Clinical trial NCT02119884: Hemodynamic Effects of Terlipressin and High Dose Octreotide
Official title: Hemodynamic Effects of Terlipressin and High Dose Octreotide on Patients With Liver Cirrhosis Related Esophageal Varices: A Randomized, Placebo-controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric and Esophageal Varices
Keywords: Gastric and Esophageal Varices
Hepatic Venous Pressure Gradient
Terlipressin
Octreotide
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
First posted: 2014-04-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to find patients's response to terlipressin and octreotide during hepatic venous pressure gradient measurement by observing portal and systemic hemodynamics.

Detailed description: Esophageal variceal bleeding is one of the main causes of death in cirrhosis patients. Prevention of bleeding events, including primary and secondary prophylaxis, is very important for reducing the mortality of variceal bleeding. Terlipressin and octreotide can effectively control bleeding with few side effects, which has been recommended by Baveno V in treatment of acute variceal bleeding. Terlipressin and high dose octreotide will be administered to the patients with cirrhosis related esophageal varices when they undergo hepatic venous pressure gradient measurement. Changes from portal and systemic hemodynamics will be observed to evaluate the safety and effects of terlipressin and high dose octreotide as well as to determine wether patients respond to them. The results can be served as clinical evidence for preventing re-bleeding through long-acting terlipressin and octreotide in the future.

Eligibility criteria: Inclusion Criteria:

* Gastric and Esophageal Varices have been confirmed through endoscopy
* Liver Biopsy, CT or MRI indicates cirrhosis
* Patients who experienced variceal bleeding

Exclusion Criteria:

* The patients who are beyond the range from 18 to 80 years old
* The patients with unstable vital signs
* The patients with spontaneous peritonitis or other severe infections
* The patients with hepatorenal syndrome or renal inadequacy
* The patients with uncontrolled hepatic encephalopathy
* Pregnant and lactating women
* The patients who had contraindications for terlipressin or octreotide
* The patients who refuse to take part in this study

Primary outcomes:
measure: Fluctuation of HVPG
timeFrame: 10min, 20min and 30min after administration
Secondary outcomes:
measure: Response Rate
timeFrame: 10min, 20min and 30min after administration
Other outcomes:
measure: Fluctuation of MAP and HR
timeFrame: 10min, 20min and 30min after administration
measure: Incidence rate of complications
timeFrame: Participants will be followed for up to 24h starting from the moment of administration
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Shiyao Chen, Professor
role: STUDY_DIRECTOR
References:
citation: Li B, Chen J, Zhang CQ, Wang GC, Hu JH, Luo JJ, Zhang W, Wei YC, Zeng XQ, Chen SY. The pharmacodynamic effect of terlipressin versus high-dose octreotide in reducing hepatic venous pressure gradient: a randomized controlled trial. Ann Transl Med. 2021 May;9(9):793. doi: 10.21037/atm-20-6774.