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 |
|---|---|
| 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 |
|---|---|
| Secondary Outcome | relapse-free survival, post-operative morbidity, operation time and perioperative blood loss |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| 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) |
|---|---|
| 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 |