Effect of Laparoscopy-Assisted Distal Gastrectomy for Locally Advanced Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2 radical surgery for distal advanced gastric cancer.

Detailed Description
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In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth I or BillrothII methods will be used for gastric reconstruction for all cases. For anastomosis, absorbable suture is used. Anastomotic diameter is 5 6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.

Official Title
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Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy(ODG) for Locally Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: open surgery
* Procedure: laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: older than 18 years old，including 18 years old Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma) Cancer core: located at lower part of stomach Preoperative cancer stage : cT2-4a,N0-3,M0 (according to AJCC-7th TNM staging) surgery：subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection ASA score: ≤ 3;ECOG performance status 0/1 Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available) Exclusion Criteria: Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy) Patient who was treated because of systemic inflammatory disease Pregnant patient or lactating women Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis serious mental illness gastric surgery (including for gastric ESD / EMR) imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm) other malignant diseases in 5 years have unstable angina or myocardial infarction within six months have cerebral infarction or cerebral hemorrhage within 6 months sustained systemic glucocorticoid treatment history within 1 month have other diseases needed operative treatment at the same time complications (bleeding, perforation, obstruction) required emergency surgery Pulmonary function tests FEV1 <50% of predicted value.

Ages Eligible for Study
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Minimum Age: 18 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 surgery<br>Conventional procedure,Open surgery | Procedure: open surgery<br>* Subtotal gastectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dessection(around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically.<br>* Other names: ODG;|
| Experimental: laparoscopic surgery<br>Minimum invasive procedure，Laparoscopic surgery | Procedure: laparoscopic surgery<br>* Patients in this arm undergo radical resection of gastric cancer in laparoscopic surgery.10 mm trocar under umbilicus, 12 mm and 5 mm trocar at the right flank area are inserted into abdominal wall. Another two 5 mm trocar are inserted into the both midline of subcostal line. The devices for operation are inserted through the trocars. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. Dissected stomach and lymph node are collected through additional 5-10 cm incision at the preexisting epigastric incision.<br>* Other names: LADG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication rate | Surgical complications within 30 days after surgery | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate | 3-year disease free survival rate | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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D2, gastric cancer, laparoscopic, open, surgery