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

Phase 3CompletedNCT00112099

Haruhiko Fukuda500 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Gastric Neoplasm

Interventions

Surgery: SplenectomyPROCEDURE

Procedure/Surgery: Surgery: Splenectomy

Surgery: Spleen-preservationPROCEDURE

Procedure/Surgery: Surgery: Spleen-preservation

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (35)

Outcomes

Primary Outcomes

Overall survival

Time frame: During the study conduct

Secondary Outcomes

Post-operative morbidity

Time frame: 5 years

operation time

Time frame: day of the operation

perioperative blood loss

Time frame: 3 days after operation

Data from ClinicalTrials.gov

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Aichi Cancer Center Hospital

Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan

Fujita Health University

Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, Japan

Gifu Municipal Hospital

Gifu,Kashima-cho,7-1, Gifu, Japan

Hiroshima City Hospital

Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan

Itami City Hospital

Itami,Koyaike,1-100, Hyōgo, Japan

Iwate Medical University

Morioka,Uchimaru,19-1, Iwate, Japan

Kagoshima University,Faculty of Medicine

Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, Japan

Kanagawa Cancer Center

Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan

...and 25 more locations