Effect of preoperative CT angiography examination on the clinical outcome of patients with BMI ≥ 25.0 kg/m 2 undergoing laparoscopic gastrectomy: study protocol for a multicentre randomized controlled trial.

Autor: Meng C; Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, China., Cao S; Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, China., Liu X; Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, China., Li L; Department of Gastrointestinal Surgery, Shandong Provincial Hospital, Jinan, China., He Q; Department of Gastrointestinal Surgery, Qilu Hospital of Shandong University, Jinan, China., Xia L; Department of Gastrointestinal Surgery, Qianfoshan Hospital of Shandong Province, Jinan, China., Jiang L; Department of Gastrointestinal Surgery, Yantai Yuhuangding Hospital, Yantai, China., Chu X; Department of Gastrointestinal Surgery, Jining No.1 People's Hospital, Jining, China., Wang X; Department of Gastrointestinal Surgery, Weihai Central Hospital, Weihai, China., Wang H; Department of Gastrointestinal Surgery, Dongying People's Hospital, Dongying, China., Hui X; Department of Gastrointestinal Surgery, Rizhao People's Hospital, Rizhao, China., Sun Z; Department of Oncological Surgery, Weifang People's Hospital, Weifang, China., Huang S; Department of Gastrointestinal Surgery, People's Hospital of Jimo District, Qingdao, China., Duan Q; Department of Gastrointestinal Surgery, Affiliated Hospital of Weifang Medical University, Weifang, China., Yang D; Department of Gastrointestinal Surgery, Liaocheng People's Hospital, Liaocheng, China., Zhang H; Department of Gastrointestinal Surgery, Weihai Municipal Hospital, Weihai, China., Tian Y; Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, China., Li Z; Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, China., Zhou Y; Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, China. zhouyanbing999@aliyun.com.
Jazyk: angličtina
Zdroj: Trials [Trials] 2021 Dec 11; Vol. 22 (1), pp. 912. Date of Electronic Publication: 2021 Dec 11.
DOI: 10.1186/s13063-021-05887-1
Abstrakt: 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.
(© 2021. The Author(s).)
Databáze: MEDLINE
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