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
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 1,056
- Locations
- 1
- Primary Endpoint
- 3-year disease free survival rate
Study Overview
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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
open surgery
Conventional procedure
Intervention: open surgery (Procedure)
laparoscopic surgery
Minimum invasive procedure
Intervention: laparoscopic surgery (Procedure)
Outcomes
Primary Outcomes
3-year disease free survival rate
Time Frame: three years
Secondary Outcomes
No secondary outcomes reported
Investigators
Cai Kailin
Associate chief physician of gastrointestinal surgery
Huazhong University of Science and Technology