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

Haruhiko Fukuda

Status and phase: Completed; Phase 3

Conditions: Gastric Neoplasm

Treatments: Procedure: Surgery: Splenectomy; Procedure: Surgery: Spleen-preservation

Study type: Interventional

Funder types: Other

Identifiers

NCT00112099

JCOG 0110

C000000004

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

1

Active Comparator group

Description:

Procedure/Surgery: Surgery: Splenectomy

Treatment:

Procedure: Surgery: Splenectomy

2

Experimental group

Description:

Procedure/Surgery: Surgery: Spleen-preservation

Treatment:

Procedure: Surgery: Spleen-preservation