Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding

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:
NCT00966121
First received: August 25, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal rebleeding. Recently several studies compared the efficacy of EBL alone and with a combination of propranolol and EBL. However, the results of recent studies showed discrepancy. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients without previous history of endoscopic variceal treatment.


Condition Intervention Phase
Cirrhosis
Variceal Bleeding
Procedure: endoscopic band ligation
Procedure: EBL+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: RCT Comparing the Efficacies of Endoscopic Variceal Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • Rebleeding from esophageal varices [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: August 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endoscopic band ligation
Perform endoscopic band ligation (EBL) until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval
Procedure: endoscopic band ligation
  • Perform EBL within 7 days after randomization
  • Apply 1-2 band/column/session to varices in the distal 5-7cm of the esophagus till they are eradicated (Disappearance or too small to apply band) with interval of 4weeks (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: EBL+Propranolol
Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min
Procedure: EBL+Propranolol
  • Start with 20 mg b.i.d
  • Adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤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
  • Successful control of esophageal variceal bleeding within 6 weeks before enrollment

Exclusion Criteria:

  • Gastric variceal bleeding
  • Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min
  • Portal vein thrombosis
  • Prominent hepatic encephalopathy
  • Coexisting untreated malignancy
  • Severe cerebrovascular or cardiovascular disease, renal failure
  • Previous history of endoscopic, radiologic, or surgical treatment for varices or ascites
  • 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: NCT00966121

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
  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: NCT00966121     History of Changes
Other Study ID Numbers: EBLPPL-1
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:
Propranolol
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

ClinicalTrials.gov processed this record on October 16, 2014