A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery
NCT ID: NCT02302794
Last Updated: 2014-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1056 participants
INTERVENTIONAL
2014-08-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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open surgery
Conventional procedure
open surgery
Patients in this arm undergo radical resection of gastric cancer in open surgery.Open surgery is a conventional technique for gastric cancer patients.
laparoscopic surgery
Minimum invasive procedure
laparoscopic surgery
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.
Interventions
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open surgery
Patients in this arm undergo radical resection of gastric cancer in open surgery.Open surgery is a conventional technique for gastric cancer patients.
laparoscopic surgery
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Cai Kailin
OTHER
Responsible Party
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Cai Kailin
Associate chief physician of gastrointestinal surgery
Principal Investigators
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Guobin Wang, MD,PhD
Role: STUDY_CHAIR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Kaixiong Tao, MD,PhD
Role: STUDY_DIRECTOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Guobin Wang, MD,PhD
Role: primary
Other Identifiers
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ChiCTR-TRC-14004877
Identifier Type: -
Identifier Source: org_study_id