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The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection.
The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection. Actually, if the 14v lymph node metastasis is suspected before surgery, it is excluded from the study. In a retrospective study conducted in our hospital, we compared the patients with the 14v lymphadenectomy group and those without the 14v lymphadenectomy group, the survival rate of the 14v lymphadenectomy group was 11% higher than that of the 14v non-lymphadenectomy group.Previous studies have suggested that the presence of metastatic lymph nodes in the 14v lymph node is not good and that removal of the 14v lymph node does not affect prognosis. However, if the lymph node is a continuous tissue and the transition to the 14v lymph node is confirmed microscopically, a negative prognosis may be expected because it is likely that the cancer has spread to the distal lymph node. In addition, inadequate resection of the lymphatic or 14v lymph node adjacent to the 14v lymph node in the absence of evidence of metastasis of the 14v lymph node under microscopic examination indicates that cancer may spread even after curative surgery, To prevent cancer metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D2 lymphadenectomy | Active Comparator | Subtotal gastrectomy with D2 lymphadnectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) could be performed in this arm |
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| D2 and #14v lymphadenectomy | Experimental | Subtotal gastrectomy with D2 (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) and lymph node #14v lymphadnectomy could be performed in this arm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D2 lymphadenectomy | Procedure | Subtotal gastrectomy with D2 lymphadenectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) is conventional surgery in patients with advanced gastric cancer such as T3N+ or T4N+ stage. |
| Measure | Description | Time Frame |
|---|---|---|
| Superiority verification of disease-free survival after lymphadenectomy for D2 + 14v lymph node dissection in gastric resection in patients with T3N + and T4N + stomach cancer | Patients were randomized to an intention-to-treat population. The primary efficacy assessment was performed at the end of the 3-year follow-up period. The free-disease survival rates of the two groups were compared by log rank test. | the last recruited patient was followed up for 3 years |
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<Inclusion Criteria>
Histologically proven primary gastric adenocarcinoma
T3N+, T4N+ by CT scan (AJCC 7th classification)
Distal margin of gastric cancer Location of distal margin of gastric cancer ; antrum, or angle of the stomach
No evidence of other distant metastasis
Age ≥ 20 year old
Performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
No prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
Adequate organ functions defined as indicated below:
Written signed informed consent
<Exclusion Criteria>
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HONG MAN YOON, MD | Contact | +82-31-920-1710 | red10000@ncc.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| HONG MAN YOON, MD | National Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Incheon St. Mary'S Hospital | Recruiting | Incheon | Bupyeong-gu | 21431 | South Korea |
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| D2 and #14v lymphadenectomy | Procedure | Subtotal gastrectomy with D2 (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) and #14v lymphadenectomy is experimental surgery in patients with advanced gastric cancer such as T3N+ or T4N+ stage. |
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| Dongnam Inst. of Radiological & Medical Sciences | Recruiting | Busan | Gijang-gun | 46033 | South Korea |
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| Gyeongsang national university hospital | Recruiting | Gyeongsang | Gingu-si | 52727 | South Korea |
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| National Cancer Center | Recruiting | Gyeonggi-do | Goyang-si | 10408 | South Korea |
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| catholic university of korea,Seoul ST. Mary's Hospital. | Recruiting | Seocho | Seoul | 06591 | South Korea |
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| Severance Hospital | Recruiting | Seoul | Sincon | 03722 | South Korea |
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| Asan Medical Center | Recruiting | Seoul | Songpa-gu | 05505 | South Korea |
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| A JOU University medical center | Recruiting | Gyeonggi-do | Suwon-si | 16499 | South Korea |
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| Pusan National University Yangsan Hospital | Recruiting | Gyeongsang | Yangsan-si | 50612 | South Korea |
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| Gyeongsang National University Changwon hospital | Recruiting | Changwon | 51472 | South Korea |
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| Dankook University Hospital | Recruiting | Cheonan | 31116 | South Korea |
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| The CATHOLIC University of KOREA, INCHEON ST.MARY's hospital | Recruiting | Incheon | 21431 | South Korea |
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| 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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