Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding - Full Text View

Sponsor:	Korea University
Information provided by:	Korea University
ClinicalTrials.gov Identifier:	NCT00965900

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cirrhosis Endoscopy Esophagus Disorders Varicose Veins

Drug Information available for: Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

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
Endoscopic band ligation: Active Comparator 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).
Propranolol: Active Comparator 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)
EBL+Propranolol: Active Comparator 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 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). 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

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 College of Medicine

More Information

No publications provided

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

Keywords provided by Korea University:

Cirrhosis
Esophagus Disorders
Varicose Veins

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Fibrosis
Physiological Effects of Drugs
Liver Cirrhosis
Cardiovascular Agents
Hemorrhage

Antihypertensive Agents
Pharmacologic Actions
Pathologic Processes
Digestive System Diseases
Propranolol
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on February 08, 2010