Endoscopic variceal ligation combined with carvedilol versus endoscopic variceal ligation combined with propranolol for the treatment of oesophageal variceal bleeding in cirrhosis: study protocol for a multicentre, randomised controlled trial.
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Li Yiling, Du Li, Zhang Shuairan, Liu Chuan, Ma Chao, Liu Xiaochao, Xu Huanhai, Fan Zhixu, Hu Shengjuan, Wang Jing, Shao Lichun, Peng Lijun, Xiang Huiling, Liang Xuan, Zhang Wenhui, Zhao Hongyun, He Pengyuan, Xu Jingyi, Li Qianlong, Yang Ling, Wu Yunhai, Zhang Liyao, Fang Dianliang, Ye Hua, Zhang Liwei, Zhang Li, Zhang Xiaojie, Wei Zhi, Peng Ya, Pan Qinghua, Li Quanke, Xu Jing, Xia Dongli, Lv Yuchen, Zhang Zongchao, Yan Chaoguang, Wang Jian, Wan Yuxia, Xie Biao, Fang Haiming, Yang Wenlong, Yan Wei, Chen Yi, Zhang Shaoting, Zhang Xiangman, Rao Wei, Xia Xiurong, Qiao Qiang, Yu Ruimiao, Ren Changzhen, Song Ying, Yang Yuejun, Li Jianzhou, Wang Lei, Zhai Zhenzhen, Liu Xuejin, Lu Xingjun, Li Meng, Jia Yansheng, Wang Rong, Wang Duolao, Cardenas Andres, Jin Zhendong, Qi Xiaolong
Аннотация
METHODS AND ANALYSIS: This multicentre, RCT is scheduled to begin in December 2024, with recruitment and follow-up continuing until December 2026. Eligible participants are patients with liver cirrhosis and EVB. Participants are randomly assigned in a 1:1 ratio to receive EVL combined with either carvedilol or propranolol. The primary endpoint is the incidence of variceal rebleeding or all-cause death. Secondary endpoints include all-cause death, liver-related death, each of the complications of portal hypertension (overt ascites, overt hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorenal syndrome, portal vein thrombosis), hepatocellular carcinoma, changes in liver function (assessed by Child-Pugh and Model for End-Stage Liver Disease scores), changes in liver stiffness, changes in spleen stiffness, and adverse events. Subgroup and sensitivity analyses will be conducted to evaluate the consistency and robustness of the treatment effects. A total sample size of 524 patients (262 per group) is required to detect a significant difference between the treatment arms.
ETHICS AND DISSEMINATION: The study protocol has been approved by the ethics committee of the First Hospital of China Medical University (No. 2024-656-2). The study will follow the Declaration of Helsinki and Good Clinical Practice guidelines. The findings of this trial will be disseminated through peer-reviewed publications, conference presentations and healthcare professionals to guide future clinical practice.
TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry (Registration number: ChiCTR2400089692).