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Brief Title: GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Official Title: Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Study ID: NCT00112099
Brief Summary: The purpose of this study is to evaluate the role of splenectomy in potentially curative total gastrectomy for proximal gastric carcinoma in terms of survival benefit and post-operative morbidity.
Detailed Description: European clinical trials of gastrectomy showed that splenectomy is an important risk factor for post-operative morbidity and mortality. Retrospective comparisons suggested that splenectomy is associated with poor long term survival. However, Japanese studies revealed that 20 - 30 % of patients with non-early carcinoma in the proximal stomach have nodal metastasis in the splenic hilum and therefore, pancreas-preserving splenectomy is part of the standard operation in specialized centers where splenectomy is not considered a risk factor for operative mortality. There have been no prospective randomized trials to evaluate the survival benefit of splenectomy in total gastrectomy for proximal gastric cancer. Comparison: Total gastrectomy with pancreas-preserving splenectomy versus total gastrectomy without splenectomy
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aichi Cancer Center Hospital, Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan
Fujita Health University, Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan
National Cancer Center Hospital East, Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama,Horinouchi,13, Ehime, Japan
Gifu Municipal Hospital, Gifu,Kashima-cho,7-1, Gifu, Japan
Hiroshima City Hospital, Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan
Itami City Hospital, Itami,Koyaike,1-100, Hyogo, Japan
Iwate Medical University, Morioka,Uchimaru,19-1, Iwate, Japan
Kagoshima University,Faculty of Medicine, Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan
Kanagawa Cancer Center, Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan
Kyoto Second Red Cross Hospital, Kyoto,Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, Japan
Miyagi Cancer Center, Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan
National Hospital Organization, Sendai Medical Center, Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, Japan
Nagaoka Chuo General Hospital, Nagaoka,Kawasaki,2041, Niigata, Japan
Niigata Cancer Center Hospital, Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Tsubame Rosai Hospital, Tsubame,Sawatari,633, Niigata, Japan
Oita University Fuculty of Medicine, Oita1-1,Hasama-machi,Oogaoka, Oita, Japan
Osaka National Hospital, Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan
Kinki University School of Medicine, Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan
Sakai Municipal Hospital, Sakai,Minamiyasuicho,1-1-1, Osaka, Japan
Osaka Medical College, Takatsuki,Daigakucho,2-7, Osaka, Japan
Toyonaka Municipal Hospital, Toyonaka,Shibaharacho,4-14-1, Osaka, Japan
Saitama Cancer Center, Kita-adachi,Ina,Komuro,818, Saitama, Japan
National Defense Medical College, Tokorozawa,Namiki,3-2, Saitama, Japan
Shizuoka General Hospital, Shizuoka,Aoi-ku,Kitaando,4-27-1, Sizuoka, Japan
Tokyo Metropolitan Komagome Hospital, Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan
Tokyo Medical and Dental University Hospital, Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan
National Cancer Center Hospital, Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
Cancer Institute Hospital, Koto-ku,Ariake,3-10-6, Tokyo, Japan
International Medical Center of Japan, Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital, Sumida-ku,Koutoubashi,4-23-15, Tokyo, Japan
Toyama Prefectural Central Hospital, Toyama,Nishinagae,2-2-78, Toyama, Japan
Wakayama Medical University, School of Medicine, Wakayama,Kimiidera,811-1, Wakayama, Japan
Yamagata Prefectural Central Hospital, Yamagata,Aoyagi,1800, Yamagata, Japan
Name: Mitsuru Sasako, MD, PhD
Affiliation: Hyogo Medical University
Role: STUDY_CHAIR