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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Investigator Sponsored Study of Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices

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 Summary:

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.


Sponsor: Yunsheng Yang

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

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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)


Original Secondary Outcome: Same as current

Information By: Chinese PLA General Hospital

Dates:
Date Received: August 29, 2011
Date Started: July 2011
Date Completion: December 2012
Last Updated: August 31, 2011
Last Verified: August 2011