Status:
RECRUITING
The Safety and Efficacy of Robotic Assisted Surgery Using Vessel Sealer Extend in Locally Advanced Gastric Cancer
Lead Sponsor:
The First Hospital of Jilin University
Collaborating Sponsors:
Jiangsu Cancer Institute & Hospital
Beijing Tsinghua Changgeng Hospital
Conditions:
Locally Advanced Gastric Cancer
Gastric Adenocarcinoma
Eligibility:
All Genders
18-75 years
Brief Summary
Gastric cancer is the fifth most common malignancy and the fourth leading cause of cancer-related deaths. Surgical resection is the primary treatment, with laparoscopic-assisted gastrectomy (LG) being...
Detailed Description
Gastric cancer is the fifth most common malignancy worldwide and the fourth leading cause of cancer-related deaths. Surgical resection remains the primary treatment for the radical management of gastr...
Eligibility Criteria
Inclusion
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- Preoperative abdominal enhanced CT and lung CT (or PET-CT) showed no distant metastasis
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
Exclusion
- Gastric multiple primary carcinoma or multiple primary cancer
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection ) for gastric cancer)
- Preoperative gastric CT evaluation and chest and abdominal imaging evaluation were not performed before surgery, and the clinical stage of the tumor was not comprehensively evaluated
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
- History of other malignant disease within the past 5 years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- FEV1\<50% of the predicted values
- Women during pregnancy or breast-feeding
- Severe mental disorder
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- Preoperative evaluation requires combined organ resection
- Requirement of simultaneous surgery for other disease
Key Trial Info
Start Date :
November 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06881043
Start Date
November 20 2024
End Date
December 1 2029
Last Update
March 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
First Hospital of Jilin University
Changchun, Jilin, China, 130012