Background
Gastric cancer, which ranks the fifth most common malignant and causes the third oncological death, especially in east Asian countries, such as China, Japan and Korea, is still a serious global healthy issue that caused heavy financial burden for the government and family. To our knowledge, there is seldom reports of multicenter randomized control trial on the utilization of CT angiography (CTA)for the patients who are diagnosed histological gastric cancer before surgery. Therefore, we conduct this RCT to verify whether the utilization of CTA can possibly change the short- and long-term clinical outcome or not.
Method:
The GISSG 20 − 01 study is a multicenter, prospective, open-lable clinical study that emphasis on the application of the CTA for the patients who will undergo the laparoscopic gastrectomy to prove the clinical outcome of it. 382 patients that meet the inclusion criteria and not in accordance with exclusion criteria will be recruited in the study and randomly divided into two groups with a 1:1 ratio: CTA group(n = 191) and Non-CTA group (n = 191). Apart from both of the two groups receive the examination of upper abdomen enhanced CT, the CTA group receive the examination of CT angiography. The primary endpoint of this trial is the volume of blood loss, the second primary endpoints are retrieved number of lymph nodes, postoperative recovery course, hospitalization costs, length of hospitalization days, postoperative complications, 3 years OS and 3 years DFS.
Discussion
It is anticipated that the result of this trial can provide high-level evidence and have clinical value on the application of CTA in laparoscopic gastrectomy.
Trial registration:
ClinicalTrials.gov, NCT04636099, Registered November 19, 2020