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

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ClinicalTrials.gov Identifier: NCT00965900
Recruitment Status : Recruiting
First Posted : August 26, 2009
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):

August 25, 2009
August 26, 2009
August 23, 2017
September 2006
May 2019   (Final data collection date for primary outcome measure)
First esophageal variceal bleeding [ Time Frame: 3 years after enrollment ]
First esophageal variceal bleeding after enrollment
First esophageal variceal bleeding [ Time Frame: 3 years after enrollment ]
Complete list of historical versions of study NCT00965900 on ClinicalTrials.gov Archive Site
Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events [ Time Frame: 3 years after enrollment ]
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 [ Time Frame: 3 years after enrollment ]
Not Provided
Not Provided
 
Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Variceal Bleeding
  • Cirrhosis
  • 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).
    Other Name: EBL
  • 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)
    Other Name: Beta blocker
  • Procedure: 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)
    Other Name: EBL+Beta blocker
  • 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: EBL+Propranolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
288
May 2021
May 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
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
Korea, Republic of
 
 
NCT00965900
RCTPEBL
No
Not Provided
Not Provided
Soon Ho Um, Korea University
Korea University
Not Provided
Principal Investigator: Soon Ho Um, Prof Korea University
Korea University
August 2017

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