Gastric and Esophageal Varices
Conditions
Keywords
Gastric and Esophageal Varices, Hepatic Venous Pressure Gradient, Terlipressin, Octreotide
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.
Interventions
DRUGTerlipressin
Patients in the terlipressin group receive a single IV injection of 2 mg of terlipressin and a continuous IV infusion of normal saline.
DRUGOctreotide
Patients in high dose octreotide receive a single injection of 100μg octreotide and continuous IV infusion of 50 μg/h of octreotide.
Sponsors
Shandong Provincial Hospital
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluctuation of HVPG | 10min, 20min and 30min after administration | Terlipressin or octreotide will be administered to a patient once after the bottom line of his/her HVPG is determined. We observe the changes of HVPG after administration to find out the effects of terlipressin or octreotide on portal hemodynamics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 10min, 20min and 30min after administration | Patients are considered responders when the HVPG decreases below 20 mmHg or by more than 10% from the baseline value |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fluctuation of MAP and HR | 10min, 20min and 30min after administration | Terlipressin or octreotide will be administered to a patient once after the bottom line of his/her mean arterial pressure and heart rate, as well as HVPG, are determined. We observe the changes of MAP and HR after administration to find out the effects of terlipressin or octreotide on systemic hemodynamics. |
| Incidence rate of complications | Participants will be followed for up to 24h starting from the moment of administration | We intend to set incidence rate of complications associated with terlipressin or octreotide, to be specific, which include hypertension, abdominal pain, nausea, vomiting, diarrhea, headache, transient arrhythmia and vertigo. Participants will be followed for up to 24h starting from the moment of administration. |
Countries
China
Outcome results
None listed