Esophageal Varices Secondary to Cirrhosis of Liver
Conditions
Brief summary
The main complications of cirrhosis are ascites, esophageal varices and hepatic encephalopathy. About 30% to 70% patients with cirrhosis occur esophageal varices, and the most common complication is ascites. Somatostatin is used to treat esophageal for a long time, otherwise it could aslo prevent ascites. In the study, the investigators explore the effects of somatostatin on post-endoscopic portal hemodynamic in cirrhotic patients with esophageal gastric varices.
Detailed description
126 patients will be enrolled in the study, 63 subjects will be randomized into the group A and the other will be into the group B. Group A: endoscopic therapy and somatostatin treatment. Group B: endoscopic therapy.
Interventions
DRUGSomatostatin
giving stilamin 250ug/h after endoscopic therapy for 5 days
PROCEDUREendoscopic therapy
gastroscope plus EIS/EVL/HI
Sponsors
Yunsheng Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Cirrhosis with esophageal gastric varices needed endoscopic therapy * Age 18-75 years * Informed written consent
Exclusion criteria
* Use of vasoactive drugs 24 hours before endoscopic treatment * Use of B-blocker within 1 week * Previous surgical or endoscopic treatment for esophageal gastric varices * Hepatic encephalopathy,comatose status and any other disease which could not accept endoscopic therapy * Gastro-renal vein shunt * Severe hepatic hydrothorax * Hepatocellular carcinoma with portal vein thrombosis * Severe coagulation disorders * Severe active bacteria infection * Severe cardiovascular disease, including a history of acute myocardial infarction,heart block, heart failure * Severe renal function insufficiency （Calculated Creatinine Clearance Rate (Ccr) \<30ml/min） * Severe co-morbidity that would affect short-term prognosis * Pregnancy or lactation * Allergy to any ingredient of trial medication * Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Portal vein blood flow volume | change from baseline in portal vein blood flow volume after 7 days treatment | Note: 1. Portal vein blood flow volume will be measured by doppler ultrasound device. 2. Values are the mean of three consecutive measurements. 3. Frequency: PVF will be measured on baseline, day1, day 5 and day 7. 4. All doppler studies will be carried out by a single experienced examiner who will be blinded to patient allocation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Portal vein diameter (PVD mm) | change from baseline in PDV after 7 days treatment | Portal vein diameter will be measured by doppler ultrasound device. |
| Mean portal vein blood velocity (PVV cm/s) | change from baseline in PVV after 7 days treatment | PVV will be measured by doppler ultrasound device. |
| Ascites volume | change from baseline after 7 days treatment | Sonography detecting site: the middle point of the line between navel and the right side of anterior superior iliac spine(ASIS) |
Countries
China
Outcome results
None listed