Evidence map›Paper›PMID 40468365›Full record

ArticleTrials2025

Palliative long-term abdominal drains vs. large volume paracentesis for refractory ascites secondary to cirrhosis: protocol for a definitive randomised controlled trial (REDUCe2 study).

Yazan Haddadin, Vasso Anagnostopoulou, Stephen Bremner, Helena Harder, Rachel Starkings, Debbie Lambert, Alison Porges, Nicky Perry, Wendy Wood, Amy Arbon and 16 more

Erratum issuedAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. 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 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Yazan HaddadinDepartment of Clinical and Experimental Medicine, Brighton & Sussex Medical School, University of Brighton and University of Sussex, Brighton, BN1 9PX, UK.
Vasso AnagnostopoulouDepartment of Primary Care and Public Health, Brighton & Sussex Medical School, Brighton, BN1 9PX, UK.
Stephen BremnerDepartment of Primary Care and Public Health, Brighton & Sussex Medical School, Brighton, BN1 9PX, UK.
Helena HarderSussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton & Sussex Medical School, Brighton, BN1 9PX, UK.
Rachel StarkingsSussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton & Sussex Medical School, Brighton, BN1 9PX, UK.
Debbie LambertBrighton and Sussex Clinical Trials Unit, Department of Clinical and Experimental Medicine, Brighton & Sussex Medical School, Brighton, BN1 9PX, UK.
Alison PorgesBrighton and Sussex Clinical Trials Unit, Department of Clinical and Experimental Medicine, Brighton & Sussex Medical School, Brighton, BN1 9PX, UK.
Nicky PerryBrighton and Sussex Clinical Trials Unit, Department of Clinical and Experimental Medicine, Brighton & Sussex Medical School, Brighton, BN1 9PX, UK.
Wendy WoodBrighton and Sussex Clinical Trials Unit, Department of Clinical and Experimental Medicine, Brighton & Sussex Medical School, Brighton, BN1 9PX, UK.
Amy ArbonBrighton and Sussex Clinical Trials Unit, Department of Clinical and Experimental Medicine, Brighton & Sussex Medical School, Brighton, BN1 9PX, UK.
Heather GageSurrey Health Economics Centre, University of Surrey, Guildford, GU2 7XH, UK.
Matthew GloverSurrey Health Economics Centre, University of Surrey, Guildford, GU2 7XH, UK.
Lucia MackenDepartment of Clinical and Experimental Medicine, Brighton & Sussex Medical School, University of Brighton and University of Sussex, Brighton, BN1 9PX, UK.
Malcolm JohnstonDepartment of Radiology, University Hospitals Sussex NHS Foundation Trust, Royal Sussex County Hospital, Brighton, BN2 5BE, UK.
Bhaskar GanaiDepartment of Radiology, University Hospitals Sussex NHS Foundation Trust, Royal Sussex County Hospital, Brighton, BN2 5BE, UK.
Dhiraj JoshiDepartment of Radiology, University Hospitals Sussex NHS Foundation Trust, Royal Sussex County Hospital, Brighton, BN2 5BE, UK.
Ben HudsonThe Exeter Liver Centre, Royal Devon and Exeter NHS Foundation Trust, Devon, EX2 5DW, UK.
Claire ButlerCentre for Health Services Studies, University of Kent, Canterbury, CT2 7 NZ, UK.
Alison RichardsonSchool of Health Sciences, University of Southampton, Southampton, SO17 1BJ, UK.
Mark WrightSchool of Health Sciences, University of Southampton, Southampton, SO17 1BJ, UK.
Wendy PrenticeDepartment of Palliative Care, Kings College Hospitals NHS Foundation Trust, London, SE5 9RS, UK.
Alastair O'BrienInstitute of Liver and Digestive Health, University College London, London, W1G 8EA, UK.
Joan BedlingtonPPI, LIVErNORTH, Durham, DH9 0SN, UK.
Shani SteerPPI Member, London, UK.
Tom GaskinPPI Member, London, UK.
Sumita VermaDepartment of Clinical and Experimental Medicine, Brighton & Sussex Medical School, University of Brighton and University of Sussex, Brighton, BN1 9PX, UK. s.verma@bsms.ac.uk.ORCID http://orcid.org/0000-0001-7021-8409

Funding

Health Technology Assessment Programme NIHR HTA 133889
6 · The paper itself

Abstract

backgroundAscites remains the most common complication of cirrhosis and a frequent reason for hospitalisation in advanced chronic liver disease (ACLD). Ascites is associated with significant symptom burden, caregiver workload and poor health-related quality of life (HRQoL). Once refractory to treatment, median survival is poor. Many with refractory ascites (RA) will neither receive a transjugular intrahepatic portosystemic shunt (TIPS) nor a liver transplant. Palliative care remains underutilised and evidence-based interventions focused on improving HRQoL are clearly needed. The standard of care for RA is repeated hospital ascites drainage with large volume paracentesis (LVP). Our earlier feasibility randomised controlled trial (RCT) (REDUCe) showed acceptability of palliative tunnelled long-term abdominal drains (LTADs), as well as preliminary evidence of safety and efficacy. The current REDUCe2 trial is a definitive national study designed to assess the impact of palliative LTADs on HRQoL in patients with RA due to ACLD. METHODS/

designThe REDUCe2 study is a pragmatic, multicentre, open-label, mixed-methods, superiority RCT being conducted in England, Scotland and Wales. Patients with RA secondary to ACLD who are ineligible for a liver transplant or TIPS will be randomised 1:1 to receive a LTAD or continue the current standard of care (LVP). Fortnightly home research visits will be conducted for 12 weeks in both arms. The primary outcome will be liver specific HRQoL assessed at 12 weeks using the Short Form Liver Disease Quality of Life questionnaire (SFLDQoL). Secondary outcomes include assessment of symptom burden (Ascites Questionnaire), health utilities (EQ-5D-5L tool), caregiver workload (Caregiver Roles and Responsibilities Scale-CRRS questionnaire), safety (including infection, acute kidney injury and other clinical outcomes), health resource utilisation and acceptability of the intervention by patients, caregivers and healthcare professionals. We aim to recruit a total of 310 patients (155 in each arm). DISCUSSION: Effective palliative care provision remains an unmet need in ACLD. The REDUCe2 study, the largest palliative interventional trial in the UK, aims to address this inequity for this vulnerable and underserved cohort. It has the potential to generate high quality evidence to optimise and enhance palliative care in RA.

trial registrationISRCTN26993825, date registered: 15/08/2022.

Indexed as

AscitesDrainageLiver CirrhosisPalliative CareParacentesisEnglandEquivalence Trials as TopicHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicQuality of LifeTime FactorsTreatment OutcomeAscitesCaregiversCost-effectiveness analysisEnd-stage liver diseasePalliative careParacentesisPatient reported outcome measuresQuality of life

Identifiers

PMID40468365
PMCPMC12139341

What OpenQuestion holds

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Registered trials

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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.