The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Procedure: Laparoscopic-assisted gastrectomy with D2 lymphadenectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic-assisted Gastrectomy<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach Neoplasms, Laparoscopy, Advanced Gastric Cancer, Neoadjuvant Chemotherapy