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A randomized controlled study of the effects of laparoscopic and robotic D2 radical gastrectomy on short-term and long-term clinical outcomes in neoadjuvant gastric cancer patients

A randomized controlled study of the effects of laparoscopic and robotic D2 radical gastrectomy on short-term and long-term clinical outcomes in neoadjuvant gastric cancer patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039114
Enrollment
Unknown
Registered
2020-10-17
Start date
2020-10-15
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

Stamach cancer

Interventions

L group:Laparoscopic surgery
R group:Robot-assisted surgery

Sponsors

Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years, male or female bedridden; 2. Patients with Karnofsky score >= 70%; 3. Patients with gastric adenocarcinoma confirmed by biopsy; 4. Patients with ct2-4an + M0 confirmed by EUS and enhanced CT / MRI; 5. Patients with no history of chemotherapy or radiotherapy before diagnosis; 6. Patients with tumors located in the middle and lower third of the stomach; 7. Patients who can achieve gross resection (R0 / 1) by minimally invasive distal gastrectomy plus D2 lymph node dissection; 8. Hematological and biochemical indexes: hemoglobin >= 80g / L, absolute neutrophil count >= 1.5 x 10^9/L, platelet >= 100 x 10^9/L, liver and kidney function were normal; 9. Those patients without severe concomitant diseases that affect survival within 5 years; 10. Patients who are willing and able to comply with the study protocol; 11. Patients who have reached a written agreement before registration and are fully aware of the right to withdraw from the study at any time without any loss.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating objects; 2. Patients without controlled seizures, central nervous system diseases or mental disorders; 3. Patients with a history of upper abdominal surgery (except laparoscopic cholecystectomy); 4. Patients with history of gastric surgery (including endoscopic submucosal dissection and endoscopic mucosal resection and other diagnostic operations); 5. Patients with other malignant diseases within 5 years; 6. Patients with clinically severe or active heart disease, such as symptomatic coronary heart disease, congestive heart failure of NYHA class II or above, severe arrhythmia or myocardial infarction within 6 months; 7. Patients with cerebral hemorrhage or infarction within 6 months; 8. Those patients receiving immunosuppressive therapy for organ transplant recipients; 9. Patients with severe recurrent infection or other severe concomitant diseases; 10. Patients with cerebral hemorrhage or infarction within 6 months; 11. Patients with other diseases requiring simultaneous operation; 12. Patients who need emergency operation due to tumor emergency (such as bleeding, perforation, obstruction); 13. Patients participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
blood loss;duration of surgery;Compliance rate of lymph node dissection;Operative mortality;Negative rate of tumor resection margin and length of upper and lower resection end;Surgical complications;Postoperative pain;3-year survival rate;3-year survival rate;Quality of Life;First exhaust time;First time of fluid intake;Time to resume normal diet after operation;Number of lymph nodes dissected;

Countries

China

Contacts

Public ContactZhou Yanbing

Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University

zhouyanbing998@aliyun.com+86 13708971773

Outcome results

None listed

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