Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00966082
Other study ID # EBLPPL-2
Secondary ID
Status Recruiting
Phase Phase 4
First received August 25, 2009
Last updated August 21, 2017
Start date August 2008
Est. completion date July 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
Health authority
Study type Interventional

Clinical Trial Summary

This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.


Description:

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. In addition, most of all recent studies included patients without previous endoscopic treatment for varices. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date July 2021
Est. primary completion date July 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

- 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

- No 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
endoscopic band ligation
Perform EBL until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval
endoscopic band ligation+Propranolol
Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR =55/min

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 Rebleeding from esophageal varices Rebleeding from esophageal varices 2 years
Secondary Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events 2 years
See also
  Status Clinical Trial Phase
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05014594 - Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT Phase 2
Not yet recruiting NCT03631147 - The Effect of Rifaximin on Portal Vein Thrombosis N/A
Completed NCT04939350 - Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
Completed NCT02528760 - To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis N/A
Recruiting NCT05484206 - Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Phase 1
Not yet recruiting NCT05538546 - Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
Not yet recruiting NCT04053231 - Hepatocarcinoma Recurrence on the Liver Study - Part2
Recruiting NCT02983968 - Use of the French Healthcare Insurance Database
Completed NCT02705534 - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 Phase 3
Completed NCT02596880 - Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics Phase 3
Completed NCT02247414 - Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection Phase 4
Withdrawn NCT01956864 - Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer Phase 1
Completed NCT02016196 - Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS Phase 3
Completed NCT01447537 - Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis N/A
Completed NCT02113631 - Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir N/A
Completed NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Active, not recruiting NCT01205074 - ¹³C-Methacetin Breath Test (MBT) Methodology Study Phase 2/Phase 3
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01231828 - Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. N/A