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

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer; Splenic Hilum Lymph Nodes Dissection; Total Gastrectomy

Treatments: Procedure: Open total gastrectomy; Procedure: Laparoscopic-assisted total gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02711033

GDPHCM-GI-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with advanced proximal gastric cancer （T2-T4a,N0-N3,M0）
• Informed consent
• Eastern Cooperative Oncology Group (ECOG): 0 ot 1
• American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ

Exclusion criteria

• Pregnancy or female in suckling period
• Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
• Severe mental disease
• Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor
• Body mass index (BMI) > 30 kg/m2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Laparoscopic-assisted total gastrectomy

Experimental group

Description:

Patients including in the laparoscopic-assisted total gastrectomy (LATG) group will undergo LATG with spleen-preserving splenic hilum lymph nodes dissection.

Treatment:

Procedure: Laparoscopic-assisted total gastrectomy

Open total gastrectomy

Active Comparator group

Description:

Patients who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.

Treatment:

Procedure: Open total gastrectomy