Palliative long-term abdominal drains versus repeated drainage in individuals with untreatable ascites due to advanced cirrhosis: a feasibility randomised controlled trial

Brighton and Sussex University Hospitals NHS Trust0 个研究点目标入组 59 人开始时间: 2015年10月7日最近更新: 2021年3月15日

适应症

试验速览

•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

•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

发起方

Brighton and Sussex University Hospitals NHS Trust