Effect of preoperative CT angiography examination on the clinical outcome of patients with BMI ≥ 25.0 kg/m2 undergoing laparoscopic gastrectomy: study protocol for a multicentre randomized controlled trial

Cheng Meng, Shougen Cao, Xiaodong Liu, Leping Li, Qingsi He, Lijian Xia, Lixin Jiang, Xianqun Chu, Xinjian Wang, Hao Wang, Xizeng Hui, Zuocheng Sun, Shusheng Huang, Quanhong Duan, Daogui Yang, Huanhu Zhang, Yulong Tian, Zequn Li, Yanbing Zhou, Cheng Meng, Shougen Cao, Xiaodong Liu, Leping Li, Qingsi He, Lijian Xia, Lixin Jiang, Xianqun Chu, Xinjian Wang, Hao Wang, Xizeng Hui, Zuocheng Sun, Shusheng Huang, Quanhong Duan, Daogui Yang, Huanhu Zhang, Yulong Tian, Zequn Li, Yanbing Zhou

Abstract

Background: Gastric cancer, which is the fifth most common malignancy and the third most common cause of cancer-related death, is particularly predominant in East Asian countries, such as China, Japan and Korea. It is a serious global health issue that causes a heavy financial burden for the government and family. To our knowledge, there are few reports of multicentre randomized controlled trials on the utilization of CT angiography (CTA) for patients who are histologically diagnosed with gastric cancer before surgery. Therefore, we planned this RCT to verify whether the utilization of CTA can change the short- and long-term clinical outcomes.

Method: The GISSG 20-01 study is a multicentre, prospective, open-label clinical study that emphasises the application of CTA for patients who will undergo laparoscopic gastrectomy to prove its clinical findings. A total of 382 patients who meet the inclusion criteria will be recruited for the study and randomly divided into two groups in a 1:1 ratio: the CTA group (n = 191) and the non-CTA group (n = 191). Both groups will undergo upper abdomen enhanced CT, and the CTA group will also receive CT angiography. The primary endpoint of this trial is the volume of blood loss. The second primary endpoints are the number of retrieved lymph nodes, postoperative recovery course, hospitalization costs, length of hospitalization days, postoperative complications, 3-year OS and 3-year DFS.

Discussion: It is anticipated that the results of this trial will provide high-level evidence and have clinical value for the application of CTA in laparoscopic gastrectomy.

Trial registration: ClinicalTrials.gov , NCT04636099. Registered November 19, 2020.

Keywords: CTA; Clinical outcomes; Gastric cancer; Laparoscopic gastrectomy; Randomized controlled trial; Study protocol.

Conflict of interest statement

The authors declare that there are no conflicts of interest among each other.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study flowchart. CTA, CT angiography
Fig. 2
Fig. 2
The items of enrolment, interventions and assessments in the flowchart. The symbol of × represent that the program needs to be collected. −1, 2 weeks before operation; 0, perioperation; 1, postoperative adjuvant chemotherapy time; follow-up 2~10 refers to time points that listed in the following: 2, 1 months after surgery; 3, 3 months after surgery; 4, 6 months after surgery; 5, 9 months after surgery; 6, 12 months after surgery; 7, 18 months after surgery; 8, 24 months after surgery; 9, 30 months after surgery; 10, 36 months after surgery

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