Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112099
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2005-05-27
Brief Title:
GCSSG-SPNX Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma JCOG0110
Sponsor:
Haruhiko Fukuda
Organization:
Japan Clinical Oncology Group
Study Overview
Official Title:
Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma JCOG0110
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Comparison Total gastrectomy with pancreas-preserving splenectomy versus total gastrectomy without splenectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C000000004 | None | None | None |