GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
- Conditions
- Gastric Neoplasm
- Registration Number
- NCT00112099
- Lead Sponsor
- Haruhiko Fukuda
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Preoperatively
- Histologically proven adenocarcinoma
- T2 or deeper lesion in the upper third of the stomach without involvement of the greater curvature or esophageal invasion, irrespective of the primary tumor location or existence of multiple foci
- No distant metastasis, not linitis plastica ('Borrmann 4'), not stump carcinoma, no prior treatment for 364 Randomized trial for splenectomy gastric cancer
- Sufficient organ function
- Written informed consent.
Intra-operatively
- T2/T3/T4 and N0/N1/N2, no tumor on the greater curvature, no direct invasion of the pancreas or spleen, negative peritoneal lavage cytology
- No apparent nodal metastasis in the splenic hilum or along the splenic artery
- Liver cirrhosis or portal hypertension
- Idiopathic thrombocytopenic purpura
- Severe pulmonary dysfunction
- Synchronous or metachronous (within 5 years) malignancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall survival During the study conduct
- Secondary Outcome Measures
Name Time Method Post-operative morbidity 5 years perioperative blood loss 3 days after operation operation time day of the operation
Trial Locations
- Locations (35)
Aichi Cancer Center Hospital
🇯🇵Nagoya,Chikusa-ku,Kanokoden,1-1, 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
Kyoto Second Red Cross Hospital
🇯🇵Kyoto,Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, 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
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
Kinki University School of Medicine
🇯🇵Osaka-Sayama,Ohno-higashi,377-2, Osaka, 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
Sakai Municipal Hospital
🇯🇵Sakai,Minamiyasuicho,1-1-1, Osaka, Japan
Osaka Medical College
🇯🇵Takatsuki,Daigakucho,2-7, Osaka, Japan
Saitama Cancer Center
🇯🇵Kita-adachi,Ina,Komuro,818, Saitama, Japan
Toyonaka Municipal Hospital
🇯🇵Toyonaka,Shibaharacho,4-14-1, Osaka, Japan
Shizuoka General Hospital
🇯🇵Shizuoka,Aoi-ku,Kitaando,4-27-1, Sizuoka, Japan
National Defense Medical College
🇯🇵Tokorozawa,Namiki,3-2, Saitama, Japan
Fujita Health University
🇯🇵Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan
Tokyo Metropolitan Komagome Hospital
🇯🇵Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
Toyama Prefectural Central Hospital
🇯🇵Toyama,Nishinagae,2-2-78, Toyama, Japan
Tokyo Metropolitan Bokutoh Hospital
🇯🇵Sumida-ku,Koutoubashi,4-23-15, Tokyo, Japan
International Medical Center of Japan
🇯🇵Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan
Cancer Institute Hospital
🇯🇵Koto-ku,Ariake,3-10-6, Tokyo, Japan
Wakayama Medical University, School of Medicine
🇯🇵Wakayama,Kimiidera,811-1, Wakayama, Japan
Yamagata Prefectural Central Hospital
🇯🇵Yamagata,Aoyagi,1800, Yamagata, Japan
Tokyo Medical and Dental University Hospital
🇯🇵Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan