A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Gastrectomy in Neoadjuvant Gastric Cancer Patients

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To evaluate the clinical efficacy of robot radical Gastrectomy and laparoscopic radical Gastrectomy, patients with gastric adenocarcinoma (cT2N+M0 or cT3-4a/N+M0, phase II and III) undergoing neoadjuvant treatment were selected as subjects.

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

• 18 years old ≤ 75 years old male or female;

• The primary gastric lesion was diagnosed as gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, Signet ring cell carcinoma, poorly differentiated adenocarcinoma) by endoscopic biopsy histopathology;

• Before neoadjuvant treatment, the preoperative clinical staging was confirmed to be II and III (cT2N+M0 or cT3-4a/N+M0) through gastroscopy/ultrasound gastroscopy, enhanced CT/MR, or diagnostic laparoscopic exploration (based on AJCC-8th TNM tumor staging);

• 2-4 cycles of neoadjuvant therapy (chemotherapy+/- targeted/immunotherapy, simple chemotherapy);

• After new adjuvant treatment, radical Gastrectomy is feasible after MDT discussion;

• Preoperative ECOG physical condition score of 0/1 or Karst score ≥ 70%;

• Preoperative ASA score I-III;

• The expected survival period exceeds 6 months;

• Willing and able to comply with the research protocol;

⁃ Sign a written informed consent form before enrollment and be fully aware of the right to withdraw from this study at any time.

Locations
Other Locations
China
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
RECRUITING
Qingdao
Contact Information
Primary
Yanbing Zhou
zhouyanbing999@aliyun.com
13708971773
Time Frame
Start Date: 2023-07-07
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 588
Treatments
Experimental: Robotic group
Robotic gastrectomy
Active_comparator: Laparoscopic group
Laparoscopic gastrectomy
Related Therapeutic Areas
Sponsors
Leads: The Affiliated Hospital of Qingdao University

This content was sourced from clinicaltrials.gov