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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Esophageal Varices Secondary to Cirrhosis of Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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endoscopic and somatostatin treatment

Group Type EXPERIMENTAL

Somatostatin

Intervention Type DRUG

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

endoscopic therapy

Group Type OTHER

endoscopic therapy

Intervention Type PROCEDURE

gastroscope plus EIS/EVL/HI

Interventions

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Somatostatin

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

Intervention Type DRUG

endoscopic therapy

gastroscope plus EIS/EVL/HI

Intervention Type PROCEDURE

Other Intervention Names

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stilamin antisterone,DHCT,albumin or antibiotics

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No