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Long term abdominal drains in end stage cirrhosis

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30697116
Enrollment
48
Registered
2015-10-07
Start date
2015-10-01
Completion date
Unknown
Last updated
2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Gastroenterology

Interventions

Patients will be randomly allocated to one of two groups: Group 1: Patients receive current standard care only (hospital based abdominal drainage) Group 2: Patients ha

Sponsors

Brighton and Sussex University Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Acceptability of LTAD to patients/carers and staff to be measured at end of study (3 months) or at the time of patient death, which ever occurs first.

Secondary

MeasureTime frame
There are no secondary outcome measures.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 6, 2026