Gastric Cancer
Conditions
Keywords
Gastric Cancer, Splenic Hilum Lymph Nodes Dissection, Gastrectomy
Brief summary
Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.
Detailed description
Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 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 total gastrectomy (LTG) 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. Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare the early results of this procedure with open total gastrectomy (OTG).
Interventions
PROCEDURELaparoscopic total gastrectomy
When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.
PROCEDUREOpen total gastrectomy
When the participants 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
Chinese PLA General Hospital
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
1. Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy; 2. cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition. 3. Eastern Cooperative Oncology Group (ECOG): 0 or 1; 4. American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ; 5. Written informed consent.
Exclusion criteria
1. Pregnant or breast-feeding women; 2. Severe mental disorder; 3. Previous upper abdominal surgery (except laparoscopic cholecystectomy); 4. Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection; 5. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging; 6. Other malignant disease within the past 5 years; 7. Previous neoadjuvant chemotherapy or radiotherapy; 8. Contraindication to general anesthesia (severe cardiac and/or pulmonary disease); 9. Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of group Splenic Hilum (No.10) lymph nodes harvested | 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival rate | 3 years | — |
| Quality of life | 1 year | It will be assessed by questionnaire (WHO quality of life-100) |
| Operative blood loss | Intraoperative | — |
| Time of splenic hilum lymph nodes dissection | Intraoperative | — |
| 3-year disease free survival rate | 3 years | — |
| Post-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 |
| Early complication rate | 30 days | The early complication rate is defined as the event observed during operation |
| Operative time | Intraoperative | — |
| Number of total lymph nodes harvested | 7 days | — |
Countries
China
Contacts
Primary ContactHongqing Xi, Master
Outcome results
None listed