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

Not Applicable

• Conditions: Esophageal Varices Secondary to Cirrhosis of Liver
• Interventions: Procedure: endoscopic therapy; Drug: Somatostatin

• Registration Number: NCT01426087
• Lead Sponsor: Yunsheng Yang

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.

Study Timeline

• Study Start: 2011-07
• Status Verified: 2011-08
• Study First Submitted: 2011-08-29
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-08-31
• Last Update Submitted: 2011-08-31
• Last Update Posted: 2011-09-02
• Primary Completion: 2012-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopic therapy	endoscopic therapy	-
endoscopic and somatostatin treatment	Somatostatin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Site; 🇨🇳 Beijing, China