EUCTR2018-002509-78-GB
Active, not recruiting
Phase 1
Beta-blockers Or Placebo for Primary Prophylaxis of oesophageal varices (BOPPP Trial). A blinded, UK multi-centre, clinical effectiveness and cost-effectiveness randomised controlled trial. - Beta-blockers or placebo for primary prophylaxis (BOPPP) of oesophageal varices trial.
Kings College Hospital NHS Foundation Trust0 sites1,200 target enrollmentJanuary 24, 2019
Conditionsiver cirrhosis with small oesophageal varicesMedDRA version: 20.0Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 100000004871MedDRA version: 21.1Level: LLTClassification code 10055489Term: Esophageal varices in cirrhosis of liverSystem Organ Class: 100000004856Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- iver cirrhosis with small oesophageal varices
- Sponsor
- Kings College Hospital NHS Foundation Trust
- Enrollment
- 1200
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •o Age 18 years and over
- •o Cirrhosis and portal hypertension, defined by any 2 of the following:
- •1\) Characteristic clinical examination findings; one or more of:
- •Characteristic liver function tests
- •Haematological panel
- •Coagulation profile abnormalities
- •2\)Characteristic radiological findings; one or more of
- •Heterogeneous liver with irregular contour
- •splenomegaly
- •recanalized umbilical vein
Exclusion Criteria
- •o Non\-cirrhotic portal hypertension
- •o Medium/large oesophageal varices (current or history \[decreasing in size without curative therapy), defined as \>5 mm in diameter
- •o Gastric (IGV and GOV2\), duodenal, rectal varices with or without evidence of recent bleeding. For gastric varices, this includes:
- •? IGV\-1 and IGV\-2 (isolated gastric varices)
- •? GOV2 (gastric varices continuing into the cardia)
- •? Note GOV1 (gastric varices continuing into the lesser curve) are not an exclusion if present with small oesophageal varices
- •o Previous variceal haemorrhage
- •o Previous band ligation or glue injection of oesophageal and/or gastric varices
- •o Red signs accompanying varices at endoscopy
- •o Known intolerance to beta blockers
Outcomes
Primary Outcomes
Not specified
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