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

Sponsor
Yunsheng Yang (Other)
Overall Status
Unknown status
CT.gov ID
NCT01426087
Collaborator
(none)
126
Enrollment
1
Location
2
Arms
17.1
Duration (Months)
7.4
Patients Per Site Per Month

Study Details

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 Phase
N/A

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
Anticipated 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 :
Jul 1, 2011
Anticipated Primary Completion Date :
Oct 1, 2012
Anticipated Study Completion Date :
Dec 1, 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 Names:
  • stilamin

    		•
    Other: endoscopic therapy

    Procedure: endoscopic therapy
    gastroscope plus EIS/EVL/HI
    Other Names:
  • antisterone,DHCT,albumin or antibiotics

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Portal vein blood flow volume [change from baseline in portal vein blood flow volume after 7 days treatment]

      Note: Portal vein blood flow volume will be measured by doppler ultrasound device. Values are the mean of three consecutive measurements. Frequency: PVF will be measured on baseline, day1, day 5 and day 7. 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) [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) [change from baseline in PVV after 7 days treatment]

      PVV will be measured by doppler ultrasound device.

    3. Ascites volume [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

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    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

    Locations

    Site City State Country Postal Code
    1 Site Beijing China 010

    Sponsors and Collaborators

    • Yunsheng Yang

    Investigators

    • Principal Investigator: Yun Sh Yang, Pro., Chinese PLA General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yunsheng Yang, chinese PLA General Hospital, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT01426087
    Other Study ID Numbers:
    • 0105467801
    First Posted:
    Aug 31, 2011
    Last Update Posted:
    Sep 2, 2011
    Last Verified:
    Aug 1, 2011
    Additional relevant MeSH terms:
    Esophageal and Gastric Varices
    Liver Cirrhosis
    Varicose Veins
    Anti-Bacterial Agents
    Somatostatin

    Study Results

    No Results Posted as of Sep 2, 2011