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:
- 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.
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