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

August 31, 2011 updated by: Yunsheng Yang

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 010
        • Recruiting
        • Site
        • Contact:
          • Yun Sh Yang, Pro.
          • Phone Number: 010-66936115
        • Principal Investigator:
          • Yun Sh Yang, Professor
        • Sub-Investigator:
          • Di Yu Yang, Pro.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: endoscopic and somatostatin treatment
Drug: Somatostatin
giving stilamin 250ug/h after endoscopic therapy for 5 days
Other Names:
  • stilamin
Other: endoscopic therapy
Procedure: endoscopic therapy
gastroscope plus EIS/EVL/HI
Other Names:
  • antisterone,DHCT,albumin or antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Portal vein blood flow volume
Time Frame: change from baseline in portal vein blood flow volume after 7 days treatment

Note:

  1. Portal vein blood flow volume will be measured by doppler ultrasound device.
  2. Values are the mean of three consecutive measurements.
  3. Frequency: PVF will be measured on baseline, day1, day 5 and day 7.
  4. All doppler studies will be carried out by a single experienced examiner who will be blinded to patient allocation.
change from baseline in portal vein blood flow volume after 7 days treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline in PDV after 7 days treatment
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.
change from baseline in PVV after 7 days treatment
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)
change from baseline after 7 days treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yunsheng Yang

Investigators

  • Principal Investigator: Yun Sh Yang, Pro., Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 29, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

August 31, 2011

Study Record Updates

Last Update Posted (Estimate)

September 2, 2011

Last Update Submitted That Met QC Criteria

August 31, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0105467801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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