Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigator Sponsored Study of Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices

Conditions
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Esophageal Varices Secondary to Cirrhosis of Liver

Intervention / Treatment
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* Drug: Somatostatin
* Procedure: endoscopic therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endoscopic and somatostatin treatment<br> | Drug: Somatostatin<br>* giving stilamin 250ug/h after endoscopic therapy for 5 days<br>* Other names: stilamin;|
| Other: endoscopic therapy<br> | Procedure: endoscopic therapy<br>* gastroscope plus EIS/EVL/HI<br>* Other names: antisterone,DHCT,albumin or antibiotics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Portal vein blood flow volume | Note: Portal vein blood flow volume will be measured by doppler ultrasound device. Values are the mean of three consecutive measurements. Frequency: PVF will be measured on baseline, day1, day 5 and day 7. All doppler studies will be carried out by a single experienced examiner who will be blinded to patient allocation. | change from baseline in portal vein blood flow volume after 7 days treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Portal vein diameter (PVD mm) | Portal vein diameter will be measured by doppler ultrasound device. | change from baseline in PDV after 7 days treatment | 
| Mean portal vein blood velocity (PVV cm/s) | PVV will be measured by doppler ultrasound device. | change from baseline in PVV after 7 days treatment | 
| Ascites volume | Sonography detecting site: the middle point of the line between navel and the right side of anterior superior iliac spine(ASIS) | change from baseline after 7 days treatment |