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A Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Long-term Outcome Between Robot-Assisted and Laparoscopic Distal Subtotal Gastrectomy with D2 lymphadenectomy for Locally Advanced Gastric Cancer

A Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Long-term Outcome Between Robot-Assisted and Laparoscopic Distal Subtotal Gastrectomy with D2 lymphadenectomy for Locally Advanced Gastric Cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023933
Enrollment
Unknown
Registered
2019-06-19
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-06-26

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

Conditions

Locally Advanced Gastric Cancer

Interventions

Sponsors

the First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) 18 years old < age <75 years old; 2) gastric primary lesions were pathologically diagnosed by endoscopic biopsy as gastric adenocarcinoma (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, imaged cell carcinoma sig, and poorly differentiated adenocarcinoma por); 3) preoperative clinical stages were t2-4a, n0-3 and M0(see preoperative evaluation plan for details). According to ajcc-7thtnm tumor stage); 4) it is expected that the results of RO surgery can be obtained by distal subtotal gastrectomy and D2 lymph node dissection (multiple primary cancers are also applicable); 5) preoperative ECOG physical state score 0/1; 6) preoperative ASA score i-iii; 7) informed consent of the patient.

Exclusion criteria

Exclusion criteria: 1) pregnant or lactating women; 2) severe mental illness; 3) history of upper abdominal surgery (except laparoscopic cholecystectomy); 4) history of gastric surgery (including ESD/EMR for gastric cancer); 5) preoperative imaging examination suggested regional fusion of enlarged lymph nodes (maximum diameter = 3cm) 6) history of other malignant diseases within 5 years; 7) gastric cancer patients who have been tested or recommended for neoadjuvant therapy; 8) history of unstable angina pectoris or myocardial infarction within 6 months; 9) a history of cerebral infarction or cerebral hemorrhage within 6 months; 10) a history of continuous systemic corticosteroid therapy within 1 month; 11) simultaneous surgical treatment for other diseases is required; 12) complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery; 13) lung function test FEVI< 50% of the estimated value.

Design outcomes

Primary

MeasureTime frame
3-year disease-free survival;

Secondary

MeasureTime frame
3-year overall survival;3-year locoregional recurrence rate;postoperative complication rate;Postoperative recovery time; postoperative 30-day mortality rate;

Countries

China

Contacts

Public ContactTaiyuan Li

the First Affiliated Hospital of Nanchang University

jylitaiyuan@sina.com+86 0791-88694893

Outcome results

None listed

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