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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00965900
• Other study ID #: RCTPEBL
• Status: Recruiting
• Phase: Phase 4
• First received: August 25, 2009
• Last updated: August 22, 2017
• Start date: September 2006
• Est. completion date: May 2021

Study information

• Verified date: August 2017
• Source: Korea University
• Contact: Soon Ho Um, Prof
• Phone: 82-2-920-5019
• Email: umsh[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: May 2021
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hemorrhage
• Liver Cirrhosis
• Variceal Bleeding

Intervention

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:
• EBL+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)

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First esophageal variceal bleeding	First esophageal variceal bleeding after enrollment	3 years after enrollment
Secondary	Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events	Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events	3 years after enrollment