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Laparoscopic distal subtotal gastrectomy with lymph node dissection for treatment of gastric cancer is popular in East Asian countries. However, the long-term follow-up outcome based on randomized clinical trial (RCT) is still rare. Some studies indicated that laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, the application of it is still limited because of lack of solid evidence on the oncologic efficacy. Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 80 percent of all gastric cancer cases in China. Before the clinical application of laparoscopic procedure for the treatment with curative intent to advanced gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must be verified.Accordingly, the comparison of long-term outcome between laparoscopic and open distal subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer based on a well designed RCT is needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic gastrectomy | Experimental | Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group. |
|
| Open gastrectomy | Active Comparator | Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic gastrectomy | Procedure |
| ||
| Open gastrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | 30 days | |
| 3-year overall survival rate | 36 months | |
| 3-year recurrence pattern |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongbo Wei, M.D. Ph.D. | Contact | +86-189-2210-2969 | drweihb@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Procedure |
|
| 36 months |
| Mortality | 30 days |
| Morbidity | 36 months |
| Mortality | 36 months |
| Postoperative recovery situation | Time to first ambulation, flatus, liquid diet, soft diet and duration of hospital stay are used to assess the postoperative recovery situation. | 10 days |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |