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

Yunsheng Yang

Status: Unknown

Conditions: Esophageal Varices Secondary to Cirrhosis of Liver

Treatments: Procedure: endoscopic therapy; Drug: Somatostatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01426087

0105467801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

126 participants in 2 patient groups

endoscopic and somatostatin treatment

Experimental group

Treatment:

Drug: Somatostatin

endoscopic therapy

Other group

Treatment:

Procedure: endoscopic therapy