Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Korea University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT00965900
First received: August 25, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

Current guidelines recommend prophylactic treatment with propranolol or endoscopic band ligation (EBL) to prevent variceal bleeding in patients with medium or large varices. However, it is unclear which treatment is more useful in regard to prevention of variceal bleeding as well as safety. In addition, the efficacy and safety of the combination of EBL and propranolol is not still defined. This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.


Condition Intervention Phase
Variceal Bleeding
Cirrhosis
Procedure: Endoscopic band ligation
Drug: Propranolol
Procedure: endoscopic band ligation and propranolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • First esophageal variceal bleeding [ Time Frame: 3 years after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events [ Time Frame: 3 years after enrollment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 288
Study Start Date: September 2006
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endoscopic band ligation
Endoscopic band ligation until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment
Procedure: Endoscopic band ligation
  • Perform EBL within 7 days after randomization
  • Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (at 4,8,12 weeks after initial treatment)
  • Acid suppression using proton pump inhibitor until eradicated.
  • After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months).
Active Comparator: Propranolol
start with 20 mg b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
Drug: Propranolol
  • start with 20 mg of propranolol b.i.d
  • Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 55/min
  • After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
Active Comparator: EBL+Propranolol
  • EBL until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment
  • start with 20 mg of propranolol b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
Procedure: endoscopic band ligation and propranolol
  1. EBL

    • Perform EBL within 7 days after randomization
    • Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (at 4,8,12 weeks after initial treatment)
    • Acid suppression using proton pump inhibitor until eradicated.
    • After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months).
  2. Propranolol

    • start with 20 mg b.i.d
    • Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 55/min
    • After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver cirrhosis
  • Age between 18 and 70 years
  • Esophageal varices with high bleeding risk: more than F2 and red color sign
  • No previous history of upper gastrointestinal bleeding
  • No previous history of endoscopic, radiologic, or surgical therapy for varices or ascites
  • Do not take beta-blocker, ACE inhibitor, or nitrate
  • Child-Pugh score <12

Exclusion Criteria:

  • Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min
  • Portal vein thrombosis
  • Uncontrolled ascites or hepatic encephalopathy
  • Severe coagulation disorder: prothrombin time <40% (or INR >1.7) or platelet count <30,000/mm3
  • Medium or large sized gastric or duodenal varices
  • Coexisting malignancy
  • Severe cardiovascular disorder, renal failure, peritonitis, sepsis
  • Severe erosive esophagitis, severe esophageal stricture, active gastric or duodenal ulcer
  • Contraindication to beta-blocker
  • Pregnancy
  • Refusal to give consent to participate in the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965900

Contacts
Contact: Soon Ho Um, Prof 82-2-920-5019 umsh@korea.ac.kr
Contact: Yeon Seok Seo, MD 82-2-920-6608 drseo@korea.ac.kr

Locations
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Korea University
Investigators
Principal Investigator: Soon Ho Um, Prof Korea University
  More Information

No publications provided

Responsible Party: Liver Cirrhosis Clinical Research Center, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT00965900     History of Changes
Other Study ID Numbers: RCTPEBL
Study First Received: August 25, 2009
Last Updated: August 25, 2009
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea University:
Cirrhosis
Esophagus Disorders
Varicose Veins

Additional relevant MeSH terms:
Liver Cirrhosis
Hemorrhage
Liver Diseases
Digestive System Diseases
Pathologic Processes
Propranolol
Proton Pump Inhibitors
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014