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    Interventional procedure overview of tunnelled peritoneal drainage catheter insertion of refractory ascites in cirrhosis

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    Safety summary

    Death

    Deaths (mainly liver related) were reported in 41% (7/17) of patients in the LTAD peritoneal-catheter group and 26% (5/19) of patients in the LVP group in the feasibility RCT of 36 patients. Five of these (3 in LTAD peritoneal-catheter and 2 in LVP group) happened within 4 weeks, and 4 deaths in each group happened outside the hospital (Macken 2021).

    Infections

    Bacterial peritonitis was reported in 17% (29/166) of patients in 16 studies, in the systematic review of 18 studies. Rates varied from 0% to 42% in individual studies. Excluding 1 outlier study (14 patients with catheter related organisms), the rate was 11% (15/133). Four of these patients had LTAD peritoneal catheters removed and had antibiotics. Eight patients had long-term prophylactic antibiotics and 1 had palliative care. The authors stated that the infections were no higher than what would be expected in people with ESLD. (Macken 2019).

    SBP was reported in 1 patient in the LTAD peritoneal-catheter group (n=17) and 2 patients in the LVP group (n=19) in the feasibility RCT of 36 patients. Treatment details were not reported (Macken 2021).

    In the RCT of 13 patients, all patients in the LTAD peritoneal-catheter group (n=6) developed colonisation of the catheter within 1 to 4 months but only 33% (2/6) of patients developed bacterial peritonitis. These patients withdrew from the study but had antibiotics and had intravenous albumin as part of treatment. In the LVP group (n=7), bacterial peritonitis was reported in 1 patient after rupture of an umbilical hernia and development of hepatorenal syndrome. The patient withdrew from the study. Infection of unknown origin was also reported in 1 patient in the same group (Kimer 2020).

    SBP after LTAD peritoneal-catheter insertion at a median 60 days (IQR 20 to 45 days) was reported in 63% (14/24) or patients in a retrospective review of 24 patients. These patients had antibiotics but 5 of them died (Elnagar 2020).

    Cellulitis

    Cellulitis at the catheter-insertion site was reported in 6% (9/147) patients with LTAD peritoneal catheters in the systematic review of 18 studies (Macken 2019).

    The rate of self-limiting cellulitis or leakage (that did not result in hospital admission) was higher in the LTAD peritoneal-catheter group compared with LVP group in the feasibility RCT of 36 patients (41% [7/17] compared with 11% [2/19]; Macken 2021).

    Non-infectious complications

    In the systematic review of 18 studies, non-infectious complications were reported in few studies and none were life threatening. These included:

    • minor transient hyponatraemia in 11% (16/142)

    • rise in creatinine in 8% (12/142)

    • leakage of ascites at access port-insertion sites in 8% (12/142)

    • catheter occlusion in 6% (8/142)

    • elevated serum urea (managed by reducing drainage episode frequency) in 2% (3/142)

    • accidental catheter displacement in 1% (2/142)

    • other events (AKI in 1, hematoma in 1, hepatic encephalopathy in 1, blood stained ascites post insertion in 1, bleeding that was self-resolved in 2) in 4% (6/142).

    Worsening renal function

    Worsening renal function happened in 35% (6/17) of patients in the LTAD peritoneal-catheter group and 37% (7/19) of patients in the LVP group in the feasibility RCT of 36 patients (Macken 2021).

    Accidental dislodgement of the catheter

    The catheter was accidentally pulled out (24 hours after insertion) in 1 patient in the LTAD peritoneal-catheter group in the feasibility RCT of 36 patients. The patient declined catheter reinsertion (Macken 2021).

    Detachment of the catheter from the subcutis (at 56 days) was reported in 1 patient in the LTAD peritoneal-catheter group (n=6) in the RCT of 13 patients. The patient withdrew from the study (Kimer 2020).

    Intestinal perforation

    Perforation of the ascending colon during implantation of an indwelling peritoneal catheter (and confirmed on CT) was reported in a case report of 1 patient with refractory ascites due to liver cirrhosis. The catheter was inserted to reduce intra-abdominal pressure and allow appropriate ventilation. An emergency laparotomy was done, the catheter was removed and perforation sites were sutured and closed. The patient died after 2 months because an irreversible malnutrition state resulted in a chronic respiratory failure (Paparoupa 2020).

    LTAD peritoneal-catheter removal

    LTAD peritoneal catheters were removed for various reasons in the retrospective review of 24 patients. In 67% (10/15) patients who developed SBP, catheters were removed at a median 10 days of antibiotics use. Other reasons for removal included leakage of the catheter in 8% (2/24) patients and blockage in another 8% (2/24) patients (Elnagar 2020).

    LTAD peritoneal-catheter replacement

    LTAD peritoneal catheters were replaced in 27% (4/15) of patients who developed SBP in the retrospective review of 24 patients. 3 of these patients developed recurrent SBP despite prophylaxis treatment (Elnagar 2020).

    Anecdotal and theoretical adverse events

    In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events that they have heard about) and about theoretical adverse events (events that they think might possibly occur, even if they have never happened).

    For this procedure, professional experts listed the following anecdotal adverse event: tunnel catheter being pulled out and causing strain to the tissue. They considered that the following were theoretical adverse events: injury to subcutaneous arteries leading to haemorrhage, leakage around the entry causing excoriation to skin.