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Trial Title:
Quantitative Detection of CEA mRNA in the Smog and Tissue Exudate Whole Process Collected During Laparoscopic (Robotic) Radical Gastrectomy in Gastric Cancer Patients
NCT ID:
NCT06076265
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Advanced Gastric Cancer
Laparoscopic(Robotic) Gastrectomy
RT-PCR
CEA
Free intraperitoneal tumor cells
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Radical Gastric Cancer Surgery
Description:
Laparoscopic (robotic) radical surgery for gastric cancer
Arm group label:
Single arm group
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.
Criteria for eligibility:
Study pop:
Gastric cancer patients over 18 years old who plan to undergo radical gastrectomy for
gastric cancer
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhou Yanbing, MD
Phone:
86532-82911324
Email:
zhouyanbing@qduhospital.cn
Contact backup:
Last name:
Zhang Peng, MM
Phone:
86532-17854217082
Email:
zzzp15171088311@163.com
Start date:
December 1, 2022
Completion date:
October 2023
Lead sponsor:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Source:
The Affiliated Hospital of Qingdao University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06076265
