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

This study is currently recruiting participants.
Verified August 2011 by Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Yunsheng Yang, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01426087
First received: August 29, 2011
Last updated: August 31, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Esophageal Varices Secondary to Cirrhosis of Liver
 Drug: Somatostatin
Procedure: endoscopic therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Portal vein blood flow volume [ Time Frame: change from baseline in portal vein blood flow volume after 7 days treatment ] [ Designated as safety issue: Yes ]

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

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

  • Ascites volume [ Time Frame: change from baseline after 7 days treatment ] [ Designated as safety issue: Yes ]
    Sonography detecting site: the middle point of the line between navel and the right side of anterior superior iliac spine(ASIS)


Estimated Enrollment: 126
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426087

Locations
China
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
Investigators
Principal Investigator: Yun Sh Yang, Pro. Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: Yunsheng Yang, chinese PLA General Hospital, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01426087     History of Changes
Other Study ID Numbers: 0105467801
Study First Received: August 29, 2011
Last Updated: August 31, 2011
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Esophageal Diseases
Fibrosis
Liver Cirrhosis
Varicose Veins
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Pathologic Processes
 Vascular Diseases
Cardiovascular Diseases
Anti-Bacterial Agents
Somatostatin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013