Colorectal Surgery in Cirrhosis study (CSi Cirrhosis)
Research type
Research Study
Full title
Colorectal Surgery in Cirrhosis study (CSi Cirrhosis)
IRAS ID
296478
Contact name
John Hammond
Contact email
Sponsor organisation
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Cirrhosis is a condition where the liver becomes scarred and loses function. It is an important and often under recognised condition, affecting over 300,000 patients across the North East and Cumbria. In patients who require surgery on their stomach or bowel, cirrhosis can be associated with high rates of death and complications and may become a barrier to patients accessing surgery. Currently we lack a reliable method of identifying which patients with cirrhosis are most at risk of death and other complications. This study sets out to develop a new method of establishing the risk of surgery in patients with cirrhosis.
An important complication cirrhosis is the development of high pressure in the veins that supply blood to the liver. Measuring the pressure in the liver blood vessels can predict the risk of complications after surgery. This study sets out to develop a series of tests that can be used to measure the pressure and calculate that risk. We will undertake this study in 30 patients with cirrhosis who need to have surgery to treat their bowel or stomach cancer. We will measure the pressure in the blood vessels supplying the liver and investigate what happens if they have surgery or if surgery is not safe. We will then use this data to design a larger, UK–based study to establish the risk of surgery in patients with cirrhosis and whether the degree of pressure corresponds with that risk. This study will enable surgeons to help patients with cirrhosis decide what is the best treatment if they develop cancer and potentially explore the role of strategies to modify pressure and improve their outcomes.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0289
Date of REC Opinion
20 Dec 2021
REC opinion
Unfavourable Opinion