Complications of cirrhosis Digestive System
Conditions
Interventions
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)
Sponsors
University of Sussex
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 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 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver-specific health-related quality of life (HRQoL) measured using the short-form-liver disease quality of life (SFLDQoL) questionnaire at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cumulative incidence of peritonitis in the LTAD and LVP groups measured using standard laboratory methods at 12 weeks. Peritonitis defined as ascitic white cell count > 500 cells/mm3, and/or neutrophil count > 250 cells/mm3 and/or a positive ascitic fluid culture. 2. Ascites-related symptoms measured using the Ascites Q questionnaire at baseline and weeks 2, 4, 6, 8, 10 and 12 3. Workload impact on the caregiver assessed using the Caregiver Roles and Responsibilities Scale (CRRC) at baseline and weeks 4, 8 and 12 4.1. Health Resource Utilisation measured using the modified Ambulatory and Home Care Record (AHCR) for community service use at baseline and weeks 4, 8 and 12 4.2. Hospital service use measured using the Hospital Service use in-house designed questionnaire (to be completed by a member of the research team) at the week 12 visit 4.3 Cost-utility measured using the EQ-5D-5L questionnaire to generate adjusted life years (QALYs) at baseline and weeks 2, 4, 6, 8, 10 and 12 | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactAlison Porges
Outcome results
None listed