NCT03264807

Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer

A Multicenter Randomized Controlled Trial of D2 Versus D2 + Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer (14VIGTORY Trial)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 518 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	D2 lymphadenectomy	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.
PROCEDURE	D2 and #14v lymphadenectomy	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.

Timeline

• Start date: 2015-08-06
• Primary completion: 2020-12-30
• Completion: 2021-12-31
• First posted: 2017-08-29
• Last updated: 2020-03-03

Locations

12 sites across 1 country: South Korea