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

This study is currently recruiting participants.

Verified August 2009 by Korea University

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

Tracking Information

First Received Date ^ICMJE

August 25, 2009

Last Updated Date

August 25, 2009

Start Date ^ICMJE

September 2006

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Variceal Bleeding
Cirrhosis

Intervention ^ICMJE

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).
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)
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)

Study Arm (s)

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

Intervention: Procedure: Endoscopic band ligation
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)

Intervention: Drug: Propranolol
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)
Intervention: Procedure: endoscopic band ligation and propranolol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

288

Estimated Completion Date

May 2014

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00965900

Other Study ID Numbers ^ICMJE

RCTPEBL

Has Data Monitoring Committee

Responsible Party

Liver Cirrhosis Clinical Research Center, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University Anam Hospital

Study Sponsor ^ICMJE

Korea University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Soon Ho Um, Prof

Korea University

Information Provided By

Korea University

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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