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The Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices

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ClinicalTrials.gov Identifier: NCT03171805
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
luo xuefeng, West China Hospital

Brief Summary:
Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to manage gastric varices. However, more than one third of patients after BRTO treatment experienced worsening of esophageal varices. The present study was designed to evaluate the effect of post-BRTO propranolol adminstration on the change of esophageal varices.

Condition or disease Intervention/treatment Phase
Liver Cirrhoses Portal Hypertension Gastric Varix Drug: Propranolol Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-balloon Occluded Retrograde Transvenous Obliteration Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 15, 2018
Estimated Study Completion Date : December 30, 2020


Arm Intervention/treatment
Experimental: Propranolol group
Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.
Drug: Propranolol
Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.

No Intervention: control group
Propranolol was not given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.



Primary Outcome Measures :
  1. Worsening of esophageal varices rate [ Time Frame: 3 years ]
    Analysis


Secondary Outcome Measures :
  1. Variceal rebleeding rate [ Time Frame: 3 years ]
    Analysis

  2. Mortality rate [ Time Frame: 3 years ]
    Analysis

  3. Worsening of ascites rate [ Time Frame: 3 years ]
    Analysis



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of liver cirrhosis
  2. Clinical diagnosis of isolated gastric varices
  3. The presenec of spontaneous portosystemic shunt

Exclusion Criteria:

  1. Contradictions to Propranolol
  2. Balloon occluded retrograde transvenous obliteration was failed

Information from the National Library of Medicine

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): NCT03171805


Contacts
Contact: xuefeng luo 02885422311 luo_xuefeng@yeah.net

Locations
China
West china Hospital Recruiting
Chengdu, China
Contact: xuefeng luo    02885422311    luo_xuefeng@yeah.net   
Sponsors and Collaborators
West China Hospital
Investigators
Principal Investigator: xuefeng luo Sichuan University

Responsible Party: luo xuefeng, Attending doctor, West China Hospital
ClinicalTrials.gov Identifier: NCT03171805     History of Changes
Other Study ID Numbers: Propranolol in GV
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Varicose Veins
Esophageal and Gastric Varices
Liver Cirrhosis
Hypertension, Portal
Liver Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents