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

Phase 3

• Conditions: Locally Advanced Gastric Cancer
• Interventions: Procedure: open surgery; Procedure: laparoscopic surgery

• Registration Number: NCT02302794
• Lead Sponsor: Cai Kailin

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 Timeline

• Status Verified: 2014-07
• Study Start: 2014-08
• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-25
• Last Update Submitted: 2014-11-25
• Study First Posted: 2014-11-27
• Last Update Posted: 2014-11-27
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1056

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open surgery	open surgery	Conventional procedure
laparoscopic surgery	laparoscopic surgery	Minimum invasive procedure

Primary Outcome Measures

Name	Time	Method
3-year disease free survival rate	three years

Trial Locations

Locations (1)

Union Hospital, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China