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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Alison
Porges
None provided
a.porges@bsms.ac.uk
Prof
Sumita
Verma
+44 (0)1273 877890
s.verma@bsms.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Complications of cirrhosis
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The liver can be damaged (scarred) by excessive alcohol and viral infections. If liver damage continues, this scarring leads to permanent damage (cirrhosis). As cirrhosis progresses, it causes a painful buildup of fluid (ascites) in the belly (abdomen). Initially, drugs can treat ascites, but these may stop working, leading to untreatable ascites. A liver transplant is then the best option. Most people, however, do not receive a transplant due to concerns about their alcohol use or lack of donors.
People with cirrhosis and untreatable ascites who do not receive a liver transplant live on average for about six months. Medical care then focuses on controlling symptoms and having the best possible quality of life. This is known as palliative care. Current standard palliative care for untreatable ascites involves coming into the hospital for 1-2 days, putting a thin tube into the abdomen for a few hours and draining 5-15 L of fluid. This reduces the pain from ascites. However, as the ascites build up quickly, hospital visits are needed every 10-14 days. Our patients describe repeated hospital drainage as ”devastating” and “unbearably painful”.
For people with untreatable ascites due to cancer (rather than cirrhosis), palliative care involves placing another tube, a long-term abdominal drain (LTAD), into their abdomen. This tube is fitted in the hospital but stays in place for months. Nurses/caregivers then drain smaller amounts of fluid (1-2 L) up to three times a week in the community. LTADs avoid frequent hospital visits and can improve their quality of life.
LTADs are not routinely offered to people with cirrhosis as they can have complicated social issues like addiction, making community care difficult. Secondly, people with cirrhosis are at increased risk of ascitic fluid infection. The concern is that LTADs might further increase this risk. It remains uncertain, therefore, if LTADs could improve the quality of life for people with cirrhosis.
We ran a small study (2015-18) with 36 patients with cirrhosis and untreatable ascites. Half received LTADs and half continued with standard hospital drainage. LTAD insertion went well with no major complications. Almost all with LTAD were managed in the community with lower overall costs compared with hospital drainage. Participants were willing to fill in study questionnaires and take part in interviews. Patients and clinical staff told us that LTADs were acceptable to them.
We are now running a larger study to understand the risks/benefits of palliative LTADs in people with cirrhosis. Our aim is to see if palliative LTADs result in a better quality of life in patients with fluid in the abdomen due to liver scarring, compared with the current standard of care.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/40468365/ (added 09/06/2025)
You can take part if:
You may not be able to take part if:
Current exclusion criteria as of 04/12/2024:
1. Loculated and or chylous ascites2. Evidence of active infection that in the investigator’s opinion would preclude insertion of LTAD (for example, bacterial peritonitis) – such patients would need to receive appropriate treatment and could then be reconsidered3. A candidate for liver transplantation and or TIPS4. Psychosocial issues which in the opinion of the medical team will preclude study participation5. Pregnancy - all women of childbearing age must have a negative pregnancy test6. Lacks Capacity to give informed consent
_____
Previous exclusion criteria:1. Loculated and or chylous ascites2. Evidence of active infection that in the investigator’s opinion would preclude insertion of LTAD (for example, bacterial peritonitis) – such patients would need to receive appropriate treatment and could then be reconsidered3. A candidate for liver transplantation and or TIPS4. Psychosocial issues which in the opinion of the medical team will preclude study participation5. Pregnancy - all women of childbearing age must have a negative pregnancy test
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Sumita
Verma
+44 (0)1273 877890
s.verma@bsms.ac.uk
Ms
Alison
Porges
None provided
a.porges@bsms.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Sussex and funded by National Institute for Health and Care Research Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR133889.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 52988
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