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.

Condition	Treatment or Intervention	Phase
Gastric Neoplasm	Procedure: Surgery: Splenectomy  Procedure: Surgery: Spleen-preservation	Phase III

Further Study Details: 

Primary Outcomes: Overall survival
Secondary Outcomes: Post-operative morbidity; operation time; perioperative blood loss
Expected Total Enrollment:  500

Ages Eligible for Study:  20 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Liver cirrhosis or portal hypertension
• Idiopathic thrombocytopenic purpura
• Severe pulmonary dysfunction
• Synchronous or metachronous (within 5 years) malignancy.

Please refer to this study by ClinicalTrials.gov identifier  NCT00112099

Takeshi Sano, MD, PhD      81-3-3542-2511    webmaster@ml.jcog.jp
Mitsuru Sasako, MD, PhD      81-3-3542-2511    webmaster@ml.jcog.jp

Japan, Tokyo
      National Cancer Center Hospital, 5-1-1,Tsukiji,Chuo-ku,  Tokyo,  104-0045,  Japan; Recruiting

Study chairs or principal investigators

Mitsuru Sasako, MD, PhD,  Study Chair,  National Cancer Center Hospital   

Study ID Numbers:  JCOG 0110
Record last reviewed:  March 2005
Last Updated:  May 27, 2005
Record first received:  May 27, 2005
ClinicalTrials.gov Identifier:  NCT00112099
Health Authority: Japan: Ministry of Health, Labor and Welfare (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-31