Gastric Neoplasm Clinical Trial
Official title:
Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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