Clinical trial NCT01426087: Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
Official title: Investigator Sponsored Study of Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Varices Secondary to Cirrhosis of Liver
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2011-08-31
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Portal vein blood flow volume
timeFrame: change from baseline in portal vein blood flow volume after 7 days treatment
Secondary outcomes:
measure: Portal vein diameter (PVD mm)
timeFrame: change from baseline in PDV after 7 days treatment
measure: Mean portal vein blood velocity (PVV cm/s)
timeFrame: change from baseline in PVV after 7 days treatment
measure: Ascites volume
timeFrame: change from baseline after 7 days treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Site
Study officials:
affiliation: Chinese PLA General Hospital
name: Yun Sh Yang, Pro.
role: PRINCIPAL_INVESTIGATOR
References: