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

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ClinicalTrials.gov Identifier: NCT01426087
Recruitment Status : Unknown
Verified August 2011 by Yunsheng Yang, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : August 31, 2011
Last Update Posted : September 2, 2011
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Esophageal Varices Secondary to Cirrhosis of Liver Drug: Somatostatin Procedure: endoscopic therapy

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Investigator Sponsored Study of Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
Study Start Date : July 2011
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2012

Arms and Interventions

Arm Intervention/treatment
Experimental: endoscopic and somatostatin treatment Drug: Somatostatin
giving stilamin 250ug/h after endoscopic therapy for 5 days
Other Name: stilamin
endoscopic therapy Procedure: endoscopic therapy
gastroscope plus EIS/EVL/HI
Other Name: antisterone,DHCT,albumin or antibiotics

Outcome Measures

Primary Outcome Measures :
  1. Portal vein blood flow volume [ Time Frame: change from baseline in portal vein blood flow volume after 7 days treatment ]


    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 :
  1. Portal vein diameter (PVD mm) [ Time Frame: change from baseline in PDV after 7 days treatment ]
    Portal vein diameter will be measured by doppler ultrasound device.

  2. Mean portal vein blood velocity (PVV cm/s) [ Time Frame: change from baseline in PVV after 7 days treatment ]
    PVV will be measured by doppler ultrasound device.

  3. Ascites volume [ Time Frame: 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)

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426087

Site Recruiting
Beijing, China, 010
Contact: Yun Sh Yang, Pro.    010-66936115      
Principal Investigator: Yun Sh Yang, Professor         
Sub-Investigator: Di Yu Yang, Pro.         
Sponsors and Collaborators
Yunsheng Yang
Principal Investigator: Yun Sh Yang, Pro. Chinese PLA General Hospital
More Information

Responsible Party: Yunsheng Yang, chinese PLA General Hospital, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01426087     History of Changes
Other Study ID Numbers: 0105467801
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Varicose Veins
Esophageal and Gastric Varices
Liver Cirrhosis
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs