Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.

Detailed Description
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To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.

Official Title
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A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: laparoscopy assisted distal gastrectomy
* Procedure: open distal gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically proven primary gastric adenocarcinoma T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location No evidence of other distant metastasis not stump carcinoma,(vi) aged 20-80 year old performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection adequate organ functions defined as indicated below: WBC 3000/mm3, WBC 12 000/mm3 Hb 8.0 g/dl without any transfusion 2 weeks before enrollment Plt 100 000/mm3 AST 100 IU/l ALT 100 IU/l T.Bil 2.0 mg/dl written informed consent Exclusion Criteria: active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) pregnant or breast-feeding women severe mental disorder systemic administration of corticosteroids unstable angina or myocardial infarction within 6 months of the trial unstable hypertension severe respiratory disease requiring continuous oxygen therapy previous upper abdominal surgery except laparoscopic cholecystectomy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: open distal gastrectomy<br>open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer | Procedure: open distal gastrectomy<br>* open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer<br>* Other names: ODG;|
| Experimental: laparoscopy assisted distal gastrectomy<br>laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer | Procedure: laparoscopy assisted distal gastrectomy<br>* laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer<br>* Other names: LADG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| noncompliance rate | A Case will be designated as noncompliant when there are more than one missing lymph node station according to the guidelines of The Japanese Research Society for Gastric Cancer (JRSGC) lymph node grouping | postoperative 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative surgical complications | Major and minor, and short term and long term complications related with surgery will be monitored and recorded according to classification of Accordion Severity Classification of Postoperative Complications; Expanded Classification. | postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months | 
| operating time | From skin incision to wound closure | operation day | 
| time to first flatus | the day when a patient relieve gastrointestinal gas | postoperative 1 week | 
| number of retrieved lymph nodes |  | postoperative 1 week | 
| number of retrieved lymph nodes at each stations |  | postoperative 1 week | 
| proximal resection margin |  | postoperative 1 week | 
| distal resection margin, |  | postoperative 1 week | 
| unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons | Three randomly assigned laparoscopic gastric cancer surgeons would evaluate the uneditted video and photoes and validate the lymph node dissection according to each stations.When the three surgeons agree that D2 lymph node dissection was performed, it is considered as unanimity. | postoperative 3 months | 
| 3-year disease free survival |  | postoperative 3 years |