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

NCT ID: NCT00965900

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2021-05-31

Brief Summary

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

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.

Conditions

Variceal Bleeding; Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Endoscopic band ligation

Intervention Type: PROCEDURE

• 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, 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)

Group Type: ACTIVE_COMPARATOR

Propranolol

Intervention Type: DRUG

• 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

• 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)

Group Type: ACTIVE_COMPARATOR

EBL+Propranolol

Intervention Type: PROCEDURE

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)

Interventions

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).

Intervention Type: PROCEDURE

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)

Intervention Type: DRUG

EBL+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)

Intervention Type: PROCEDURE

Other Intervention Names

EBL; Beta blocker; EBL+Beta blocker

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University

OTHER

Sponsor Role: lead

Responsible Party

Soon Ho Um

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soon Ho Um, Prof

Role: PRINCIPAL_INVESTIGATOR

Korea University

Locations

Korea University Anam Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Soon Ho Um, Prof

Role: CONTACT

umsh@korea.ac.kr

82-2-920-5019

Yeon Seok Seo, MD

Role: CONTACT

drseo@korea.ac.kr

82-2-920-6608

Other Identifiers

RCTPEBL

Identifier Type: -

Identifier Source: org_study_id