Evidence map›Paper›PMID 30053891›Full record

ArticleTrials2018

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.

Lucia Macken, Louise Mason, Catherine Evans, Heather Gage, Jake Jordan, Mark Austin, Nick Parnell, Max Cooper, Shani Steer, Justine Boles and 6 more

Erratum issuedOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Palliative long-term abdominal drainsWorld journal of hepatology · 2024
    Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 1 country.

Lucia MackenDepartment of Clinical and Experimental Medicine, Brighton and Sussex Medical School, Main Teaching Building, North South Road, University of Sussex, Falmer, Brighton, East Sussex, BN1 9PX, UK.
Louise MasonDepartment of Palliative Medicine, Brighton and Sussex University Hospitals Trust, Royal Sussex County Hospital, Eastern Rd, Brighton, East Sussex, BN2 5BE, UK.
Catherine EvansKing's College, Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, Bessemer Road, London, SE5 9PJ, UK.
Heather GageSurrey Health Economics Centre, School of Economics, Faculty of Arts and Social Sciences, University of Surrey, Guildford, Surrey, GU2 7XH, UK.
Jake JordanSurrey Health Economics Centre, School of Economics, Faculty of Arts and Social Sciences, University of Surrey, Guildford, Surrey, GU2 7XH, UK.
Mark AustinDepartment of Gastroenterology and Hepatology, Brighton and Sussex University Hospitals Trust, Royal Sussex County Hospital, Eastern Rd, Brighton, East Sussex, BN2 5BE, UK.
Nick ParnellDepartment of Gastroenterology and Hepatology, Brighton and Sussex University Hospitals Trust, Royal Sussex County Hospital, Eastern Rd, Brighton, East Sussex, BN2 5BE, UK.
Max CooperDepartment of Clinical and Experimental Medicine, Brighton and Sussex Medical School, Main Teaching Building, North South Road, University of Sussex, Falmer, Brighton, East Sussex, BN1 9PX, UK.
Shani SteerBrighton & Sussex Clinical Trials Unit, Room 204 Bevendean House, University of Brighton, Falmer, BN1 9PH, UK.
Justine BolesBrighton & Sussex Clinical Trials Unit, Room 204 Bevendean House, University of Brighton, Falmer, BN1 9PH, UK.
Stephen BremnerBrighton & Sussex Clinical Trials Unit, Room 204 Bevendean House, University of Brighton, Falmer, BN1 9PH, UK.
Debbie LambertBrighton & Sussex Clinical Trials Unit, Room 204 Bevendean House, University of Brighton, Falmer, BN1 9PH, UK.
David CrookBrighton & Sussex Clinical Trials Unit, Room 204 Bevendean House, University of Brighton, Falmer, BN1 9PH, UK.
Gemma EarlBrighton & Sussex Clinical Trials Unit, Room 204 Bevendean House, University of Brighton, Falmer, BN1 9PH, UK.
Jean TimeyinBrighton & Sussex Clinical Trials Unit, Room 204 Bevendean House, University of Brighton, Falmer, BN1 9PH, UK.
Sumita VermaDepartment of Clinical and Experimental Medicine, Brighton and Sussex Medical School, Main Teaching Building, North South Road, University of Sussex, Falmer, Brighton, East Sussex, BN1 9PX, UK. s.verma@bsms.ac.uk.
University of Brighton · GBRoyal Sussex County Hospital · GBBrighton and Sussex Medical School · GBUniversity of Surrey · GBCicely Saunders International · GBUniversity of Sussex · GB

Funding

Department of Health PB-PG-0214-33068Research for Patient Benefit Programme PB-PG-0214-33068
6 · The paper itself

Abstract

backgroundUK 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. METHODS/

designDue 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 (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. DISCUSSION: 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 registrationISRCTN, ISRCTN30697116 . Registered on 7 October 2015.

Indexed as

AdolescentAdultAgedAged, 80 and overAscitesDrainageEnd Stage Liver DiseaseEnglandFeasibility StudiesHumansLiver CirrhosisMiddle AgedMulticenter Studies as TopicPalliative CareQuality of LifeRandomized Controlled Trials as TopicAscitic fluidEnd-stage liver diseaseHealthcare economicsHealthrelated quality of lifePalliative careParacentesisPermanent indwelling peritoneal catheterQuality-adjusted life years

Identifiers

PMID30053891
PMCPMC6062920
OpenAlexW2816083797

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.