Clinical trial NCT02302794: A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Locally Advanced Gastric Cancer
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 1056
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Guobin Wang, MD,PhD
role: STUDY_CHAIR
affiliation: Wuhan Union Hospital, China
name: Kaixiong Tao, MD,PhD
role: STUDY_DIRECTOR
References: