PROPRANOLOL PLUS LIGATION REDUCES RECURRENCE OF ESOPHAGEAL VARICES?
Condition: CIRRHOSIS; ESOPHAGEAL VARICES
MeSH terms: Esophageal and Gastric Varices; Varicose Veins; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective randomized controlled trial will compare endoscopic band ligation (EBL) with
      propranolol and EBL alone in primary prophylaxis of variceal bleeding among cirrhotic
      patients with high-risk varices.
    

Detailed description: 
      BACKGROUND AND AIMS

      Bleeding from esophagogastric varices (EV) is a major complication of portal hypertension.
      Beta-blockers are a well-established cornerstone of portal hypertension treatment. Band
      ligation is the best endoscopic treatment to prevent EV bleeding. The exact benefit of
      beta-blocker association to band ligation remains to be defined, especially for primary
      prophylaxis. This prospective randomized controlled trial will compare EBL with propranolol
      and EBL alone in primary prophylaxis of variceal bleeding among cirrhotic patients with
      high-risk varices. PATIENTS AND METHODS: The patients with high-risk varices will be randomly
      allocated to EBL plus propranolol (Group I) or EBL alone (Group II). EBL will be performed at
      3-week interval till obliteration of varices. In Group I, incremental dosage of propranolol
      (sufficient to reduce heart rate to 55 beats/min or 25% reduction from baseline) will be
      administered and will be continued after obliteration of varices until the end of the study.
      The follow-up of patients will be 2 years. The primary outcome of this study will be EV
      recurrence during two years of follow-up. The secondary outcomes will be EV eradication,
      bleeding before eradication, mortality and complications during the same follow-up.
    

Intervention name(s): ENDOSCOPIC BAND LIGATION; PROPRANOLOL; a multiband ligation device
Intervention type(s): Procedure; Drug; Device
Intervention description(s): The procedures will be performed using standard technique with a multiband ligation device. Elastic bands will be placed according to physician decision, starting at esophagogastric junction. All varices will be treated during the same session. Endoscopic band ligation sessions will be repeated at intervals of 3 to 4 weeks until all varices will be obliterated.; The initial propranolol dose will be orally BID 40 mg, irrespective of patient's weight. The objective of the administration of propranolol will be induce beta-adrenergic blockade evaluated by reduction in heart rate to 55 bpm or a 25% drop in baseline heart rate. A baseline electrocardiogram will be obtained from all patients. The doses will be adjusted during weekly visits until beta-adrenergic blockade. After the adequate dose will be reached, the visits will be scheduled monthly during the first 3 months (until EV eradication) and then at a 3-month interval until the end of follow-up.
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: CIRRHOTIC; VARICEAL BLEEDING; PRIMARY PROPHYLAXIS