Preventing Recurrent Bleeding After Eradication of Esophageal Varices
Banding Ligation Plus Propranolol Versus Banding Ligation to Prevent Rebleeding of Esophageal Varices
1 other identifier
interventional
212
1 country
1
Brief Summary
Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 12, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedApril 15, 2016
April 1, 2016
4.6 years
April 12, 2016
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
recurrent esophageal variceal bleeding
recurrent esophageal variceal bleeding after eradication of esophageal varices
6 years
mortality or liver transplantation
mortality or liver transplantation after eradication of esophageal varices
6 years
Secondary Outcomes (1)
adverse effects
6 years
Study Arms (2)
Banding ligation group
NO INTERVENTIONPatients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices.
Propranolol group
EXPERIMENTALPatients randomized to propranolol group continue propranolol after eradication of esophageal varices.
Interventions
Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.
Eligibility Criteria
You may qualify if:
- Age of 20 to 80 years
- Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy
- Stable hemodynamic condition for at least 3 days after banding ligation
You may not qualify if:
- Hepatocellular carcinoma or other malignancy
- Stroke or active sepsis
- Chronic kidney disease under renal replacement therapy
- Contraindications to non-selective beta-blockers
- A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery
- Serum total bilirubin \>10 mg/dL
- Grade III/IV hepatic encephalopathy
- Refractory ascites
- Hepato-renal syndrome
- Pregnancy
- Severe heart failure (NYHA Fc III/IV)
- Bronchial asthma or chronic obstructive pulmonary disease
- Second or third degree atrioventricular block
- Sick sinus syndrome
- Pacemaker use
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, 813, Taiwan
Related Publications (5)
Gonzalez R, Zamora J, Gomez-Camarero J, Molinero LM, Banares R, Albillos A. Meta-analysis: Combination endoscopic and drug therapy to prevent variceal rebleeding in cirrhosis. Ann Intern Med. 2008 Jul 15;149(2):109-22. doi: 10.7326/0003-4819-149-2-200807150-00007.
PMID: 18626050BACKGROUNDLo GH, Lai KH, Cheng JS, Chen MH, Huang HC, Hsu PI, Lin CK. Endoscopic variceal ligation plus nadolol and sucralfate compared with ligation alone for the prevention of variceal rebleeding: a prospective, randomized trial. Hepatology. 2000 Sep;32(3):461-5. doi: 10.1053/jhep.2000.16236.
PMID: 10960435BACKGROUNDde la Pena J, Brullet E, Sanchez-Hernandez E, Rivero M, Vergara M, Martin-Lorente JL, Garcia Suarez C. Variceal ligation plus nadolol compared with ligation for prophylaxis of variceal rebleeding: a multicenter trial. Hepatology. 2005 Mar;41(3):572-8. doi: 10.1002/hep.20584.
PMID: 15726659BACKGROUNDKumar A, Jha SK, Sharma P, Dubey S, Tyagi P, Sharma BC, Sarin SK. Addition of propranolol and isosorbide mononitrate to endoscopic variceal ligation does not reduce variceal rebleeding incidence. Gastroenterology. 2009 Sep;137(3):892-901, 901.e1. doi: 10.1053/j.gastro.2009.05.049. Epub 2009 May 27.
PMID: 19481079BACKGROUNDChen WC, Yang TC, Lee PC, Wang YP, Hou MC, Lee FY. A Randomized Controlled Trial of Propranolol Use During Ligation Program for Secondary Prophylaxis of Esophageal Variceal Bleeding. Am J Gastroenterol. 2024 Feb 1;119(2):278-286. doi: 10.14309/ajg.0000000000002457. Epub 2023 Sep 11.
PMID: 37543755DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wen-Chi Chen, MD
Kaohsiung Veterans General Hospital.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division of Gastroenterology and Hepatology
Study Record Dates
First Submitted
April 12, 2016
First Posted
April 15, 2016
Study Start
June 1, 2013
Primary Completion
January 1, 2018
Last Updated
April 15, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will share