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This study is to conduct a randomized controlled trial of two kinds of radical gastrectomy for patients with proximal gastric cancer. One is laparoscopic D2 radical total gastrectomy combined with spleen-preserving No.10 lymph node dissection , another one is laparoscopic D2 radical total gastrectomy without clearing the No. 10 lymph nodes of the spleen. We explore the effect of the two procedures on the survival of patients, as well as the surgical complications associated with the two procedures, the number of lymph node dissection, the operation time and the amount of intraoperative blood loss. Furthermore, we also want to discuss the application value of laparoscopic lymph node dissection for spleen preservation in radical gastrectomy for proximal gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D2 Lymphadenectomy including No. 10 | Experimental | lymphadenectomy including spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group |
|
| D2 lymphadenectomy excluding No. 10 | Active Comparator | Laparoscopic total gastrectomy with D2 lymphadenectomy but without No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D2 Lymphadenectomy including No. 10 | Procedure | After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | The early postoperative complication are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th. | 30 days; 36 months |
| 3-year overall survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Suo, Ph.D. | Contact | 181 8687 1293 | suojian0066@126.com | |
| Yuchen Guo, Ph.D. | Contact | 13630598312 | guoyuchen8688@live.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Suo | Jilin University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
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|
| D2 lymphadenectomy excluding No. 10 | Procedure | After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy |
|
| 36 months |
| 3-year recurrence pattern | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type | 36 months |
| The number of lymph node dissection | 1 day |
| The number of positive lymph nodes | 1 day |