GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110

Study Overview
=================
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

Official Title
-----------------
Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110

Conditions
-----------------
Gastric Neoplasm

Intervention / Treatment
-----------------
* Procedure: Surgery: Splenectomy
* Procedure: Surgery: Spleen-preservation


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Procedure/Surgery: Surgery: Splenectomy | Procedure: Surgery: Splenectomy<br>* Procedure/Surgery: Surgery: Splenectomy<br>|
| Experimental: 2<br>Procedure/Surgery: Surgery: Spleen-preservation | Procedure: Surgery: Spleen-preservation<br>* Procedure/Surgery: Surgery: Spleen-preservation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | During the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative morbidity |  | 5 years | 
| operation time |  | day of the operation | 
| perioperative blood loss |  | 3 days after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric neoplasm, gastrectomy, splenectomy, randomized trial, T2, T3 and T4 carcinoma in the proximal third of the stomach