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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

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

NCT ID

NCT01426087

First Posted

August 29, 2011

Last Updated

August 31, 2011

Sponsor

Yunsheng Yang

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

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

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

Learn more about this trial

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

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