Overall Survival
Conditions
Brief summary
This study is to conduct a randomized controlled trial of two kinds of radical gastrectomy for patients with proximal gastric cancer. One is laparoscopic D2 radical total gastrectomy combined with spleen-preserving No.10 lymph node dissection , another one is laparoscopic D2 radical total gastrectomy without clearing the No. 10 lymph nodes of the spleen. We explore the effect of the two procedures on the survival of patients, as well as the surgical complications associated with the two procedures, the number of lymph node dissection, the operation time and the amount of intraoperative blood loss. Furthermore, we also want to discuss the application value of laparoscopic lymph node dissection for spleen preservation in radical gastrectomy for proximal gastric cancer.
Interventions
PROCEDURED2 Lymphadenectomy including No. 10
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
PROCEDURED2 lymphadenectomy excluding No. 10
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
Sponsors
Jian Suo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age from 18 to 80 years 2. Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition 4. No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor. 5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) 6. American Society of Anesthesiology score (ASA) class I, II, or III 7. Written informed consent
Exclusion criteria
1. Women during pregnancy or breast-feeding 2. Severe mental disorder 3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy) 4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection 5. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging 6. History of other malignant disease within past five years 7. History of previous neoadjuvant chemotherapy or radiotherapy 8. History of unstable angina or myocardial infarction within past six months 9. History of cerebrovascular accident within past six months 10. History of continuous systematic administration of corticosteroids within one month 11. Requirement of simultaneous surgery for other disease 12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 13. FEV1\<50% of predicted values
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease free survival rate | 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of lymph node dissection | 1 day | — |
| The number of positive lymph nodes | 1 day | — |
| Morbidity | 30 days; 36 months | The early postoperative complication are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th. |
| 3-year overall survival rate | 36 months | — |
| 3-year recurrence pattern | 36 months | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type |
Countries
China
Contacts
Primary ContactJian Suo, Ph.D.
Backup ContactYuchen Guo, Ph.D.
Outcome results
None listed