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Preventing Recurrent Bleeding After Eradication of Esophageal Varices

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ClinicalTrials.gov Identifier: NCT02740166
Recruitment Status : Unknown
Verified April 2016 by Wen-Chi Chen, Kaohsiung Veterans General Hospital..
Recruitment status was:  Recruiting
First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Wen-Chi Chen, Kaohsiung Veterans General Hospital.

Brief Summary:
Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.

Condition or disease Intervention/treatment Phase
Esophageal Varices Drug: propranolol Phase 4

Detailed Description:
Cirrhotic patients with acute or recent esophageal variceal bleeding undergo banding ligation at 1-month interval until eradication of esophageal varices. Patients start propranolol (start with 30 mg daily) at 6th day after control of acute bleeding till eradication of esophageal varices, aiming at decreasing pulse rate to 25% or to 55 bpm while systolic pressure is above 85 mmHg. Patients randomized to propranolol group continue propranolol after eradication of esophageal varices. Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. Patients are followed to evaluate the incidence of rebleeding, adverse effects and survival.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Banding Ligation Plus Propranolol Versus Banding Ligation to Prevent Rebleeding of Esophageal Varices
Study Start Date : June 2013
Estimated Primary Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
No Intervention: Banding ligation group
Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices.
Experimental: Propranolol group
Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.
Drug: propranolol
Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.




Primary Outcome Measures :
  1. recurrent esophageal variceal bleeding [ Time Frame: 6 years ]
    recurrent esophageal variceal bleeding after eradication of esophageal varices

  2. mortality or liver transplantation [ Time Frame: 6 years ]
    mortality or liver transplantation after eradication of esophageal varices


Secondary Outcome Measures :
  1. adverse effects [ Time Frame: 6 years ]
    adverse effects associated with non-selective beta-blockers and banding ligation



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 20 to 80 years
  • Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy
  • Stable hemodynamic condition for at least 3 days after banding ligation

Exclusion Criteria:

  • Hepatocellular carcinoma or other malignancy
  • Stroke or active sepsis
  • Chronic kidney disease under renal replacement therapy
  • Contraindications to non-selective beta-blockers
  • A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery
  • Serum total bilirubin >10 mg/dL
  • Grade III/IV hepatic encephalopathy
  • Refractory ascites
  • Hepato-renal syndrome
  • Pregnancy
  • Severe heart failure (NYHA Fc III/IV)
  • Bronchial asthma or chronic obstructive pulmonary disease
  • Second or third degree atrioventricular block
  • Sick sinus syndrome
  • Pacemaker use
  • Severe hypotension
  • Refusal to participate

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): NCT02740166


Contacts
Contact: Wen-Chi Chen, MD 886-7-3422121 ext 2139 wcchen@vghks.gov.tw

Locations
Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 813
Contact: Wen-Chi Chen, MD    +886-7-3422121 ext 2139    wcchen@vghks.gov.tw   
Principal Investigator: Wen-Chi Chen, MD         
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Principal Investigator: Wen-Chi Chen, MD Kaohsiung Veterans General Hospital.

Publications:
Responsible Party: Wen-Chi Chen, Division of Gastroenterology and Hepatology, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT02740166     History of Changes
Other Study ID Numbers: VGHKS13-CT6-06
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Wen-Chi Chen, Kaohsiung Veterans General Hospital.:
Esophageal Varices; propranolol; banding ligation

Additional relevant MeSH terms:
Varicose Veins
Esophageal and Gastric Varices
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver 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