NCT02711033

Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection

Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Gastric Cancer
• Splenic Hilum Lymph Nodes Dissection
• Total Gastrectomy

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic-assisted total gastrectomy	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.
PROCEDURE	Open total gastrectomy	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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-10-01
• Completion: 2019-04-01
• First posted: 2016-03-17
• Last updated: 2017-04-10

Locations

1 site across 1 country: China