Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer
- Conditions
- Gastric Cancer
- Interventions
- Procedure: D2 lymphadenectomyProcedure: D2 and #14v lymphadenectomy
- Registration Number
- NCT03264807
- Lead Sponsor
- National Cancer Center, Korea
- Brief Summary
The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 518
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description D2 lymphadenectomy D2 lymphadenectomy Subtotal gastrectomy with D2 lymphadnectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) could be performed in this arm D2 and #14v lymphadenectomy D2 and #14v lymphadenectomy 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
- Primary Outcome Measures
Name Time Method 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 the last recruited patient was followed up for 3 years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Dongnam Inst. of Radiological & Medical Sciences
🇰🇷Busan, Gijang-gun, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary'S Hospital
🇰🇷Incheon, Bupyeong-gu, Korea, Republic of
National Cancer Center
🇰🇷Gyeonggi-do, Goyang-si, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of
Gyeongsang National University Changwon hospital
🇰🇷Changwon, Korea, Republic of
A JOU University medical center
🇰🇷Gyeonggi-do, Suwon-si, Korea, Republic of
Gyeongsang national university hospital
🇰🇷Gyeongsang, Gingu-si, Korea, Republic of
catholic university of korea,Seoul ST. Mary's Hospital.
🇰🇷Seocho, Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Gyeongsang, Yangsan-si, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Sincon, Korea, Republic of
The CATHOLIC University of KOREA, INCHEON ST.MARY's hospital
🇰🇷Incheon, Korea, Republic of