Stomach Neoplasms
Conditions
Keywords
Stomach Neoplasms, Laparoscopy, Advanced Gastric Cancer, Neoadjuvant Chemotherapy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURELaparoscopic-assisted gastrectomy with D2 lymphadenectomy
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
Sponsors
Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 75 years * Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy * cT2-4aN+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition * No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor. * Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) * American Society of Anesthesiology score (ASA) class I, II, or III * Written informed consent
Exclusion criteria
* Women during pregnancy or breast-feeding * Severe mental disorder * History of previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection) * History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection * History of other malignant disease within past five years * History of unstable angina or myocardial infarction within past six months * History of cerebrovascular accident within past six months * History of continuous systematic administration of corticosteroids within one month * Requirement of simultaneous surgery for other disease * Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * FEV1\<50% of predicted values
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scale the amount of abdominal drainage | 10 days | Scale the amount of abdominal drainage |
| Blood transfusion | 10 days | Blood transfusion |
| The number of positive lymph nodes | 1 days | The number of positive lymph nodes |
| Rates of combined organ resection | 1 day | Combined organ resection performing by severe injury or abdominal adhesions |
| The number of lymph node dissection | 1 day | The number of lymph node dissection |
| The variation of weight | 12 months | The variation of weight on postoperative 3, 6, 9 and 12 months |
| The daily highest body temperature | 7 days | The daily highest body temperature before discharge |
| Time to first flatus | 10 days | Time to first flatus |
| Time to first liquid diet | 10 days | Time to first liquid diet |
| Pathological response | 30 days | Pathological response grading was performed according to the Becker TRG system |
| Radiological response | 30 days | Radiological response and progression were assessed according to RECIST version 1.1 |
| 3-year disease free survival rate | 36 months | 3-year disease free survival rate |
| 3-year overall survival rate | 36 months | 3-year overall survival rate |
| 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 |
| Mortality | 30 days | The early mortality are defined as the event observed within 30 days after surgery. |
| Time to soft diet | 10 days | Time to soft diet |
| Intraoperative lymph node dissection time | 1 days | 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. |
| Intraoperative blood loss | 1 days | Intraoperative blood loss |
| Time of operation | 1 day | Time of operation |
| Intraoperative injury | 1 days | Intraoperative injury |
| The amount of use of titanium clip | 1 days | The amount of use of titanium clip |
| The rate of conversion to laparotomy | 1 days | The rate of conversion to laparotomy |
| The variation of albumin | 12 month | The variation of albumin on postoperative 3, 6, 9 and 12 months |
| The results of endoscopy | 12 month | the results of endoscopy on postoperative 3 and 12 months |
| The values of white blood cell count | 7 days | the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded |
| The values of hemoglobin | 7 days | the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. |
| The values of C-reactive protein | 7 days | the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. |
| The values of prealbumin | 7 days | the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. |
| Duration of hospital stay | 10 days | Duration of hospital stay |
| Late postoperative complication | 36 months | The late postoperative complication was defined as the event observed within the period from postoperative day 31th to the end of month 36th. |
| Adverse events | 30 days | 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) |
| Time to first ambulation | 10 days | The data of postoperative recovery course |
Outcome results
None listed