Functional MRI-based Assessment of Terlipressin vs. Octreotide on Renal Function in Cirrhotic Patients With Acute Variceal Bleeding (CHESS1903)

• Status: Recruiting
• Trial end date: 2022-10-15
• Target enrollment: 0
• Participant gender: All

Summary

Acute variceal bleeding is one of the critical complications in patients with cirrhosis. Due to remarkable improvements in diagnostic and therapeutic modalities such as vasoactive agents, endoscopic therapy and antibiotics, the overall prognosis has been improved during the past several decades. However, it is still associated with increased mortality that is still around 20% at 6 weeks.

Patients with advanced cirrhosis have an intense overactivity of the endogenous vasoactive systems characterized by arterial hypotension and low peripheral vascular resistance. Severe renal vasoconstriction in consequence of marked arterial vasodilatation in splanchnic circulation triggers the reduction of glomerular filtration rate, and thus induces acute kidney injury (AKI)/hepatorenal syndrome (HRS), which have been further implicated in the increasing mortality in patients with cirrhosis.

Renal functional magnetic resonance imaging (fMRI), a technique considered superior to the most common method used to estimate the glomerular filtration rate, allows for non-invasive, accurate measurements of renal structures and functions in both animals and humans. It has become increasingly prevalent in research and clinical applications. In recent years, renal fMRI has developed rapidly with progress in MRI hardware and emerging post-processing algorithms. Function related imaging markers could be acquired via renal fMRI, encompassing water molecular diffusion, perfusion, and oxygenation. The study will use phase contrast - MR angiography, intravoxel incoherent motion - diffusion weighted imaging (IVIM-DWI) and blood-oxgen-level-dependent (BOLD)-MRI to evaluate renal functional changes after using vasoactive medications in patients with cirrhosis.

The rationale for the use of vasoactive medications, including terlipressin and octreotide, is to produce splanchnic vasoconstriction and reduce portal blood flow and portal pressure, thereby underpinning the application of these vasoactive drugs in the management of cirrhotic patients with acute variceal bleeding. Meanwhile, terlipressin has been recommended as the international first-line pharmacological therapy for the treatment of HRS because terlipressin may improve renal hemodynamics, improve renal function and potentially enable HRS a reversible condition without the need of liver transplantation. However, the renal protection effect of terlipressin vs. octreotide remains unknown. In this study, the investigators aim to conduct a multicenter, single-blind randomized controlled trial to compare the renal protection effect of terlipressin vs. octreotide assessed by fMRI in the management of cirrhotic patients with acute variceal bleeding.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Guangdong Second Provincial General Hospital; LanZhou University; the Second Affiliated Hospital of Anhui Medical University; The Second Affiliated Hospital of Baotou Medical College; The Second Affiliated Hospital of Baotou Medical University; The Second Hospital of Anhui Medical University; The Sixth People Hospital of Shenyang; The Sixth People's Hospital of Shenyang; The Third Hospital of Zhenjiang Affiliated Jiangsu University; Tianjin Second People's Hospital; Xingtai People's Hospital; Zhongda Hospital, Medical School, Southeast University
• Treatments: Octreotide; Terlipressin

Criteria

Inclusion Criteria:

• clinically and/or pathologically diagnosed cirrhosis

• with a clinical history of acute variceal bleeding (melena, hematemesis etc.) assessed as Child-Pugh class B or C

• voluntarily participated in the study and able to provide written informed consent and able to understand and willing to comply with the requirements of the study

Exclusion Criteria:

• pregnant or lactating woman

• diagnosed or suspected malignancy (hepatocellular carcinoma, cholangiocarcinoma etc.)

• with mental disease and unable to comply with MRI examination

• with contraindications of terlipressin and octreotide

• with other conditions judged inadequate for participation by the investigators.