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

Phase 3

Completed

• Conditions: Gastric Neoplasm

• Registration Number: NCT00112099
• Lead Sponsor: Haruhiko Fukuda

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

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2005-05-27
• Study First Submitted QC: 2005-05-27
• Study First Posted: 2005-05-30
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival	During the study conduct

Secondary Outcome Measures

Name	Time	Method
operation time	day of the operation
Post-operative morbidity	5 years
perioperative blood loss	3 days after operation

Trial Locations

Locations (35)

Aichi Cancer Center Hospital; 🇯🇵 Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan

Fujita Health University; 🇯🇵 Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, 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, Hyogo, Japan

Iwate Medical University; 🇯🇵 Morioka,Uchimaru,19-1, Iwate, Japan

Kagoshima University,Faculty of Medicine; 🇯🇵 Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan

Kanagawa Cancer Center; 🇯🇵 Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan

Scroll for more (25 remaining)