UMIN ID: C000000004
Registered date:07/06/2005
Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma(JCOG0110, GCSSG-SPNX)
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | T2, T3, and T4 carcinoma in the proximal third of the stomach |
Date of first enrollment | 2002/06/01 |
Target sample size | 500 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | A:Surgery:splenectomy B:Surgery:spleen-preservation |
Outcome(s)
Primary Outcome | overall survival |
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Secondary Outcome | relapse-free survival, post-operative morbidity, operation time and perioperative blood loss |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 75years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | (1) Liver cirrhosis or portal hypertension (2) idiopathic thrombocytopenic purpura (3) severe pulmonary dysfunction (4)synchronous or metachronous (within 5 years) malignancy |
Related Information
Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
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Secondary Sponsor | |
Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
Secondary ID(s) | NCT00112099 |
Contact
public contact | |
Name | Takeshi Sano, MD, PhD |
Address | 3-10-6, Ariake, Koto-ku, Tokyo, 135-8550, JAPAN Japan |
Telephone | 03-3520-0111 |
JCOG_sir@ml.jcog.jp | |
Affiliation | JCOG0110 Coordinating Office Gastroenterological Surgery, Cancer Institute Hospital |
scientific contact | |
Name | Mitsuru Sasako, MD, PhD |
Address | 1-1 Mukogawacho, Nishinomiya, Hyogo, Japan Japan |
Telephone | 0798-45-6767 |
msasako@hyo-med.ac.jp | |
Affiliation | Hyogo College of Medicine Upper GI Surgery Division |