Surgery: Splenectomy
ProcedureProcedure/Surgery: Surgery: Splenectomy
NCT Number: NCT00112099
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.
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Notify Me20 year–75 year
All sexes
Interventional
Phase 3
Aichi Cancer Center Hospital, Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Preoperatively
Intra-operatively
Exclusion criteria
Procedure/Surgery: Surgery: Splenectomy
Procedure/Surgery: Surgery: Spleen-preservation
Time frame: During the study conduct
Time frame: 5 years
Time frame: day of the operation
Time frame: 3 days after operation
Haruhiko Fukuda
Other
Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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