Cirrhoses, Liver Clinical Trial
Official title:
Beta-blockers or Placebo for Primary Prophylaxis of Oesophageal Varices (BOPPP Trial). A Blinded, Multi-centre, Clinical Effectiveness and Cost-effectiveness Randomised Controlled Trial
To determine if carvedilol reduces the rate of variceal haemorrhage in patients with cirrhosis and small oesophageal varices
Cirrhosis or liver scarring is an important problem in healthcare in the United Kingdom.
60,000 patients are living with this disease and about 11,000 people every year will die
because of it. There are several ways in which patients with this severe form of liver
disease become unwell or die and bleeding from the oesophagus or stomach is one. Cirrhosis
causes pressure changes inside the abdomen and swelling of veins in the oesophagus (called
"varices") which can bleed catastrophically.
The investigators know that when varices are large, treatment can be initiated with
medication called beta-blockers to reduce the pressure in the varices. If the varices are
small, the medical community is not sure if treatment with beta-blockers will work. This
study aims to address this uncertainty.
Patients who are recruited to the study with small varices will be randomised to either
beta-blockers or a placebo. Research sites will observe patients closely for 3 years for
bleeding from their varices or other complications of cirrhosis or side effects of taking
medication. This is the amount of time needed to observe for bleeding when the varices are
small. Research sites will review the patients every 6 months including assessing the varices
by a camera test called an endoscopy at the beginning and each year until the study is
finished.
During the study, patients will be involved with the conduct and management of the research.
Patient will also be notified on the trial results at the end of the study. The barriers and
facilitators in adjusting the dose of the tablets to optimise treatment effects primary care
will be along with patients' views on taking part in the trial, and whether the side effects
justify the potential benefits of reducing the risk of bleeding. The investigators estimate
this risk could be reduced from 20% of patients having significant bleeding to 10% over 3
years.
The investigators will measure the impact of beta-blockers on the overall costs to the
National Health Service (NHS) of caring for people with cirrhosis during the trial, and will
also assess the impact of treatment on both mortality and quality of life using a combined
measure, the Quality Adjusted Life-Year (QALY). The investigators will use a mathematical
prediction model to estimate the impact of treatment on costs, mortality and quality of life
over a patient's lifetime and will assess whether any increased costs are justified by better
outcomes for patients and represent good value for money for the NHS budget.
Finally, the results of the study will be published in the medical literature and discuss the
findings at medical conferences, patient groups and with charities involved in helping
patients with cirrhosis such as the British Liver Trust.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01335516 -
Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices
|
N/A | |
| Completed |
NCT02852161 -
The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study
|
N/A |