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Sponsors and Collaborators: |
Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare |
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Information provided by: | Japan Clinical Oncology Group |
ClinicalTrials.gov Identifier: | NCT00112099 |
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.
Condition | Intervention | Phase |
---|---|---|
Gastric Neoplasm |
Procedure: Surgery: Splenectomy Procedure: Surgery: Spleen-preservation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110 |
Estimated Enrollment: | 500 |
Study Start Date: | June 2002 |
Estimated Study Completion Date: | July 2014 |
Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Procedure/Surgery: Surgery: Splenectomy
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Procedure: Surgery: Splenectomy
Procedure/Surgery: Surgery: Splenectomy
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2: Experimental
Procedure/Surgery: Surgery: Spleen-preservation
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Procedure: Surgery: Spleen-preservation
Procedure/Surgery: Surgery: Spleen-preservation
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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
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Preoperatively
Intra-operatively
Exclusion Criteria:
Contact: Takeshi Sano, MD, PhD | 81-3-3542-2511 | JCOG_sir@ml.jcog.jp |
Contact: Mitsuru Sasako, MD, PhD | 81-3-3542-2511 | JCOG_sir@ml.jcog.jp |
Study Chair: | Mitsuru Sasako, MD, PhD | Hyogo College of Medicine |
Responsible Party: | Japan Clinical Oncology Group ( Mitsuru Sasako, MD, PhD ) |
Study ID Numbers: | JCOG 0110, C000000004 |
Study First Received: | May 27, 2005 |
Last Updated: | February 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00112099 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
gastric neoplasm gastrectomy splenectomy randomized trial T2, T3 and T4 carcinoma in the proximal third of the stomach |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Stomach Neoplasms |
Gastrointestinal Neoplasms Stomach cancer Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |