None listed
Conditions
Brief summary
Chronic liver diseases, from any aetiology, progress over time to cirrhosis if untreated. Ascites-related readmissions are the predominant cause of hospitalisations in these patients, especially in the last few months of life. Large volume paracentesis is the only therapeutic option in those who cannot undergo LT. LVPs are typically performed every week or two in medical day-care units (MDU) as elective procedures, or as emergency hospital admissions. There are practical difficulties in organising LVPs due to bed limitations in the medical day-care unit, and this situation often leads to emergency room presentations and hospitalisations. Since ascites drainage in patients unsuitable for LT is a palliative procedure, it is best done in the comfort of their homes on a regular basis. This study explores the possibility of an alternative procedure via a catheter inserted in the abdomen and repeated small-quantity drainages (simply, long-term abdominal drains or LTADs).
Interventions
Determine the suitability of long term abdominal drains (LTAD) in managing ascites. Upon consent, participants will have a LTAD inserted into their abdomen in hospital by a trained interventional radiologist. Participants will be admitted overnight under the Hepatology unit. Rocket® LTAD catheters (Rocket Medical, Watford, UK) will be inserted in the angiography suite by interventional radiologists using a combination of Seldinger and tunnelling procedure as stated in the Rocket information sheet (Rocket Medical. Indwelling Peritoneal Catheter (IPC) Insertion Kit R54400–16-40. As part of standard of care within the Hepatology Unit, all participants undergoing an invasive procedure will be assessed for their risk of bleeding during admission. Based on prior standard of care bloods, INR and platelet counts will be assessed by the clinical team to determine if additional tests are required (INR=1.5 OR Platelet count =50,000). If required, on the day of admission for LTAD insertion, participants will have a blood sample collected for rotational thromboelastometry (ROTEM) testing as per standard of care. ROTEM testing can predict the risk of thrombosis and bleeding in liver disease patients. This standard of care process will be explained to the participant at admission by the liver team. If an abnormal ROTEM result is present, the participant will receive blood products guided by the ROTEM algorithm practised in the unit prior to their invasive procedure. As per the ROTEM algorithm participants will receive FFP, cryoprecipitate and/or platelets as required. Participants will be observed overnight and a complete ascitic drain will be done via LTAD prior to discharge. At discharge, participants will be provided with an information kit (specifically designed for the study) and details of when the at-home drains will begin. A referral will also be made prior to discharge to the Metropolitan Referral Unit indicating frequency of drains (how many times a week) and a community nurse will coordinate the times to attend with patient. . All participants will be prescribed antibiotics (if not already on them, norfloxacin 400 mg once a day or equivalent) for the duration of the study to avoid the risk of infection. Participant will be provided with the drain supplies on discharge for community nurses to use. Drains will be dependent on the participant's clinical need, with drains up to 3-4 times a week with a maximum of 2L of ascitic fluid drained at home (1hr appointments) by the community care nurses. On arrival, the community nurse will complete an assessment of the patient as per their normal routine i.e. observations. Next, the community nurse, using a Rocket 2000ml drainage bag pack, will remove patients dressing, attach the drainage bag and conduct the drain with up to 2000ml of ascitic fluid to be drained over a time of 10-30minutes. The drainage bag is then disconnected and a new dressing reapplied – all completed as per protocol. The study specific diary will also be completed, documenting patients weight, amount drained and time drainage took. Participants will be followed up weekly by the chronic liver disease nurses (10mins phone call), and have a monthly follow-up in clinic (20 minutes) with their treating doctor and the chronic liver disease nurse. The intervention (at-home drains) will be for 6mths.
Sponsors
Study design
Eligibility
Inclusion criteria
Age >18 years with capacity to consent for treatment Patient with mild cognitive impairment, at treating doctor and/or PI’s discretion Refractory ascites Ascites that is unresponsive to fluid and sodium restriction, and high-dose diuretic treatment (spironolactone 400 mg/day and/or furosemide 160 mg/day) with or without intolerance to diuretics Ascites that recurs rapidly after LVP (requiring one or more LVP/month). Considered ineligible to undergo LT and or trans jugular intrahepatic portosystemic shunts (TIPSS)
Exclusion criteria
Patients with loculated ascites Patients with large exophytic liver tumours Patients with chronic abdominal pain Patients with extensive abdominal wall scars Patients unlikely to tolerate with abdominal drains at home as judged by the treating medical team Patients with active spontaneous bacterial peritonitis