This trial is active, not recruiting.

Condition gastric neoplasm
Treatments surgery: splenectomy, surgery: spleen-preservation
Phase phase 3
Sponsor Japan Clinical Oncology Group
Collaborator Ministry of Health, Labour and Welfare, Japan
Start date June 2002
End date March 2014
Trial size 500 participants
Trial identifier NCT00112099, C000000004, JCOG 0110


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Procedure/Surgery: Surgery: Splenectomy
surgery: splenectomy
Procedure/Surgery: Surgery: Splenectomy
Procedure/Surgery: Surgery: Spleen-preservation
surgery: spleen-preservation
Procedure/Surgery: Surgery: Spleen-preservation

Primary Outcomes

Overall survival
time frame: During the study conduct

Secondary Outcomes

Post-operative morbidity
time frame: 5 years
operation time
time frame: day of the operation
perioperative blood loss
time frame: 3 days after operation

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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.

Additional Information

Official title Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by Japan Clinical Oncology Group.