A Multicenter, Prospective, Randomized Controlled Clinical Study of Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: evaluate the long-term efficacy and safety of robotic gastrectomy for locally advanced gastric cancer\] in \[Participant Population: patients with locally advanced gastric cancer, aged \>18 years and \<75 years\]. The primary questions it seeks to answer are: Is the 3-year disease-free survival rate of robotic gastrectomy non-inferior to that of laparoscopic gastrectomy? Is the perioperative safety of robotic gastrectomy superior to that of laparoscopic gastrectomy? Researchers will compare \[Intervention Groups: Robotic Gastrectomy vs. Laparoscopic Gastrectomy\] to determine whether \[robotic surgery offers advantages in long-term efficacy and perioperative safety\]. Participants will: Sign an informed consent form and be randomly assigned to either the robotic surgery group or the laparoscopic surgery group. Undergo the assigned surgical procedure and receive regular follow-up visits (at 30 days, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 2 years, 2.5 years, and 3 years postoperatively). Complete physical examinations, blood tests (including complete blood count, biochemical markers, and tumor markers), and imaging studies (such as abdominal CT, upper gastrointestinal endoscopy, and chest X-ray) during the follow-up period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age \> 18 years and \< 75 years.

• Primary gastric lesion histologically confirmed as gastric adenocarcinoma (including papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma, etc.) via endoscopic biopsy.

• Preoperative clinical staging as locally advanced gastric cancer (cT2-4a, N0-3, M0) according to the 8th edition of the AJCC TNM staging system.

• No distant metastasis on preoperative examination, and no direct invasion of the pancreas, spleen, or other adjacent organs.

• Preoperative ECOG performance status score of 0 or 1.

• Preoperative ASA (American Society of Anesthesiologists) physical status score of I-III.

• Consent to participate in the study and signing of the informed consent form.

Locations
Other Locations
China
The Southwest hospital of AMU
RECRUITING
Chongqing
The Southwest hospital of AMU
NOT_YET_RECRUITING
Chongqing
Contact Information
Primary
Yan Shi
shiyandoctor@sina.com
13752909448
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 740
Treatments
Experimental: Robotic Gastrectomy
Active_comparator: Laparoscopic Gastrectomy
Sponsors
Leads: Southwest Hospital, China

This content was sourced from clinicaltrials.gov

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