A Phase 4 interventional study of endoscopic band ligation and EBL+Propranolol in Cirrhosis and Variceal Bleeding, sponsored by Korea University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-08-23.
Sponsored by Korea University · Phase 4, Interventional, and Prevention
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. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients without previous history of endoscopic variceal treatment.
3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.
This study's planned enrollment of 180 is above the median of 50 across 2,130 interventional studies indexed under Fibrosis.
Browse Fibrosis studies →Korea University is the lead sponsor of 64 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Perform endoscopic band ligation (EBL) until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval
Procedure: endoscopic band ligation
Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min
Procedure: EBL+Propranolol
* Perform EBL within 7 days after randomization * Apply 1-2 band/column/session to varices in the distal 5-7cm of the esophagus till they are eradicated (Disappearance or too small to apply band) with interval of 4weeks (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).
* Start with 20 mg b.i.d * Adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤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)
Rebleeding from esophageal varices
Rebleeding from esophageal varices
Time frame: 2 years
Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events
Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events
Time frame: 2 years
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Korea University