Detecting tumor cells during robotic surgery for gastric cancer
Quantitative Detection of CEA mRNA in the Smog and Tissue Exudate Whole Process Collected During Laparoscopic (Robotic) Radical Gastrectomy in Gastric Cancer Patients: Study Protocol for a Single Center Prospective, Single-arm, Longitudinal Pilot Study（SMOG 01Study）
This study looks at whether robotic surgery for stomach cancer might accidentally spread cancer cells and aims to find ways to prevent that from happening.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Affiliated Hospital of Qingdao University Academic / other |
| Locations | 1 site (Qingdao, Shandong) |
| Trial ID | NCT06076265 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the potential for tumor cell dissemination during laparoscopic (robotic) radical gastrectomy in patients with gastric cancer. It focuses on collecting smog and tissue exudates generated throughout the surgical process to assess whether laparoscopic surgery may inadvertently spread cancer cells. Using RT-PCR to detect CEA mRNA, the study seeks to uncover mechanisms behind peritoneal metastasis and propose preventive measures. The research addresses a gap in existing literature regarding the safety of laparoscopic techniques in cancer surgeries.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed gastric adenocarcinoma who are scheduled for laparoscopic or robotic radical gastrectomy.
Not a fit: Patients requiring urgent surgery due to complications or those with extensive peritoneal metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that minimize the risk of cancer cell spread during gastric cancer surgeries.
How similar studies have performed: While there is limited research specifically on this approach, studies on cytological monitoring during surgeries have shown varying degrees of success in understanding tumor spread.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gastric adenocarcinoma confirmed by preoperative pathology * Endoscopic and CT/MRI enhanced examination confirmed that cT1-4aN0-3M0 has the possibility of resection * To undergo radical gastrectomy (laparoscopic or robotic) under general anesthesia+/- epidural anesthesia (carbon dioxide pneumoperitoneum) * Willing and able to comply with the research protocol * Reach a written consent agreement before registration, and fully realize the right to withdraw from the study at any time without any loss Exclusion Criteria: * Urgent surgery is required due to tumor emergencies (such as bleeding, perforation, and obstruction) * Extensive peritoneal metastasis can be seen during intraoperative exploration * Other diseases requiring simultaneous surgery * Patients with ascites * Pregnancy
Where this trial is running
Qingdao, Shandong
- The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Zhou Yanbing, MD
- Email: zhouyanbing@qduhospital.cn
- Phone: 86532-82911324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.