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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02302794

Enrollment

1056

Registered

2014-11-27

Start date

2014-08-31

Completion date

2016-08-31

Last updated

2014-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Gastric Cancer

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).

Interventions

PROCEDUREopen surgery

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

PROCEDURElaparoscopic surgery

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
3-year disease free survival rate	three years

Countries

China

Contacts

Primary ContactGuobin Wang, MD,PhD

wangguobin1954@126.com+86 027 85726139

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026