Esophageal Varices Secondary to Cirrhosis of Liver Clinical Trial
Official title:
Investigator Sponsored Study of Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
| Verified date | August 2011 |
| Source | Chinese PLA General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Ethics Committee |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 126 |
| Est. completion date | December 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| China | Site | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Yunsheng Yang |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | Portal vein diameter (PVD mm) | Portal vein diameter will be measured by doppler ultrasound device. | change from baseline in PDV after 7 days treatment | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |