Gastric Cancer, Splenic Hilum Lymph Nodes Dissection, Total Gastrectomy
Conditions
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).
Interventions
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.
PROCEDUREOpen 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.
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early complication rate | 30 days | The early complication rate is defined as the event observed during operation and within 30 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 3-year disease free survival rate | 3 years | — |
| Number of total lymph nodes harvested | 7 days | — |
| 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. |
| Incision length | 7 days | — |
Countries
China
Contacts
Primary ContactWei Wang, M.D., PH.D.
Outcome results
None listed