CALIBRE

• Research type

  Research Study

• Full title

  CArvediloL versus variceal Band ligation in primary pREvention of variceal bleeding in liver cirrhosis

• IRAS ID

  248487

• Contact name

  Dhiraj Tripathi

• Contact email

  Dhiraj.Tripathi@uhb.nhs.uk

• Eudract number

  2018-002488-24

• Duration of Study in the UK

  5 years, 6 months, 31 days

• Research summary

  Individuals with liver cirrhosis (scarring of the liver) can develop enlargement of veins in the gullet (food pipe) known as ‘oesophageal varices’. Patients with medium to large oesophageal varices have a 1 in 3 chance of these veins bleeding. In severe cases this could result in death. It is therefore important to lower the risk of this bleeding. At present all patients with medium to large oesophageal varices are offered one of two treatments to lower the risk of bleeding:

  Variceal banding
  A flexible tube (endoscope) with a miniature video camera and carrying a rubber ring is passed through the mouth to the gullet. An enlarged vein can be tied off with the rubber ring. Several (sometimes up to five) endoscopy sessions at approximately monthly intervals will be required to treat all of the varices. Subsequently, regular checks will be carried out at three, six then 12 months, then annually thereafter.
  
  Beta-blocker drugs
  Beta-blockers slow down the heart rate and lower blood pressure. These drugs are either carvedilol, propranolol. Carvedilol is used to treat high blood pressure and some forms of heart disease. Research studies have shown carvedilol to be also very effective and better than propranolol at lowering the pressure in varices in the gullet (the lower the pressure, the lower the risk of bleeding). Patients tolerating beta-blocker tablets will not require any more routine endoscopies to check on their varices.

  Some research studies suggest that banding may be more effective than beta-blockers in lowering the risk of variceal bleeding, but other studies suggest that this is not the case. However, all of these studies have been small and we still don’t know what treatment is best. CALIBRE aims to compare carvedilol with banding in people with cirrhosis who have medium to large varices that have never bled.

• REC name

  North East - York Research Ethics Committee

• REC reference

  18/NE/0296

• Date of REC Opinion

  19 Oct 2018

• REC opinion

  Further Information Favourable Opinion