A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery
Conditions
Locally Advanced Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: open surgery Type: Procedure
Name: laparoscopic surgery Type: Procedure
Overall Status
Recruiting
Summary
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
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. 18 years ~ 75 years;

2. the primary adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma);

3. clinical stage T2-4a, N0-3, M0 (according to AJCC-7th TNM staging);

4. to perform distal gastrectomy, D2 lymph node dissection surgical can obtain R0 resection (multiple primary cancers also apply)

5. ECOG performance status 0/1;

6. ASA score I-III;

7. patient informed consent.

Exclusion Criteria:

1. pregnant or lactating women;

2. serious mental illness;

3. upper abdominal surgery (except laparoscopic cholecystectomy );

4. gastric surgery (including for gastric ESD / EMR);

5. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)

6. other malignant diseases in 5 years;

7. implemented or recommended neoadjuvant therapy in patients with gastric cancer ;

8. 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.
Location
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China
Status: Recruiting
Contact: Guobin Wang, MD,PhD - +86 027 85726139 - wangguobin1954@126.com
Start Date
August 2014
Completion Date
August 2016
Sponsors
Cai Kailin
Source
Huazhong University of Science and Technology
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page