Functional magnetic resonance imaging-based assessment of terlipressin vs. octreotide on renal function in cirrhotic patients with acute variceal bleeding (CHESS1903): study protocol of a multicenter randomized controlled trial

Xinwen Yan; Ruoyang Shao; Yuancheng Wang; Xiaorong Mao; Junqiang Lei; Liting Zhang; Jianjun Zheng; Aimin Liu; Huimin Zhao; Fengxiao Gao; Jitao Wang; Ping Li; Shengjuan Yao; Ming Xu; Jian Xu; Dengxiang Liu; Yuqiang Mi; Xijun Gong; Jun Ye; Mingming Deng; Tong Dang; Jiansong Ji; Chuxiao Shao; Chao Liu; Ye Gu; Yunhong Wu; Fengmei Wang; Gaojun Teng; Xun Li; Xingshun Qi; Shenghong Ju; Xiaolong Qi

doi:10.21037/atm.2019.09.141

Functional magnetic resonance imaging-based assessment of terlipressin vs. octreotide on renal function in cirrhotic patients with acute variceal bleeding (CHESS1903): study protocol of a multicenter randomized controlled trial

Ann Transl Med. 2019 Oct;7(20):586. doi: 10.21037/atm.2019.09.141.

Authors

Xinwen Yan^{1

2}, Ruoyang Shao^{1

2}, Yuancheng Wang³, Xiaorong Mao¹, Junqiang Lei¹, Liting Zhang¹, Jianjun Zheng⁴, Aimin Liu⁵, Huimin Zhao⁶, Fengxiao Gao⁶, Jitao Wang⁶, Ping Li⁷, Shengjuan Yao⁷, Ming Xu⁸, Jian Xu⁹, Dengxiang Liu⁶, Yuqiang Mi⁷, Xijun Gong¹⁰, Jun Ye¹¹, Mingming Deng¹², Tong Dang¹³, Jiansong Ji¹⁴, Chuxiao Shao¹⁵, Chao Liu¹⁶, Ye Gu¹⁷, Yunhong Wu¹⁶, Fengmei Wang⁷, Gaojun Teng¹⁸, Xun Li¹, Xingshun Qi¹⁹, Shenghong Ju³, Xiaolong Qi¹

Affiliations

¹ CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou 730000, China.
² Department of Hepatology Unit and Infectious Diseases, The First School of Clinical Medicine, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.
³ Department of Radiology, Zhongda Hospital, Medical School of Southeast University, Nanjing 210009, China.
⁴ Department of Radiology, Hwa Mei Hospital, University of Chinese Academy of Sciences, Ningbo 315010, China.
⁵ Department of Gastroenterology, Fuling Central Hospital of Chongqing City, Chongqing 404000, China.
⁶ CHESS Working Party, Xingtai People's Hospital, Xingtai 054031, China.
⁷ CHESS Working Party, Tianjin Second People's Hospital, Tianjin 300192, China.
⁸ Department of Gastroenterology, Guangdong Second Provincial General Hospital, Guangzhou 510317, China.
⁹ Department of Hepatology & Translation Medicine, Fuling Center Hospital of Chongqing City, Chongqing 404000, China.
¹⁰ Department of Radiology, The Second Affiliated Hospital of Anhui Medical University, Hefei 230601, China.
¹¹ Department of Hepatology, The Second Affiliated Hospital of Anhui Medical University, Hefei 230601, China.
¹² Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.
¹³ Inner Mongolia Institute of Digestive Diseases, The Second Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou 014040, China.
¹⁴ Key Laboratory of Imaging Diagnosis and Minimally Invasive Intervention Research, The Fifth Affiliated Hospital of Wenzhou Medical University, Affiliated Lishui Hospital of Zhejiang University, The Central Hospital of Zhejiang Lishui, Lishui 323000, China.
¹⁵ Department of Hepatobiliary and Pancreatic Surgery, The Fifth Affiliated Hospital of Wenzhou Medical University, Affiliated Lishui Hospital of Zhejiang University, The Central Hospital of Zhejiang Lishui, Lishui 323000, China.
¹⁶ CHESS Working Party, Hospital of Chengdu Office, People's Government of Tibet Autonomous Region, Chengdu 610041, China.
¹⁷ Department of Gastroenterology, The Sixth Peoples Hospital of Shenyang, Shenyang 110006, China.
¹⁸ Department of Interventional Radiology, Zhongda Hospital, Medical School of Southeast University, Nanjing 210009, China.
¹⁹ Liver Cirrhosis Study Group, Department of Gastroenterology, General Hospital of Shenyang Military Area, Shenyang 110000, China.

Abstract

Background: Acute variceal bleeding is one of the critical complications in patients with liver cirrhosis. Severe renal vasoconstriction in consequence of low peripheral vascular resistance triggers the reduction of glomerular filtration rate (GFR), and thus induces acute kidney injury (AKI)/hepato-renal syndrome (HRS). Terlipressin and octreotide have been used in the management of cirrhotic patients with variceal bleeding. Also, terlipressin has been recommended as the international first-line pharmacological therapy for the treatment of HRS. In addition, the use of renal functional magnetic resonance imaging (fMRI) has become increasingly prevalent in research and clinical applications. However, the renal function-protective effect of terlipressin and octreotide and the value of fMRI in monitoring renal function remains unclear in patients with cirrhosis undergoing acute variceal bleeding.

Methods: This is a multicenter, randomized controlled trial (RCT). Participants will be 1:1 assigned randomly into either terlipressin or octreotide groups. Sixty participants with clinically and/or pathologically diagnosed cirrhosis and active gastroesophageal variceal bleeding (GVB) will be recruited in several sites in China. Participants will receive either the treatment of terlipressin or octreotide after assigned into each group. The primary end point for the trial is the renal function. The secondary end points are (I) renal perfusion; (II) renal blood oxygenation; (III) failure to control bleeding; (IV) intra-hospital rebleeding; (V) intra-hospital mortality; (VI) adverse events (AE); (VII) overall survival. Statistical analysis including multivariate Cox regression, Kaplan-Meier analysis with log-rank test, etc. will be conducted.

Discussion: The study will provide new insight into the protection of renal function in the process of the treatment of variceal bleeding in patients with cirrhosis.

Trial registration number: NCT04028323.

Keywords: Hemorrhage; cirrhosis; functional magnetic resonance imaging (fMRI); octreotide; terlipressin.

Associated data

ClinicalTrials.gov/NCT04028323