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This study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy.
For advanced proximal gastric cancer, total gastrectomy with D2 lymphadenectomy is the standard surgical therapy. Apparently, lymph nodes (LNs) dissection along the splenic artery (No.11) and the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines. Nevertheless, complete removal of the No. 10 and No. 11d LNs is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic-assisted total gastrectomy (LATG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Herein, we aim to investigate the safety and feasibility of LATG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy (OTG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic-assisted total gastrectomy | Experimental | Patients including in the laparoscopic-assisted total gastrectomy (LATG) group will undergo LATG with spleen-preserving splenic hilum lymph nodes dissection. |
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| Open total gastrectomy | Active Comparator | Patients who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic-assisted total gastrectomy | Procedure | When patients with advanced proximal gastric cancer are randomized in the laparoscopic-assisted total gastrectomy (LATG) group, they will received LATG with spleen-preserving splenic hilum lymph nodes dissection. |
| Measure | Description | Time Frame |
|---|---|---|
| Early complication rate | The early complication rate is defined as the event observed during operation and within 30 days after surgery. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Intraoperative | |
| Time of splenic hilum lymph nodes dissection | Intraoperative | |
| Operative blood loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Wang, M.D., PH.D. | Contact | +86-13922255515 | wangwei16400@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Wang, M.D., PH.D. | Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| Open total gastrectomy | Procedure | When patients with advanced proximal gastric cancer are randomized in the open total gastrectomy (OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection. |
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It will be assessed with the unit of "ml". |
| Intraoperative |
| Incision length | 7 days |
| Number of total lymph nodes harvested | 7 days |
| Number of group No.10 lymph nodes harvested | 7 days |
| Number of lymph nodes posterior to splenic vessel | 7 days |
| Poster-operative recovery course | Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course. | 30 days |
| 3-year disease free survival rate | 3 years |
| 5-year overall survival rate | 5 years |
| Metastasis rate of lymph nodes posterior to splenic vessel | 7 days |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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