GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00112099 |
Recruitment Status :
Completed
First Posted : May 30, 2005
Last Update Posted : September 22, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Neoplasm | Procedure: Surgery: Splenectomy Procedure: Surgery: Spleen-preservation | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110 |
Study Start Date : | June 2002 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Procedure/Surgery: Surgery: Splenectomy
|
Procedure: Surgery: Splenectomy
Procedure/Surgery: Surgery: Splenectomy |
Experimental: 2
Procedure/Surgery: Surgery: Spleen-preservation
|
Procedure: Surgery: Spleen-preservation
Procedure/Surgery: Surgery: Spleen-preservation |
- Overall survival [ Time Frame: During the study conduct ]
- Post-operative morbidity [ Time Frame: 5 years ]
- operation time [ Time Frame: day of the operation ]
- perioperative blood loss [ Time Frame: 3 days after operation ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112099

Study Chair: | Mitsuru Sasako, MD, PhD | Hyogo College of Medicine |
Publications:
Responsible Party: | Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group |
ClinicalTrials.gov Identifier: | NCT00112099 |
Other Study ID Numbers: |
JCOG 0110 C000000004 |
First Posted: | May 30, 2005 Key Record Dates |
Last Update Posted: | September 22, 2016 |
Last Verified: | September 2016 |
gastric neoplasm gastrectomy splenectomy randomized trial T2, T3 and T4 carcinoma in the proximal third of the stomach |
Carcinoma Stomach Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |