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

Yunsheng Yang126 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

126

Conditions

Esophageal Varices Secondary to Cirrhosis of Liver

Interventions

SomatostatinDRUG

giving stilamin 250ug/h after endoscopic therapy for 5 days

endoscopic therapyPROCEDURE

gastroscope plus EIS/EVL/HI

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Site

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

Portal vein blood flow volume

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.

Time frame: change from baseline in portal vein blood flow volume after 7 days treatment

Secondary Outcomes

Portal vein diameter (PVD mm)

Portal vein diameter will be measured by doppler ultrasound device.

Time frame: 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.

Time frame: 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)

Time frame: change from baseline after 7 days treatment

Data from ClinicalTrials.gov

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