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The purpose of this study is to explore the safety, feasibility, long-term and oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy.
A prospective single-arm study designed to further evaluate laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy will be performed, to evaluate the safety, feasibility, long-term and oncological outcomes. The evaluation parameters are perioperative mobility and mortality, perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic-assisted Gastrectomy | Experimental | Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic-assisted gastrectomy with D2 lymphadenectomy | Procedure | After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic-assisted gastrectomy with D2 lymphadenectomy 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | The early postoperative complication are defined as the event observed within 30 days after surgery.Postoperative complications were graded according to the Clavien-Dindo classification system | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological response | Pathological response grading was performed according to the Becker TRG system | 30 days |
| Radiological response | Radiological response and progression were assessed according to RECIST version 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy
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|
| 30 days |
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months |
| 3-year overall survival rate | 3-year overall survival rate | 36 months |
| 3-year recurrence pattern | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type | 36 months |
| Mortality | The early mortality are defined as the event observed within 30 days after surgery. | 30 days |
| Time to first ambulation | The data of postoperative recovery course | 10 days |
| Rates of combined organ resection | Combined organ resection performing by severe injury or abdominal adhesions | 1 day |
| The number of lymph node dissection | The number of lymph node dissection | 1 day |
| The variation of weight | The variation of weight on postoperative 3, 6, 9 and 12 months | 12 months |
| The daily highest body temperature | The daily highest body temperature before discharge | 7 days |
| Time to first flatus | Time to first flatus | 10 days |
| Time to first liquid diet | Time to first liquid diet | 10 days |
| Time to soft diet | Time to soft diet | 10 days |
| Scale the amount of abdominal drainage | Scale the amount of abdominal drainage | 10 days |
| Blood transfusion | Blood transfusion | 10 days |
| The number of positive lymph nodes | The number of positive lymph nodes | 1 days |
| Intraoperative lymph node dissection time | intraoperative lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node and jejunal lymph nodes adjacent to the anastomosis. | 1 days |
| Intraoperative blood loss | Intraoperative blood loss | 1 days |
| Time of operation | Time of operation | 1 day |
| Intraoperative injury | Intraoperative injury | 1 days |
| The amount of use of titanium clip | The amount of use of titanium clip | 1 days |
| The rate of conversion to laparotomy | The rate of conversion to laparotomy | 1 days |
| The variation of albumin | The variation of albumin on postoperative 3, 6, 9 and 12 months | 12 month |
| The results of endoscopy | the results of endoscopy on postoperative 3 and 12 months | 12 month |
| The values of white blood cell count | the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded | 7 days |
| The values of hemoglobin | the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. | 7 days |
| The values of C-reactive protein | the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. | 7 days |
| The values of prealbumin | the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. | 7 days |
| Duration of hospital stay | Duration of hospital stay | 10 days |
| Late postoperative complication | The late postoperative complication was defined as the event observed within the period from postoperative day 31th to the end of month 36th. | 36 months |
| Adverse events | Adverse events (AEs) of neoadjuvant chemotherapy were assessed at each visit per the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) | 30 days |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |