A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery

Cai Kailin1,056 enrolled

Overview

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 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,056

Conditions

Locally Advanced Gastric Cancer

Interventions

open surgeryPROCEDURE

Patients in this arm undergo radical resection of gastric cancer in open surgery.Open surgery is a conventional technique for gastric cancer patients.

laparoscopic surgeryPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Union Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

3-year disease free survival rate

Time frame: three years

Central Contacts

Guobin Wang, MD,PhD

CONTACT

+86 027 85726139 wangguobin1954@126.com

Data from ClinicalTrials.gov

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