A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery

Study Overview
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Brief Summary
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evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current standard surgical treatment model D2 open approach distal gastric resection (distal gastrectomy, D2 lymphadenectomy).

Detailed Description
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Study type：Interventional Study phase：Phase III Objectives of Study：to evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current standard surgical treatment model D2 open approach distal gastric resection (distal gastrectomy, D2 lymphadenectomy).

Official Title
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Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Long-term Outcomes Between Laparoscopy-assisted and Open Distal Subtotal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Conditions
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Locally Advanced 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: 18 years   75 years; the primary adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma); clinical stage T2-4a, N0-3, M0 (according to AJCC-7th TNM staging); to perform distal gastrectomy, D2 lymph node dissection surgical can obtain R0 resection (multiple primary cancers also apply) ECOG performance status 0/1; ASA score I-III; patient informed consent. Exclusion Criteria: pregnant or lactating women; serious mental illness; upper abdominal surgery (except laparoscopic cholecystectomy ); gastric surgery (including for gastric ESD / EMR); imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm) other malignant diseases in 5 years; implemented or recommended neoadjuvant therapy in patients with gastric cancer ; have unstable angina or myocardial infarction within six months; (9) have cerebral infarction or cerebral hemorrhage within 6 months; (10) sustained systemic glucocorticoid treatment history within 1 month; (11) have other diseases needed operative treatment at the same time; (12) complications (bleeding, perforation, obstruction) required emergency surgery; (13) Pulmonary function tests FEV1 <50% of predicted value.

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
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 | Procedure: open surgery<br>* Patients in this arm undergo radical resection of gastric cancer in open surgery.Open surgery is a conventional technique for gastric cancer patients.<br>* Other names: open;|
| Experimental: laparoscopic surgery<br>Minimum invasive procedure | Procedure: laparoscopic surgery<br>* Patients in this arm undergo radical resection of gastric cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for gastric cancer patients.<br>* Other names: laparoscopic;|

What is the study measuring?
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Primary Outcome Measures

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