Stomach Neoplasms
Conditions
Keywords
Stomach Neoplasms, Totally Laparoscopic Total Gastrectomy, Laparoscopy Assisted Total Gastrectomy
Brief summary
The purpose of this study is to explore clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer.
Interventions
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Totally Laparoscopic Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
PROCEDURELaparoscopy Assisted Total Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Laparoscopy Assisted Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
Sponsors
Fujian Medical University
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. Age between 18 to 75 years old 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition） 4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations 5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale 6. ASA (American Society of Anesthesiology) class I to III 7. Written informed consent
Exclusion criteria
1. Pregnant and lactating women 2. Suffering from severe mental disorder 3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) 4. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer) 5. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node 6. History of other malignant disease within the past 5 years 7. History of previous neoadjuvant chemotherapy or radiotherapy 8. History of unstable angina or myocardial infarction within the past 6 months 9. History of cerebrovascular accident within the past 6 months 10. History of continuous systematic administration of corticosteroids within 1 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 the predicted values
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall postoperative morbidity rates | 30 days | Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free 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. |
| Intraoperative morbidity rates | 1 day | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. |
| Time to first ambulation | 30 days | Time to first ambulation in hours is used to assess the postoperative recovery course. |
| Time to first flatus | 30 days | Time to first flatus in days is used to assess the postoperative recovery course. |
| Time to first liquid diet | 30 days | Time to first liquid diet in days is used to assess the postoperative recovery course. |
| Time to first soft diet | 30 days | Time to first soft diet in days is used to assess the postoperative recovery course. |
| Duration of postoperative hospital stay | 30 days | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. |
| 3-year overall survival rate | 36 months | — |
| The variation of weight | 3, 6, 9 and 12 months | The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life. |
| The variation of cholesterol | 3, 6, 9 and 12 months | The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life. |
| The results of endoscopy | 3 and 12 months | The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life. |
| The variation of body temperature | 8 days | The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response. |
| The variation of white blood cell count | Preoperative 3 days and postoperative 1, 3, and 5 days | The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. |
| The variation of hemoglobin | Preoperative 3 days and postoperative 1, 3, and 5 days | The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. |
| The variation of C-reactive protein | Preoperative 3 days and postoperative 1, 3, and 5 days | The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. |
| Postoperative pain | 30 days | Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course. |
Outcome results
None listed