Katai H
• Mizusawa J
• Katayama H
• Nakamura K
• Morita S
• Yoshikawa
• Ito S
• Kinoshita
• Fukagawa T
• Sasako M
• Stomach Cancer Study Group/Japan Clinical Oncology Group

• KMID: 2328075
• DOI: http://doi.org/10.5230/jgc.2016.16.2.93

Abstract

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-assisted 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.

Keyword

Laparoscopy; Gastrectomy; Nonrandomized clinical trial

MeSH Terms

Anastomotic Leak
Asian Continental Ancestry Group
Conversion to Open Surgery
Gastrectomy*
Humans
Japan*
Laparoscopy
Medical Oncology*
Non-Randomized Controlled Trials as Topic
Prospective Studies
Stomach Neoplasms*

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