The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Laparoscopic-assisted Gastrectomy Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group |
Procedure: Laparoscopic-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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 first ambulation [10 days]
The data of postoperative recovery course
- 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
- Time to soft diet [10 days]
Time to soft diet
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age from 18 to 75 years
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Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
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cT2-4aN+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
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No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
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Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
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American Society of Anesthesiology score (ASA) class I, II, or III
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Written informed consent
Exclusion Criteria:
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Women during pregnancy or breast-feeding
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Severe mental disorder
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History of previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection)
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History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
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History of other malignant disease within past five years
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History of unstable angina or myocardial infarction within past six months
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History of cerebrovascular accident within past six months
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History of continuous systematic administration of corticosteroids within one month
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Requirement of simultaneous surgery for other disease
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Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
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FEV1<50% of predicted values
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fujian Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FUGES-05