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[Study Protocol] 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

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posted on 2023-06-12, 07:23 authored by Lucia MackenLucia Macken, Louise Mason, Catherine Evans, Heather Gage, Jake Jordan, Mark Austin, Nick Parnell, Maxwell CooperMaxwell Cooper, Shani Steer, Justine Boles, Stephen BremnerStephen Bremner, Debbie LambertDebbie Lambert, David Crook, Gemma Earl, Jean Timeyin, Sumita VermaSumita Verma
Background: 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 (LTAD), used successfully in patients whose ascites is due to malignancy. Although inserted in hospital, these drains allow ascites management outside of a hospital setting. LTAD have not been formally evaluated in patients with refractory ascites due to ESLD. Methods: Due to uncertainty 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 a) LTAD or b) current standard of care (LVP) for 12 weeks. Outcomes of interest include acceptability of LTAD to patients, carers and healthcare professionals as well as recruitment and retention rates. Palliative care Outcome Scale (IPOS), the Short Form Liver Disease Quality of Life (SF-LDQOL), the EuroQol (EQ-5D) and carer (Zarit Burden Interview [ZBI-12]) reported 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. Discussion: LTAD 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 informing the design of a subsequent definitive trial. Trial registration: ISRCTN30697116, date assigned: 07/10/2015

Funding

Pallative long-term tunnelled abdominal catheter verus large volume paracentesis in supporting individuals with refractory ascites due to end stage cirrhosis: a randomised controlled trial; G1835; NATIONAL INSTITUTE FOR HEALTH RESEARCH; PB-PG-0214-33068

History

Publication status

  • Published

File Version

  • Published version

Journal

Trials

ISSN

1745-6215

Publisher

BioMed Central

Issue

401

Volume

19

Page range

1-15

Department affiliated with

  • BSMS Publications

Research groups affiliated with

  • Centre for Global Health Policy Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2018-07-02

First Open Access (FOA) Date

2018-07-02

First Compliant Deposit (FCD) Date

2018-06-29

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