Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
Recruitment status was Recruiting
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.
Esophageal Varices Secondary to Cirrhosis of Liver
Procedure: endoscopic therapy
|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|
- 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 ]
- 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.
- 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)
|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)|
|Experimental: endoscopic and somatostatin treatment||
giving stilamin 250ug/h after endoscopic therapy for 5 days
Other Name: stilamin
Procedure: endoscopic therapy
gastroscope plus EIS/EVL/HI
Other Name: antisterone,DHCT,albumin or antibiotics
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426087
|Beijing, China, 010|
|Contact: Yun Sh Yang, Pro. 010-66936115|
|Principal Investigator: Yun Sh Yang, Professor|
|Sub-Investigator: Di Yu Yang, Pro.|
|Principal Investigator:||Yun Sh Yang, Pro.||Chinese PLA General Hospital|