Status:
UNKNOWN
A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery
Lead Sponsor:
Cai Kailin
Conditions:
Locally Advanced Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 treat...
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 gastrect...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
1056 Patients enrolled
Trial Details
Trial ID
NCT02302794
Start Date
August 1 2014
End Date
August 1 2016
Last Update
November 27 2014
Active Locations (1)
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1
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022