Topic: Gastroenterology
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Presence of untreatable (refractory) ascites, defined as: 2.1. Ascites that are unresponsive to fluid and sodium restriction and high dose diuretic treatment (spironolactone 400 mg and or furosemide 160 mg) and/or intolerance of diuretics 2.2. Recurs rapidly after LVP (need for one or more LVP per month). 3. Child Pugh Score of greater than 9. unless specifically decided by the medical team that they are to receive only palliative treatment. If less than 9, the participant is considered palliative by medical team. 4. 4. Registered with a GP in Brighton and Hove or West Sussex with community Integrated Primary Care Team provision from Sussex Community NHS Trust 5. Ability to speak read and understand English 6. Capacity to give informed consent as defined using the Capacity to Consent Checklist 7. Signed, informed consent prior to any study specific procedures
Exclusion criteria
Exclusion criteria: 1. Either loculated or chylous ascites 2. Presence of > grade 1 hepatic encephalopathy (specified by West Haven Criteria – appendix 13) 3. 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 reconsidered 4. A candidate for liver transplantation 5. Psychosocial issues which in the opinion of the medical team will preclude study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability of LTAD to patients/carers and staff to be measured at end of study (3 months) or at the time of patient death, which ever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures. | — |
Countries
United Kingdom