Quantitative Detection of CEA mRNA in the Smog and Tissue Exudate Whole Process Collected During Laparoscopic (Robotic) Radical Gastrectomy in Gastric Cancer Patients

Recruiting

• Conditions: Gastric Cancer
• Interventions: Procedure: Radical Gastric Cancer Surgery

• Registration Number: NCT06076265
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

The purpose of this SMOG 01 study is to observe the possibility of intraperitoneal dissemination of tumor cells throughout the entire laparoscopic (robotic) radical gastrectomy for gastric cancer and explore its related mechanisms and potential clinical significance with peritoneal metastasis.

Detailed Description

Cytological examination of peritoneal lavage fluid has become an important parameter for pathological staging and prognosis judgment of gastric cancer. However, the vast majority of previous studies have only focused on collecting peritoneal lavage fluid through laparotomy or laparoscopic exploration for cytological and tumor marker monitoring as further tumor staging. Unfortunately, there is no research focusing on whether laparoscopic (or robotic) surgery under the carbon dioxide pneumoperitoneum environment can cause the iatrogenic spread of cancer cells, and there is also a lack of a practical and feasible method to collect smog and tissue exudates generated throughout the entire surgical process for cytological monitoring, to determine whether laparoscopic surgery itself may cause the iatrogenic spread of tumor cell, to uncover the potential mechanisms and propose appropriate preventive measures of peritoneal metastasis. Therefore, the investigators have designed a special device to collect smog and tissue exudates generated during laparoscopic or robotic radical gastrectomy to determine whether there is a possibility of iatrogenic cancer cell dissemination in the abdominal cavity throughout the entire course of laparoscopic or robotic surgery by using RT-PCR to detect CEA mRNA, which can become one of the reasons for gastric cancer peritoneal metastasis.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-09-20
• Status Verified: 2023-10
• Primary Completion: 2023-10
• Study Completion: 2023-10
• Study First Submitted QC: 2023-10-07
• Last Update Submitted: 2023-10-07
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm group	Radical Gastric Cancer Surgery	-

Primary Outcome Measures

Name	Time	Method
Positive detection rate of CEA	Supervision of the whole operation: collection of peritoneal lavage fluid at three time points, before the start of the operation, during the operation, and at the end of the operation	Positive detection rate of CEA

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China