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    Efficacy summary

    Technical success

    In a systematic review of LTAD peritoneal catheters for refractory ascites in ESLD (n=18 studies), technical insertion of the catheter was successful in 100% of patients (Macken 2019).

    Place of ascites management (subsequent drainage)

    In the systematic review of LTAD peritoneal catheters, 9 studies reported ascites management at home, either by community nurses, patients themselves or caregivers. Three studies reported management in either a hospice or the patient's home and 2 reported management either in a hospital outpatient setting or the patient's home. Four studies did not state the place of ascites management (Macken 2019).

    In a feasibility RCT of 36 patients with RA caused by ESLD comparing 17 patients with LTAD peritoneal catheters (and fortnightly home visits) and 19 patients with LVP, ascites drainage at home by nurses and carers was reported in 67% (10/15) patients in the LTAD peritoneal-catheter group. The median number of visits per week for drainage was 1.9 (IQR 0.6 to 2.5) in this group (Macken 2021).

    In an RCT of 13 patients with RA caused by ESLD comparing 6 patients with LTAD peritoneal catheters and 7 patients with LVP, drainage at home was reported in 6 patients. Vacuum bottles were used in amounts of 2 litres per drainage, with a median interval of 2 to 5 days. One patient needed LVP after 56 days because of clotting in the catheter (Kimer 2020).

    Further hospital admissions needing ascites drainage

    In the systematic review of LTAD peritoneal catheters, no further hospital admissions were needed in 14 studies that reported drainage following LTAD peritoneal-catheter insertion. Hospital admission for full drainage with intravenous albumin was needed for 2 patients in 1 study and for 3 patients in another study (for unrelated conditions; Macken 2019).

    In the feasibility RCT of 36 patients, further drainage at hospital was needed in 5 patients each in the LTAD peritoneal-catheter (n=17) and LVP (n=19) groups. However, this was mainly for non-ascites related problems (Macken 2021).

    Median number of hospital ascitic-drainage catheters

    In the feasibility RCT of 36 patients, the median number of hospital ascitic-drainage catheters was 5 before randomisation in both groups. This reduced to 0 (IQR 0,1) in the LTAD peritoneal-catheter group and 4 (IQR 3,7) in LVP group at 12-week follow up. (Macken 2021).

    Specialist palliative care support

    In the systematic review of 18 studies, 12 studies reported that LTAD peritoneal-catheter insertion was done as a palliative procedure. Five studies used LTAD peritoneal catheters in patients having long-term and non-long-term care. Three studies took input from specialist palliative care (Macken 2019).

    Duration LTAD peritoneal catheter remained in place

    In the systematic review of 18 studies, how long LTAD peritoneal catheters remained in place varied across studies. Median LTAD peritoneal-catheter duration reported in 9 studies ranged between 6 weeks to 8 months (Macken 2019).

    Patient survival after LTAD peritoneal-catheter insertion

    In the systematic review of 18 studies, median patient survival varied across studies. In 6 studies it ranged between 29 days to 6 months (Macken 2019).

    In the feasibility RCT of 36 patients, median survival at 12 weeks was 53% (9/17) in the LTAD peritoneal-catheter group and 63% (12/19) in the LVP group. Median survival in patients who died was 53 days in LTAD peritoneal-catheter group and 61 days in LVP group (Macken 2021).

    Biochemical outcomes

    In the feasibility RCT of 36 patients, serum albumin (g/litre) decreased from baseline to 12 weeks in both the groups (from median of 33 g/litre to 29 g/litre in the LTAD peritoneal-catheter group compared with 31 g/litre to 30 g/litre in the LVP group). Patients in the LTAD peritoneal-catheter group did not routinely have human albumin solution. Serum creatinine (micromol/litre) decreased from 109.5 micromol/litre to 104.5 micromol/litre in the LTAD peritoneal-catheter group but increased from 113.5 micromol/litre to 127 micromol/litre in the LVP group (Macken 2021).

    In the RCT of 13 patients, a moderate fall in plasma albumin levels was seen in the LTAD peritoneal-catheter group compared with the LVP group (p=0.07, median decrease in albumin in LTAD peritoneal catheter group was 4 g/litre). Intravenous albumin had no clear influence on the albumin levels. No statistically significant changes in plasma sodium (p=0.14) or creatinine levels (p=0.67) were seen in the groups (Kimer 2020).

    Symptom control (questionnaire assessment)

    In the feasibility RCT of 36 patients, median physical symptoms, emotional symptoms, communication scores and total IPOS scores (assessed using the IPOS questionnaire with 17 items and scores ranging from 0 to 68) remained consistent in both the LTAD peritoneal-catheter and LVP groups during 12 weeks of follow up (Macken 2021).

    QOL

    In the systematic review of 18 studies, 1 study assessed QOL (using a questionnaire similar to the Chronic Liver Disease Questionnaire) after LTAD peritoneal-catheter insertion. All patients reported improvements in mobility and daily activities. Nursing staff also stated that it 'benefited and supported earlier placement' (Macken 2019).

    In the feasibility RCT of 36 patients, generic health-related quality of life measured on the EQ-5D-5L VAS (range 0 [worst] to 100 [best]) showed a trend towards improvement in the LTAD peritoneal-catheter group (from baseline 57.6 to 66.3 at 12 weeks). The EQ‑5D‑5L index (5 dimensions scored on a 5-point scale; -0.59 [worst] to 1 [best]) worsened in the LTAD peritoneal-catheter group (from baseline 0.65 to 0.59 at 12 weeks)but there was some improvement in the LVP group (from baseline 0.52 to 0.57 at 12 weeks). Liver-specific health-related QOL, using the SFLDQoL questionnaire ( was better in the LTAD peritoneal-catheter group than the LVP group at baseline in all domains except hopelessness. During follow up at 12 weeks, scores decreased in the LTAD peritoneal-catheter group but increased in most domains in the LVP group.

    Caregiver burden assessed using ZBI-12 scores (0 [never best] to 48 [nearly worst]) remained stable in the LTAD peritoneal-catheter group. There was an increasing trend (that is, worsening carer burden) in the LVP group (from baseline 14.6 to 20 at 12 weeks). Macken 2021).

    In the RCT of 13 patients, the median CAS score indicated that QOL was poor at baseline (LTAD peritoneal catheter 19 points and LVP 21 points) and there was no statistically significant difference between the groups during the course of the trial (Kimer 2020).

    Acceptability

    In the feasibility RCT of 36 patients, 6 of the nurses and 14 of the patients (6 in LTAD peritoneal-catheter and 8 in LVP group) interviewed showed that LTAD peritoneal catheters transformed the care pathway and improved symptom control (Macken 2021).