Palliative long-term abdominal drains versus repeated drainage in untreatable ascites due to advanced cirrhosis: A randomised controlled trial (REDUCe 2 study)
Complications of cirrhosis
Current interventions as of 01/11/2023: Study design This RCT will follow on from the REDUCe feasibility study and will compare the insertion of a palliative tunnelled long-term abdominal drain (LTAD) (Group 1 intervention) to the standard of care (large volume paracentesis (LVP) (Group 2) in the management of refractory ascites due to advanced cirrhosis. This multi-centre, non-blinded parallel-group RCT with up to 3 months of follow-up will be conducted across 35 sites in England, Scotland and Wales. We aim to recruit 310 patients. 30 patients, 20 informal caregivers and 20 healthcare professionals will also be invited to give their perceptions/perspectives of LTAD and LVP using qualitative methods. The study will commence recruitment in October/November 2022 and is due to be completed in September 2026 which is the last patient last visit (LPLV). We have built in a 6-month lead-up time to secure HRA approvals and ensure all sites are set up and appropriate training provided. After the LPLV we have time to ensure the dataset is clean and locked for the statisticians to undertake the analysis. These timelines have been reviewed and approved by the funder: NIHR HTA. Participants will be approached by a member of the clinical team and provided with information about the study. The sample size has been calculated using HRQoL as the primary endpoint and the study will be conducted in a large number of sites in England and Scotland to ensure the sample size will be recruited in a timely manner. If they decide to proceed with the study they will be invited to the hospital for a screening visit. At this visit, consent will be received and blood will be taken for routine analysis and a sample of ascitic fluid will be taken to ensure there is no underlying infection. If there is this will be treated with oral antibiotics prior to any drain insertion. If the participant is eligible and they are willing to continue they will be randomised to either the Intervention (the LTAD)
Current inclusion criteria as of 04/12/2024: 1. Aged 18 years old and over 2. Refractory ascites due to cirrhosis (with the need for one or more LVP per month), defined as per International Ascites Club criteria (5-6): -Diuretic-resistant ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic treatment (spironolactone 400 mg and furosemide 160 mg) and or Diuretic-intractable ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of the development of diuretic-induced complications that preclude the use of an effective diuretic dosage 3. Registered with a GP in the community Trusts served by the participating centres. 4. Capacity to give informed consent. _____ Previous participant inclusion criteria as of 01/11/2023: 1. Aged 18 years old and over 2. Refractory ascites due to cirrhosis (with the need for one or more LVP per month), defined as per International Ascites Club criteria (5-6): 3. Diuretic-resistant ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic treatment (spironolactone 400 mg and furosemide 160 mg) and or Diuretic-intractable ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of the development of diuretic-induced complications that preclude the use of an effective diuretic dosage 4. Registered with a GP in the community Trusts served by the participating centres. _____ Previous participant inclusion criteria: 1. Aged 18 years old and over 2. Refractory ascites (with the need for one or more LVP per month), defined as per International Ascites Club criteria (5-6): 3. Diuretic-resistant ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction an
Current exclusion criteria as of 04/12/2024: 1. Loculated and or chylous ascites 2. 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 3. A candidate for liver transplantation and or TIPS 4. Psychosocial issues which in the opinion of the medical team will preclude study participation 5. Pregnancy - all women of childbearing age must have a negative pregnancy test 6. Lacks Capacity to give informed consent _____ Previous exclusion criteria: 1. Loculated and or chylous ascites 2. 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 3. A candidate for liver transplantation and or TIPS 4. Psychosocial issues which in the opinion of the medical team will preclude study participation 5. Pregnancy - all women of childbearing age must have a negative pregnancy test