Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection
- Conditions
- Gastric CancerTotal GastrectomySplenic Hilum Lymph Nodes Dissection
- Interventions
- Procedure: Laparoscopic-assisted total gastrectomyProcedure: Open total gastrectomy
- Registration Number
- NCT02711033
- Lead Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Brief 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 144
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laparoscopic-assisted total gastrectomy Laparoscopic-assisted total gastrectomy Patients including in the laparoscopic-assisted total gastrectomy (LATG) group will undergo LATG with spleen-preserving splenic hilum lymph nodes dissection. Open total gastrectomy Open total gastrectomy Patients who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.
- Primary Outcome Measures
Name Time Method Early complication rate 30 days The early complication rate is defined as the event observed during operation and within 30 days after surgery.
- Secondary Outcome Measures
Name Time Method Number of group No.10 lymph nodes harvested 7 days Number of lymph nodes posterior to splenic vessel 7 days Poster-operative recovery course 30 days Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course.
3-year disease free survival rate 3 years 5-year overall survival rate 5 years Metastasis rate of lymph nodes posterior to splenic vessel 7 days Operative time Intraoperative Time of splenic hilum lymph nodes dissection Intraoperative Operative blood loss Intraoperative It will be assessed with the unit of "ml".
Incision length 7 days Number of total lymph nodes harvested 7 days
Trial Locations
- Locations (1)
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China