Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
|ClinicalTrials.gov Identifier: NCT01426087|
Recruitment Status : Unknown
Verified August 2011 by Yunsheng Yang, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : August 31, 2011
Last Update Posted : September 2, 2011
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Varices Secondary to Cirrhosis of Liver||Drug: Somatostatin Procedure: endoscopic therapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|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 :||July 2011|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||December 2012|
U.S. FDA Resources
|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
- Portal vein blood flow volume [ Time Frame: change from baseline in portal vein blood flow volume after 7 days treatment ]
- 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 ]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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|