Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|