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

Macken, Lucia, Mason, Louise, Evans, Catherine, Gage, Heather, Jordan, Jake, Austin, Mark, Parnell, Nick, Cooper, Max, Steer, Shani, Boles, Justine , Bremner, Stephen, Lambert, Debbie, Crook, David, Earl, Gemma, Timeyin, Jean and Verma, Sumita (2018) Palliative long-term abdominal drains versus repeated drainage in individuals with untreatable ascites due to advanced cirrhosis: study protocol for a feasibility randomised controlled trial Trials, 19 (401).

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UK deaths due to chronic liver diseases such as cirrhosis have quadrupled over the last 40 years, making this condition now the third most common cause of premature death. Most patients with advanced cirrhosis (end-stage liver disease [ESLD]) develop ascites. This is often managed with diuretics, but if refractory, then the fluid is drained from the peritoneal cavity every 10–14 days by large volume paracentesis (LVP), a procedure requiring hospital admissions. As the life expectancy of patients with ESLD and refractory ascites (if ineligible for liver transplantation) is on average ≤ 6 months, frequent hospital visits are inappropriate from a palliative perspective. One alternative is long-term abdominal drains (LTADs), used successfully in patients whose ascites is due to malignancy. Although inserted in hospital, these drains allow ascites management outside of a hospital setting. LTADs have not been formally evaluated in patients with refractory ascites due to ESLD.


Due to uncertai/nty about appropriate outcome measures and whether patients with ESLD would wish or be able to participate in a study, a feasibility randomised controlled trial (RCT) was designed. Patients were consulted on trial design. We plan to recruit 48 patients with refractory ascites and randomise them (1:1) to either (1) LTAD or (2) current standard of care (LVP) for 12 weeks. Outcomes of interest include acceptability of the LTAD to patients, carers and healthcare professionals as well as recruitment and retention rates. The Integrated Palliative care Outcome Scale, the Short Form Liver Disease Quality of Life questionnaire, the EuroQol 5 dimensions instrument and carer-reported (Zarit Burden Interview) outcomes will also be assessed. Preliminary data on cost-effectiveness will be collected, and patients and healthcare professionals will be interviewed about their experience of the trial with a view to identifying barriers to recruitment.


LTADs could potentially improve end-of-life care in patients with refractory ascites due to ESLD by improving symptom control, reducing hospital visits and enabling some self-management. Our trial is designed to see if such patients can be recruited, as well as to inform the design of a subsequent definitive trial.

Trial registration

ISRCTN, ISRCTN30697116. Registered on 7 October 2015.

Item Type: Article
Divisions : Faculty of Health and Medical Sciences > School of Biosciences and Medicine
Authors :
Macken, Lucia
Mason, Louise
Evans, Catherine
Austin, Mark
Parnell, Nick
Cooper, Max
Steer, Shani
Boles, Justine
Bremner, Stephen
Lambert, Debbie
Crook, David
Earl, Gemma
Timeyin, Jean
Verma, Sumita
Date : 27 July 2018
DOI : 10.1186/s13063-018-2779-0
Copyright Disclaimer : © The Author(s). 2018. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
Uncontrolled Keywords : Ascitic fluid; End-stage liver disease; Paracentesis; Permanent indwelling peritoneal catheter; Palliative care; Healthrelated quality of life; Quality-adjusted life years; Healthcare economics
Depositing User : Clive Harris
Date Deposited : 05 Dec 2018 14:53
Last Modified : 05 Dec 2018 14:53

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