Gastric Neoplasm
Conditions
Keywords
gastric neoplasm, gastrectomy, splenectomy, randomized trial, T2, T3 and T4 carcinoma in the proximal third of the stomach
Brief summary
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.
Detailed 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
Interventions
PROCEDURESurgery: Splenectomy
Procedure/Surgery: Surgery: Splenectomy
PROCEDURESurgery: Spleen-preservation
Procedure/Surgery: Surgery: Spleen-preservation
Sponsors
Ministry of Health, Labour and Welfare, Japan
Haruhiko Fukuda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | During the study conduct |
Secondary
| Measure | Time frame |
|---|---|
| perioperative blood loss | 3 days after operation |
| Post-operative morbidity | 5 years |
| operation time | day of the operation |
Countries
Japan
Outcome results
None listed