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

Phase 3
20 Years
75 Years
Open (Enrolling)
Gastric Neoplasm

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Trial Information

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

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

Inclusion Criteria:


- 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.


- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

During the study conduct

Safety Issue:


Principal Investigator

Mitsuru Sasako, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hyogo College of Medicine


Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG 0110



Start Date:

June 2002

Completion Date:

March 2014

Related Keywords:

  • Gastric Neoplasm
  • gastric neoplasm
  • gastrectomy
  • splenectomy
  • randomized trial
  • T2, T3 and T4 carcinoma in the proximal third of the stomach
  • Neoplasms
  • Carcinoma
  • Stomach Neoplasms