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

Primary Purpose

Esophageal Varices Secondary to Cirrhosis of Liver

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Somatostatin
endoscopic therapy
Sponsored by
Yunsheng Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Esophageal Varices Secondary to Cirrhosis of Liver

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cirrhosis with esophageal gastric varices needed endoscopic therapy
  • Age 18-75 years
  • Informed written consent

Exclusion Criteria:

  • Use of vasoactive drugs 24 hours before endoscopic treatment
  • Use of B-blocker within 1 week
  • Previous surgical or endoscopic treatment for esophageal gastric varices
  • Hepatic encephalopathy,comatose status and any other disease which could not accept endoscopic therapy
  • Gastro-renal vein shunt
  • Severe hepatic hydrothorax
  • Hepatocellular carcinoma with portal vein thrombosis
  • Severe coagulation disorders
  • Severe active bacteria infection
  • Severe cardiovascular disease, including a history of acute myocardial infarction,heart block, heart failure
  • Severe renal function insufficiency (Calculated Creatinine Clearance Rate (Ccr) <30ml/min)
  • Severe co-morbidity that would affect short-term prognosis
  • Pregnancy or lactation
  • Allergy to any ingredient of trial medication
  • Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent

Sites / Locations

  • SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

endoscopic and somatostatin treatment

endoscopic therapy

Arm Description

Outcomes

Primary Outcome Measures

Portal vein blood flow volume
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.

Secondary Outcome Measures

Portal vein diameter (PVD mm)
Portal vein diameter will be measured by doppler ultrasound device.
Mean portal vein blood velocity (PVV cm/s)
PVV will be measured by doppler ultrasound device.
Ascites volume
Sonography detecting site: the middle point of the line between navel and the right side of anterior superior iliac spine(ASIS)

Full Information

First Posted
August 29, 2011
Last Updated
August 31, 2011
Sponsor
Yunsheng Yang
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1. Study Identification

Unique Protocol Identification Number
NCT01426087
Brief Title
Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
Official Title
Investigator Sponsored Study of Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yunsheng Yang

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Varices Secondary to Cirrhosis of Liver

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endoscopic and somatostatin treatment
Arm Type
Experimental
Arm Title
endoscopic therapy
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Somatostatin
Other Intervention Name(s)
stilamin
Intervention Description
giving stilamin 250ug/h after endoscopic therapy for 5 days
Intervention Type
Procedure
Intervention Name(s)
endoscopic therapy
Other Intervention Name(s)
antisterone,DHCT,albumin or antibiotics
Intervention Description
gastroscope plus EIS/EVL/HI
Primary Outcome Measure Information:
Title
Portal vein blood flow volume
Description
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.
Time Frame
change from baseline in portal vein blood flow volume after 7 days treatment
Secondary Outcome Measure Information:
Title
Portal vein diameter (PVD mm)
Description
Portal vein diameter will be measured by doppler ultrasound device.
Time Frame
change from baseline in PDV after 7 days treatment
Title
Mean portal vein blood velocity (PVV cm/s)
Description
PVV will be measured by doppler ultrasound device.
Time Frame
change from baseline in PVV after 7 days treatment
Title
Ascites volume
Description
Sonography detecting site: the middle point of the line between navel and the right side of anterior superior iliac spine(ASIS)
Time Frame
change from baseline after 7 days treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cirrhosis with esophageal gastric varices needed endoscopic therapy Age 18-75 years Informed written consent Exclusion Criteria: Use of vasoactive drugs 24 hours before endoscopic treatment Use of B-blocker within 1 week Previous surgical or endoscopic treatment for esophageal gastric varices Hepatic encephalopathy,comatose status and any other disease which could not accept endoscopic therapy Gastro-renal vein shunt Severe hepatic hydrothorax Hepatocellular carcinoma with portal vein thrombosis Severe coagulation disorders Severe active bacteria infection Severe cardiovascular disease, including a history of acute myocardial infarction,heart block, heart failure Severe renal function insufficiency (Calculated Creatinine Clearance Rate (Ccr) <30ml/min) Severe co-morbidity that would affect short-term prognosis Pregnancy or lactation Allergy to any ingredient of trial medication Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Sh Yang, Pro.
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site
City
Beijing
ZIP/Postal Code
010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Sh Yang, Pro.
Phone
010-66936115
First Name & Middle Initial & Last Name & Degree
Yun Sh Yang, Professor
First Name & Middle Initial & Last Name & Degree
Di Yu Yang, Pro.

12. IPD Sharing Statement

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

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