Summary of key evidence on Long term tunnelled peritoneal drainage catheter insertion for palliation of refractory ascites in cirrhosis

Study 1 Macken L (2019)

Study details

Study type	Systematic review
Country	UK
Search details	Search from inception to 2018; databases searched: MEDLINE, EMBASE, CINAHL, Google Scholar and Cochrane Database of Systematic Reviews. Hand searching of journals, reference lists and conference abstracts was also done.
Study population and number	n=18 studies (176 patients) with PIPC in refractory abdominal ascites due to ESLD (or cirrhosis) (12 full papers and 6 conference abstracts included) 3 prospective, 7 retrospective cohort studies; 1 retrospective cohort study with matched controls; 5 case series, 1 case report and 1 RCT protocol (PIPC versus LVP). Indications: RA due to CLD (n=10 studies, 2 included both ascites and hepatic hydrothoracies), ascites due to cirrhosis, malignancy and other aetiologies (n=8 studies).
Age and sex	NR
Study selection criteria	Inclusion criteria: studies in English, all types of study designs, adult patients (>18 years) who had PIPC for recurrent drainage of RA due to ESLD in palliative management. Studies including both CLD and non‐CLD aetiologies for ascites. Exclusion criteria: studies with paediatric patients, with only hepatic hydrothoracies, patients without CLD, animal studies, shunting devices (including peritoneovenous, TIPSS) and ALFApump, papers reporting solely on malignant ascites and/or patients having chemotherapy, duplicate publications.
Technique	PIPCs used: 1. permanent indwelling (tunnelled) peritoneal catheters in 12 studies (9 PleurX™, 1 Rocket® and 2 unspecified catheters) 2. permanent subcutaneous port with intra‐abdominal catheter in 3 studies (Celsite Drainport in 1, port-a-cath peritoneal implantable system in 1 and unspecified catheter in 1) and 3. permanent tunnelled peritoneal dialysis catheters in 3 studies (1 Tenckhoff catheter and 2 unspecified catheters). Insertion method: 10 were done under ultrasound guidance; 1 under ultrasound and fluoroscopic guidance, 1 using X‐ray guidance and 1 was inserted surgically (Tenckhoff catheter). 2 studies did not report insertion methods. Procedure was performed by interventional radiologists (8 studies), interventional nephrologists (2 studies) and consultant physicians/gastroenterologists (2 studies), and trained physicians (1).
Follow up	NR
Conflict of interest/source of funding	None to declare. Authors received funding from National Institute for Health Research (NIHR) under its research for patient benefit Programme, Kent Surrey and Sussex Deanery, Dunhill Medical Trust, and Gilead Medical Sciences.

Study design issues: systematic review conducted as per PRISMA guidelines (Preferred Reporting Items for Systematic reviews and Meta‐Analyses). Comprehensive search method and strategy was used, 2 authors screened and selected studies and extracted data, the quality of non‐randomised studies was assessed using the Newcastle‐Ottawa Scale (NOS). Studies were small of low quality with different study designs, indications and groups, and reported on different indwelling catheters. Cases of hepatic hydrothoracies were excluded from the analysis.

Data on the severity of liver disease (Child-Pugh and/or MELD scores were reported in only 10 studies), patient and catheter related survival and prior history of SBP were limited and in‐ consistent. There was significant heterogeneity in prophylactic antibiotic regimens and use. QOL was assessed but pre-intervention questionnaire was not available for comparison.

Study population issues: studies reported between 1 to 33 patients.

Key efficacy findings

Number of patients analysed: 176 patients (18 studies)

Technical insertion success: 100%

Use of prophylactic antibiotics: 9 studies reported the use of peri‐procedural antibiotics (2 of the studies used in limited cases during insertion procedure), 3 of these studies and another 2 studies reported use of long term prophylactic antibiotics. 7 studies reported that no prophylactic antibiotics were used.

Place of subsequent drainage/ascites management: 9 studies reported ascites management at home either by community nurses, patients themselves or care givers; 3 reported in either a hospice or patient's home and 2 reported either in a hospital outpatient setting, or the patients' home. 4 studies did not state the place of ascites management. Hospital admission for full drainage with intravenous albumin cover was needed for 2 patients in 1 study and 3 patients in another study (for unrelated conditions).

Specialist palliative care support 12 studies reported that PIPC was performed as a palliative procedure. 5 studies used PIPC in patients on long term care and non-long term care. 3 studies took input from specialist palliative care.

Patient survival after PIPC insertion and duration PIPC remained in situ

Study	N	Patient survival post insertion	Duration PIPC remained in situ
Ahmed 2018 (RCT protocol)	1	6 months	NR
Corrigan 2018 (conference abstract, published and in appendix)	24	6 months (50%) 12 months (25%)	NR
Hingwala 2017 (cohort study)	8	NR	Median 146 days (IQR 33.5-1039 days)
Imler 2018 (conference poster)	16	3 months (60.2%) 6 months (38.5%)	NR
Knight 2017 (cohort study)	3	Median 85 days	NR
Kriese 2013 (conference poster)	4	NR	Median 30 days (IQR 20-50)
Kundu 2012 (conference poster)	12	NR	Median 2 months
Lungren 2013 (cohort study)	7	NR	Mean 60 days (IQR 0-796 days)
Macken 2016 (case series)	7	Median 29 days (IQR 8-219)	NR
Monsky 2009 (cohort study)	2	NR	NR
Po 1996 (conference poster)	1	Mean 6 months	NR
Reinglas 2016 (cohort study)	33	NR	Median 117.5 days
Reisfield 2003 (case report)	5	6 weeks/until death	Mean 6 weeks
Riedel 2018 (cohort study with controls)	7	Mean 200 days	NR
Rosenblum 2001 (case series)	9	NR	Mean 255 days
Savin 2005 (cohort study)	4	NR	1810 days
Semadeni 2015 (conference poster)	9	Mean 192 days	Mean 111 days
Solbach 2017 (cohort study)	24	NR	Mean 83.2 days

Duration PIPC remained in situ duration of PIPC in situ varied across studies. Median PIPC duration reported in 9 studies ranged between 6 weeks to 8 months.

Median patient survival also varied across studies. In 6 studies it ranged between 29 days to 6 months.

QOL 1 study assessed QOL (using a questionnaire similar to the Chronic Liver Disease Questionnaire) after PIPC insertion. All patients reported improvements in mobility and daily activities. Nursing staff also stated that it 'benefited and supported earlier placement'.

Key safety findings

Adverse events and complications (n=16 studies)

Infections	% (n)
Bacterial peritonitis	17 (29/166)* IQR 0-42%
Bacterial peritonitis (excluding 1 study as an outlier)	11 (15/133)**
Cellulitis at catheter insertion site^	6 (9/147)
Other complications in patients with ESLD
Minor transient hyponatraemia	11 (16/142)
Rise in creatinine	8 (12/142)
Leakage of ascites at insertion sites (access port site)	8 (12/142)
Catheter occlusion	6 (8/142)
Elevated serum urea (managed by reducing drainage episode frequency)	2 (3/142)
Accidental catheter displacement	1 (2/142)
Others (AKI, haematoma, hepatic encephalopathy of unknown cause, blood stained ascites post insertion) 2 bleeding complications were self-resolved.	3 (1/142)
Complications in studies with mixed RA aetiology
"catheter malfunction" unspecified	n=5
ascites leakage at incisional site (requiring suture placement)	n=5
temporary occlusions (patency restored using tPA infusion)	n=3
self‐limiting ecchymosis	n=3
Complications without RA aetiology
ascites leakage at catheter insertion site	n=13
unspecified catheter malfunctions	n=5
occluded catheters (3 peritoneal ports with patency restored after administration of tissue plasminogen activator (tPA)	n=5
accidental catheter displacements	n=4
Groin pain	n=2
Abdominal pain	n=1
undiagnosed loculated ascites (due to port failure)	n=1

*14 of these patients in 1 study had catheter related organisms in routine cultures and of uncertain clinical significance.

**4 had PIPC removed and had antibiotics; 8 had antibiotics with PIPC left in situ; 1 was palliated as was end of life, in 2 no subsequent management was described.

^4 mixed cohort studies reported 11 patients with either cellulitis or "local infection"; but underlying aetiology was not reported, therefore they were not included in analysis.

There were no device related deaths.

Study 2 Macken L (2021), Cooper M (2021)

Study details

Study type	Feasibility RCT (REDUCe study ISRCTN30697116)
Country	UK
Recruitment period	2015-2018
Study population and number	36 patients with refractory ascites due to ESLD 17 with long-term abdominal drains (LTAD) versus 19 with LVP.
Age	Mean 66.3 years in LTAD group versus mean 67.9 years in LVP group. LTAD 76% (13/17) male versus LVP 74% (14/19) male
Patient selection criteria	Inclusion criteria: ascites that recurred rapidly after LVP (a minimum of 2 LVPs), requiring 1 or more LVPs/month, age > 18 years, CPS > 9 (unless felt to be palliative despite lower CPS) and capacity to give informed consent. Exclusion criteria: loculated or chylous ascites, > grade 1 hepatic encephalopathy, active infection (SBP) and eligible for liver transplantation.
Technique	LTAD insertion was done in hospital as a day procedure under local anaesthesia and ultrasound guidance. Patients, caregivers, community nursing teams, and primary care physicians were provided guidance on LTAD use. The community nurses did home visits 2-3 times/week, draining 1-2 litres of ascitic fluid at each visit. No human albumin solution was administered. LVP was done in day units or hospital (as per local practice). A peritoneal drain was inserted for up to 6 hours for ascites drainage and intravenous human albumin solution administered (8g -10g per litre of ascitic fluid removed). Antibiotic prophylaxis (ciprofloxacin 500 mg once a day) was offered to all LTAD and LVP patients for the study duration.
Follow up	12 weeks; median 82 versus 86 days
Conflict of interest/source of funding	Study funded by National Institute for Health Research. Rocket Medical provided the LTAD free of cost for the trial but were not involved in the study design.

Analysis

Follow-up issues: high attrition rate, 42% (15/36) patients were lost to follow-up (3 withdrew from study, 12 died outside hospital within 4 weeks [7 in the LTAD group and 5 in the LVP group]). Overall, 9 patients in LTAD group and 12 patients in LVP group completed the study.

Study design issues: feasibility non-blinded RCT across 5 centres (50% patients from 1 centre) with small target sample size. Patients were identified at day-case units or at hospital admissions; randomised to intervention or standard of care using a web based system and allocations were shown after registering a patient. Study success criteria were attrition not >50%, < 50% ascites-related study time in hospital versus LVP group and 80% completion of questionnaire/interviews, <10% LTAD removal because of complications.

Clinical/questionnaire-based assessments were done fortnightly during home visits by research team and recorded electronically. Symptoms were assessed using the IPOS questionnaire, and QOL was assessed using the SFLDQoL questionnaire, the EuroQol 5 dimensions instrument and carer-reported Zarit 12 questionnaire. For qualitative study, telephone interviews were conducted, data recorded, transcribed verbatim, and analysed using thematic analysis.

Study population issues: The prevalence of hepatic encephalopathy, alcohol aetiology for ESLD and BMI were higher in the LTAD group. Serious comorbidities (n=25, 69%), prior hepatic encephalopathy (n=9, 26%), Child-Pugh C disease (n=7, 20%), hepatocellular cancer (n=6, 18%) and serum creatinine >1.5ULN (n=6, 17%) were reported in some patients.

Key efficacy findings

Number of patients analysed: 17 LTAD versus 19 LVP
All LTADs were inserted successfully.

Ascites drainage

	LTAD (n=17)	LVP (n=19)
Median amount of ascitic fluid drained/week (litres)	3.85 (IQR 2.85 to 4.51)	4.42 (IQR 3.00 to 6.09)
Median number of visits per week for drainage	1.9 (IQR 0.6 to 2.5)	0.33 (IQR 0.17 to 0.5)
Ascites drainage outside hospital /at home (by nurses/carers)	67% (10/15)
Further drains at hospital /day unit	33% (5/15) 13 drains (5 non-ascites related, 8 in day unit)	69 drains (64 in day unit, 5 in hospital but 4 were non-ascites related)
Median number of ascitic drains	Before randomisation 5 (IQR 3 -8)	Before randomisation 5 (4, 7)
	After randomisation 0 (0,1)	After randomisation 4 (3, 7)

Biochemical outcomes

	LTAD (n=17)	LVP (n=19)
Serum albumin (g/litre), median (IQR)
Baseline	33(33, 36)	31 (29, 34)
Week 12	29 (26.5, 32.5)	30 (25, 35)
Serum creatinine (micromol/litre) (median, IQR)
Baseline	109 (79. 141)	113.5 (89, 134)
Week 12	104.5 (81, 115.5)	127 (63, 158)
Serum bilirubin (micromol/litre)
Baseline	22 (15, 37)	23 (17, 48)
Week 12	17	26

Median survival

	LTAD (n=17)	LVP (n=19)
Median survival at 12 weeks (% (n)	53% (9/17)	63% (12/19)
Median survival in those who died (days)	53 (range 27 to 70)	61%(range 26 to 61)

Patient reported outcomes (questionnaire based assessment)

	n/N	LTAD (mean±SD)	n	LVP (mean±SD)	Mean difference (95% CI)
EQ 5D-5L index
Baseline	17	0.65±0.30	18/19	0.52±0.28
12 weeks	8/9	0.59±0.15	12/12	0.57±0.24	0.02 (-0.18, 0.22)
EQ-5D-5L VAS
Baseline	17	57.6 ±26.7	18/18	54.1± 23.4
12 weeks	8/9	66.3 28.1	12/12	55.7± 20.8	10.6 (-0.9.2, 30.4)
Zarit Burden Interview 12
Baseline	9	17.9± 9.4	8	14.6± 8.4
12 weeks	3	18.0± 11.5	5	20.0± 3.7	-2.0 (-15.1, 11.1)
IPOS -physical
Baseline	17	10.6± 7.2	18/19	15.6± 5.8
12 weeks	8/9	14± 6.4	12/12	15.3± 7.6	-1.3 (-8.1, 5.6)
IPOS-emotional
Baseline	16/17	6.9± 3.2	18/19	6.6± 3.4
12 weeks	8/9	6.5± 5.1	12/12	4.5± 2	1.6 (-1.4, 5.4)
IPOS-communication
Baseline	17	2.4±2.9	18/19	2.4±2.6
12 weeks	8/9	2.4±2.4	12/12	1.8±2.1	0.6 (-1.5, 2.7)
IPOS -patient (total)
Baseline	16/17	19.2±8.9	18/19	24.5±9.8
12 weeks	8/9	22.9±10.8	12/12	21.5±8.9	-2.7 (-8.6, 3.1)
SFLDQoL (range 0 to 100; higher scores better)
Symptoms
Baseline	17	64.5± 19.8	18/19	49.8± 23.1
12 weeks	8/9	54.6± 21.2	10/12	53.3± 20.7	1.3 (-19.7, 22.2)
Effect
Baseline	15/17	58.9± 23.5	17/19	50.5± 24.2
12 weeks	8/9	61.5± 27.8	10/12	60.4± 26.7	1.0 (-26.3, 28.4)
Memory
Baseline	17	74.6± 23.3	18/19	67.0± 27.9
12 weeks	8/9	64.8± 28.7	10/12	74.4± 19.9	-9.5 (-33.8, 14.7)
Distress
Baseline	17	47.1± 39.7	18/19	37.5± 30.0
12 weeks	8/9	35.9± 39.8	10/12	58.8± 32.8	-22.8 (-59.0, 13.4)
Sleep
Baseline	17	57.4± 22.2	18/19	36.0± 21.9
12 weeks	8/9	45.0± 14.1	10/12	41.5± 15.1	3.5 (-11.3, 18.3)
Loneliness
Baseline	17	67.1± 19.3	18/19	72.8± 31.5
12 weeks	8/9	51.9± 30.1	10/12	89.0± 15.6	-37.1 (-60.4, -13.9)
Hopelessness
Baseline	17	50.0± 26.5	18/19	43.1± 24.6
12 weeks	8/9	29.2± 27.1	10/12	48.3± 17.9	-19.2 (-41.7, 3.4)
Stigma
Baseline	17	66.4± 28.7	18/19	61.8± 24.2
12 weeks	8/9	60.9± 28.1	10/12	64.4± 24.3	-3.4 (- 29.6, 22.7)
Sexual function
Baseline	17	Not available	19	Not available
8 weeks	2/13	4.4± 0.1	3/14	2.4± 1.7

n/N number of patients completing questionnaires /number alive at each visit.

Increasing EQ-5D-5L scores indicate better health outcome.

Increasing IPOS and ZB1-12 scores indicate higher symptom and carer burden respectively.

Increasing SFLDQoL scores indicate better QoL.

Acceptability of LTAD (qualitative study)

14 patients (6 in LTAD and 8 in LVP group) and nurses (n=6) interviewed indicated that LTADs can transform the care pathway for ESLD as a palliative option by enabling care at home, improved symptom control of ascites, personalised care and regular support from community nurses. 5 out of 8 patients in the LVP arm expressed disappointment in not being randomised to the LTAD arm. Nurses expressed the need for additional support if this becomes standard of care (Cooper M 2021).

Key safety findings

	LTAD, n	LVP, n
Serious adverse events
Death	7	5
Stroke	1
Fall	1
Hospital acquired pneumonia	1	1
Hepatic hydrothorax	1	1
SBP	1	2
Worsening renal function	2	1
Hyperkalaemia	1	1
Worsening HE	1
Acute gastroenteritis	1
Umbilical hernial leakage	1
Abdominal pain		1
Hospital admission after LVP		1
Leg fracture		1
Variceal bleed		2
Adverse event (minor, self-limiting, none needing hospitalisation)
Abdominal pan	5	4
Nausea, vomiting, diarrhoea, and constipation	7	8
Urinary tract infection	2	1
Sacral/vaginal/penis pain/ skin laceration	6	9
Lower respiratory tract/chest infection	3	1
Falls	6	4
Hoarse voice	1
Oesophageal candida	1
Pruritis	1	1
Hypotension	1	1
Anaemia/GI bleed	2	4
Hyperkalaemia/ hyponatremia	3	2
Worsening renal function	4	6
Cellulitis /leakage at drainage site	7
Hepatic encephalopathy	3
Worsening oedema /breathlessness	2
Drain accidentally pulled out (24hrs after insertion, declined reinsertion)	1
Mouth ulcers		2
Epistaxis		2
Increased ferritin		1
Cough/reflex		3
Positive blood culture		1
Bleeding leakage after LVP		2
Increasing bilirubin		1
Fever		1
Hospice admission		1
Hypoglycaemia		2
Umbilical hernia blister		1

Study 3 Kimer N (2020)

Study details

Study type	RCT (NCT03027635 PETRA)
Country	Denmark
Recruitment period	2017-2018
Study population and number	N= 13 patients with cirrhosis and ascites 6 with PIPC versus 7 with LVP and albumin infusion.
Age	Median 68 years (IQR 48 to 77 years); 54% (7/13) male.
Patient selection criteria	Inclusion criteria: adults with cirrhosis and non-malignant recurrent ascites (refractory to medical treatment and with complications) and expected survival of more than 3 months. Exclusion criteria: eligible for TIPS insertion, hepatic encephalopathy or variceal bleeding within 2 weeks, ongoing infection, intraabdominal surgery within 4 months, an increased risk of complications as judged by the healthcare provider.
Technique	PIPC : PleurX (BD Carefusion, UK) tunnelled peritoneal catheter is inserted in 6 patients to allow drainage of ascites < 2 litre per day) in the patients' own home using vacuum containers by home nurses. LVP and albumin infusion done as per clinical guidelines in 7 patients. paracentesis was performed whenever needed throughout the study period, with intervals between 5 and 14 days. Procedures were done under local anaesthesia and x ray/ultrasound guidance by hepatologists. All patients had antibiotics daily. An additional puncture next to the catheter was performed when bacterial colonization was suspected.
Follow up	6 months (median 181 days in LVP group versus 127 days in PleurX group)
Conflict of interest/source of funding	BD Carefusion supported this trial with PleurX bottles and catheters. Study was funded by a grant from Amager-Hvidovre Hospital and from Copenhagen University International Fund. Authors declared that they either received funding for research, lecture fees from companies or served as member of advisory board.

Analysis

Follow-up issues: high attrition rate (1 patient in the PleurX group developed complications before the procedure, 1 patient in each group died, 2 patients in each group withdrew from study because of serious adverse events). Overall, 8/13 patients completed the study.

Study design issues: very limited number of patients were included; randomisation was computer generated and allocation was concealed by using opaque sealed envelopes. Primary outcome was paracentesis free survival. QOL was assessed at baseline and monthly using the CAS score (a 14-item scale assessing ascites related symptoms, with score ranges from 14 to 40, and the higher the score, the worse the burden of symptoms). Patients were monitored for infections and all culture positive samples were repeated after 14 days for verification.

Study population issues: 11 patients had recurrent ascites despite diuretic treatment. At baseline, all patients needed LVP with 6–14 days intervals.

Other issues: the study intended to recruit more patients but was terminated early because of slow recruitment in patients with end stage liver disease and other comorbidities. Many patients did not meet inclusion criteria.

Key efficacy findings

Number of patients analysed: 6 LTAD versus 7 LVP

Paracentesis free survival

4 patients in each group completed the trial at a median follow-up of 181 days in LVP group and 127 days in LTAD group.

Changes in biochemical outcomes

A moderate fall in plasma albumin levels was observed in the LTAD group compared to the LVP group (median decrease in albumin in LTAD group was 4 g/litre, p=0.07). Intravenous albumin had no clear influence on the albumin levels. No significant changes in plasma sodium (p=0.14) or creatinine levels (p=0.67) were observed during the study period.

Number of paracentesis

Paracentesis In the LVP group: first paracentesis was at 6 to 20 days. During follow-up, patients needed LVP with a median interval of 13 days (range 8–16). The median number of LVPs ranged from 4 to 35 and the median dose of albumin administered at each LVP was 2 portions of 20 g (range 0–4 portions of 20 g).

Paracentesis In the LTAD group: 1 patient needed LVP after 56 days because of clotting of the catheter. The remaining patients had drainage at home using vacuum bottles in amounts not exceeding 2 litre per drainage, with a median interval of 2-5 days. 5 patients in the LTAD group had intravenous albumin for hypotension in 2 patients, hyponatremia in 1 patient and as part of the treatment of SBP in 2 patients. The total median dose of albumin administered was 2 portions of 20 g (range 2–4 portions of 20 g).

QOL

The median CAS score indicated that QOL was poor at baseline (LTAD 19 points and LVP 21 points) and there was no significant difference between the groups during the study period.

Key safety findings

	LTAD group (n=6)	LVP (n=7)
Procedure related complications	0	0
Mortality
Terminal liver failure	1
Head trauma injury		1
Adverse events
Variceal bleeding		1
Sepsis (patient in LTAD group withdrew before catheter insertion)	1^	2
Hyponatremia (due to frequent use of catheter in 1)	2
Bacterial peritonitis (infections occurred within 1-4 months and had antibiotics)**	2	1*
Infection of unknown origin		1
Hepatic encephalopathy	1	2*
Hepatorenal syndrome (in the patient with sepsis in LTAD group)	1	2*
Hypokalaemia	1
Detachment of the catheter from the subcutis (at 56 days, patient withdrew from study)	1^
Erysipelas		1

^in the LTAD group, 2 patients withdrew from study (1 patient with sepsis and hepatorenal syndrome before catheter insertion and 1 after catheter detachment at 2 months).

*In the LVP group, 2 patients withdrew from study (1 patient with prolonged admission for hepatorenal syndrome and hepatic encephalopathy, 1 patient with bacterial peritonitis after rupture of umbilical hernia).

**In the LTAD group, all patients colonised the catheter but 2 developed bacterial peritonitis. The most common bacterial colonisation was Staphylococcus Epidermidis (n = 4/6).

Study 4 Paparoupa M (2020)

Study details

Study type	Case report
Country	Germany
Recruitment period	NR
Study population and number	N=1 patient with refractory ascites due to cirrhosis of the liver admitted to the intensive care unit because of severe community-acquired pneumonia and implanted with a tunnelled peritoneal drainage catheter.
Age	68 year old male
Patient selection criteria
Technique	Permanently-tunnelled catheter was placed percutaneously (ASEPT® Peritoneal Drainage System, 15.5 F 5.2 mm×71 cm). The procedure was done under ultrasonographic guidance.
Follow up	12 weeks median 82 versus 86 days
Conflict of interest/source of funding	Authors declare they have no competing interests.

Key safety findings

Ascending colon perforation during implantation of a tunnelled peritoneal drainage catheter

After permanent catheter implantation clear ascites was drained initially but a few hours later, peritoneal fluid could not be removed and bowel content was detected. An abdominal CT confirmed perforation of the ascending colon and the catheter has been passed through the bowel wall and re-entered the peritoneal cavity. No peritonitis or pneumoperitoneum occurred. An emergency laparotomy was performed, catheter was removed and perforation sites were sutured and closed. Patient also had a TIPSS, to manage portal hypertension. However, a relaparotomy with right hemicolectomy was done on the second day, as an insufficiency of the previously sutured perforation sites occurred. The patient died after 2 months in intensive care, as an irreversible malnutrition state resulted in chronic respiratory failure.

Study 5 Elnagar M (2020)

Study details

Study type	Conference abstract (retrospective review)
Country	UK
Recruitment period	2009-2019
Study population and number	N=24 patients had LTAD for refractory ascites. Ascites was secondary to liver cirrhosis in 22 patients and heart failure/cardiac cirrhosis in 2 patients. Median MELD score was 14(range 6–32). Median number of LVP in 6 months before LTAD insertion was 5 (range 0–15), with median interval of 2 weeks. SBP before LTAD treated in 7 patients, 6 remained on prophylaxis.
Age	17/24 male
Patient selection criteria	NR
Technique	LTAD (Rocket catheter) inserted under ultrasound guidance by experienced interventional radiologists.
Follow up	6 months
Conflict of interest/source of funding	Not declared

Key safety findings

Complications following LTAD insertion

Complications	% (n=24)
SBP after LTAD insertion (at median 60 days [range 20-45 days]). Treated with antibiotics	62.5% (15/24) ( 5 of these died)
LTAD removal
SBP (after median 10 days of antibiotics)	67% (10/15)
LTAD replacement and prophylaxis	27% (4/15)
Recurrent SBP	3/4
Leakage	8% (2/24)
Blockage	8% (2/24)

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