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A Prospective, Multicenter, Non-inferiority Randomized Controlled Study Comparing the Safety and Efficacy of Remote versus On-site Robot-Assisted Radical Distal Gastrectomy

A Prospective, Multicenter, Non-inferiority Randomized Controlled Study Comparing the Safety and Efficacy of Remote versus On-site Robot-Assisted Radical Distal Gastrectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117973
Enrollment
Unknown
Registered
2026-01-30
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Distal gastric cancer

Interventions

Remote robot-assisted distal gastrectomy group:Remote robot-assisted distal gastrectomy
Domestic robot-assisted distal gastrectomy Group:Local robot-assisted distal gastrectomy

Sponsors

First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18 - 75 years; (2) Pathologically confirmed primary gastric adenocarcinoma (including papillary, tubular, mucinous, signet-ring cell, or poorly differentiated adenocarcinoma) via endoscopic biopsy, with the tumor located in the middle or lower third of the stomach; (3) Preoperative clinical stage (AJCC 8th Edition TNM staging): cT1-4a, N0/+, M0, and scheduled to undergo distal gastrectomy; (4) No evidence of distant metastasis on preoperative imaging, no significant para-aortic lymphadenopathy, and no direct invasion of the pancreas, spleen, or other adjacent organs; (5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; (6) American Society of Anesthesiologists (ASA) physical status classification of I, II, or III; (7) Provision of written informed consent.

Exclusion criteria

Exclusion criteria: (1) Pregnancy or lactation; (2) Severe psychiatric disorders; (3) History of previous upper abdominal surgery (excluding laparoscopic cholecystectomy); (4) Previous gastric resection, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD); (5) History of other malignancies within the past 5 years; (6) Preoperative imaging suggesting regional lymphadenopathy (long-axis diameter >3 cm), including significant enlargement or fusion of station No. 10 lymph nodes; (7) Prior neoadjuvant chemotherapy or radiotherapy; (8) Unstable myocardial infarction, angina, or cerebrovascular accident within 6 months before surgery; (9) History of continuous systemic corticosteroid use within 1 month; (10) Forced expiratory volume in 1 second (FEV1) <50% of predicted value; (11) Planned concurrent surgical treatment for other diseases; (12) Emergency surgery required due to gastric cancer complications such as bleeding, obstruction, or perforation.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative complications;

Secondary

MeasureTime frame
;3-year recurrence rate;The number of lymph nodes dissected;Time to first bowel movement;The time of first liquid food intake;Length of postoperative hospital stay;Weight regain;Changes in Albumin;Changes in Cholesterol;Duration of surgery;Changes in Hemoglobin;Change in white blood cell count;Hospitalization expenses;

Countries

China

Contacts

Public ContactXiaohui Du

Chinese People's Liberation Army General Hospital

duxiaohui301@sina.com+86 139 0125 9795

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026