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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

Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Long-term Outcomes be

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004877
Enrollment
Unknown
Registered
2014-06-09
Start date
2014-07-31
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Gastric Cancer

Interventions

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Age
18 Years to 75 Years

Inclusion 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

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

MeasureTime frame
3-year disease free survival rat;

Countries

China

Contacts

Public ContactWang Guobin
liu.xh@foxmail.com+86 027-85726301

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026