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Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis

Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis
Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis

BACKGROUND: Palliative care remains suboptimal in end-stage liver disease.

AIM: To inform a definitive study, we assessed palliative long-term abdominal drains in end-stage liver disease to determine recruitment, attrition, safety/potential effectiveness, questionnaires/interview uptake/completion and make a preliminary cost comparison.

METHODS: A 12-week feasibility nonblinded randomised controlled trial comparing large-volume paracentesis vs long-term abdominal drains in refractory ascites due to end-stage liver disease with fortnightly home visits for clinical/questionnaire-based assessments. Study success criteria were attrition not >50%, <10% long-term abdominal drain removal due to complications, the long-term abdominal drain group to spend <50% ascites-related study time in hospital vs large-volume paracentesis group and 80% questionnaire/interview uptake/completion.

RESULTS: Of 59 eligible patients, 36 (61%) were randomised, 17 to long-term abdominal drain and 19 to large-volume paracentesis. Following randomisation, median number (IQR) of hospital ascitic drains (long-term abdominal drain group vs large-volume paracentesis group) were 0 (0-1) vs 4 (3-7); week 12 serum albumin (g/L) and serum creatinine (μmol/L) were 29 (26.5-32.5) vs 30 (25-35) and 104.5 (81-115.5) vs 127 (63-158) respectively. Total attrition was 42% (long-term abdominal drain group 47%, large-volume paracentesis group 37%). Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital were lower in the long-term abdominal drain group, £329 (253-580) vs £843 (603-1060) and 0% (0-0.74) vs 2.75% (2.35-3.84) respectively. Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively. Questionnaires/interview uptake/completion were ≥80%; interviews indicated that long-term abdominal drains could transform the care pathway.

CONCLUSIONS: The REDUCe study demonstrates feasibility with preliminary evidence of long-term abdominal drain acceptability/effectiveness/safety and reduction in health resource utilisation.

TRIAL REGISTRATION: ISRCTN30697116, date assigned: 07/10/2015.

Aged, Ascites/blood, Creatinine/blood, Drainage, End Stage Liver Disease/blood, Female, Humans, Liver Cirrhosis/blood, Male, Middle Aged, Palliative Care, Serum Albumin
0269-2813
107-122
Macken, Lucia
c0b55ca2-e7f7-4602-b214-121fd5ea82d8
Bremner, Stephen
0e117fa6-27ea-41cc-9523-70f90cd65bc0
Gage, Heather
19bfbcaf-5cec-4ca4-8830-53216e56a460
Touray, Morro
0e3a94f1-1296-43f8-bd7d-b9a59a2063bc
Williams, Peter
ade5fc98-0f00-4c0a-85dd-050da1537fcd
Crook, David
fefa21b8-2f53-498f-b1b9-b19af681ed3e
Mason, Louise
355cd8e7-d35c-4b46-a4d5-02a7c307ac9c
Lambert, Debbie
d546ee55-d845-4212-80bf-5d1bda5951b3
Evans, Catherine J
7873b7bb-40e9-48f3-a16c-539d8c50249e
Cooper, Max
235d6109-240f-41a4-9696-deea8da539ed
Timeyin, Jean
51dbd184-e7e4-42b1-800c-12b2b470a4f0
Steer, Shani
3366a933-22dd-473a-b70d-bd09492bb7ff
Austin, Mark
2f973763-c457-4a7b-965f-27d5e58c327d
Parnell, Nick
304e80fe-c8f0-4ffc-8ddf-c6e079b0fecc
Thomson, Sam J
be7de5c4-c7da-483c-a6af-c03ba3b585de
Sheridan, David
f5d3d0db-03da-44dc-8d0f-c7548b4997d4
Wright, Mark
43325ef9-3459-4c75-b3bf-cf8d8dac2a21
Isaacs, Peter
b02b91c8-54f8-4a8d-bc6a-d41fe1142d7b
Hashim, Ahmed
1d9645cf-9ef7-463b-b4b8-892e8abe9b33
Verma, Sumita
201a9d04-a18b-41ed-b199-57e2aa18222d
Macken, Lucia
c0b55ca2-e7f7-4602-b214-121fd5ea82d8
Bremner, Stephen
0e117fa6-27ea-41cc-9523-70f90cd65bc0
Gage, Heather
19bfbcaf-5cec-4ca4-8830-53216e56a460
Touray, Morro
0e3a94f1-1296-43f8-bd7d-b9a59a2063bc
Williams, Peter
ade5fc98-0f00-4c0a-85dd-050da1537fcd
Crook, David
fefa21b8-2f53-498f-b1b9-b19af681ed3e
Mason, Louise
355cd8e7-d35c-4b46-a4d5-02a7c307ac9c
Lambert, Debbie
d546ee55-d845-4212-80bf-5d1bda5951b3
Evans, Catherine J
7873b7bb-40e9-48f3-a16c-539d8c50249e
Cooper, Max
235d6109-240f-41a4-9696-deea8da539ed
Timeyin, Jean
51dbd184-e7e4-42b1-800c-12b2b470a4f0
Steer, Shani
3366a933-22dd-473a-b70d-bd09492bb7ff
Austin, Mark
2f973763-c457-4a7b-965f-27d5e58c327d
Parnell, Nick
304e80fe-c8f0-4ffc-8ddf-c6e079b0fecc
Thomson, Sam J
be7de5c4-c7da-483c-a6af-c03ba3b585de
Sheridan, David
f5d3d0db-03da-44dc-8d0f-c7548b4997d4
Wright, Mark
43325ef9-3459-4c75-b3bf-cf8d8dac2a21
Isaacs, Peter
b02b91c8-54f8-4a8d-bc6a-d41fe1142d7b
Hashim, Ahmed
1d9645cf-9ef7-463b-b4b8-892e8abe9b33
Verma, Sumita
201a9d04-a18b-41ed-b199-57e2aa18222d

Macken, Lucia, Bremner, Stephen, Gage, Heather, Touray, Morro, Williams, Peter, Crook, David, Mason, Louise, Lambert, Debbie, Evans, Catherine J, Cooper, Max, Timeyin, Jean, Steer, Shani, Austin, Mark, Parnell, Nick, Thomson, Sam J, Sheridan, David, Wright, Mark, Isaacs, Peter, Hashim, Ahmed and Verma, Sumita (2020) Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis. Alimentary pharmacology & therapeutics, 52 (1), 107-122. (doi:10.1111/apt.15802).

Record type: Article

Abstract

BACKGROUND: Palliative care remains suboptimal in end-stage liver disease.

AIM: To inform a definitive study, we assessed palliative long-term abdominal drains in end-stage liver disease to determine recruitment, attrition, safety/potential effectiveness, questionnaires/interview uptake/completion and make a preliminary cost comparison.

METHODS: A 12-week feasibility nonblinded randomised controlled trial comparing large-volume paracentesis vs long-term abdominal drains in refractory ascites due to end-stage liver disease with fortnightly home visits for clinical/questionnaire-based assessments. Study success criteria were attrition not >50%, <10% long-term abdominal drain removal due to complications, the long-term abdominal drain group to spend <50% ascites-related study time in hospital vs large-volume paracentesis group and 80% questionnaire/interview uptake/completion.

RESULTS: Of 59 eligible patients, 36 (61%) were randomised, 17 to long-term abdominal drain and 19 to large-volume paracentesis. Following randomisation, median number (IQR) of hospital ascitic drains (long-term abdominal drain group vs large-volume paracentesis group) were 0 (0-1) vs 4 (3-7); week 12 serum albumin (g/L) and serum creatinine (μmol/L) were 29 (26.5-32.5) vs 30 (25-35) and 104.5 (81-115.5) vs 127 (63-158) respectively. Total attrition was 42% (long-term abdominal drain group 47%, large-volume paracentesis group 37%). Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital were lower in the long-term abdominal drain group, £329 (253-580) vs £843 (603-1060) and 0% (0-0.74) vs 2.75% (2.35-3.84) respectively. Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively. Questionnaires/interview uptake/completion were ≥80%; interviews indicated that long-term abdominal drains could transform the care pathway.

CONCLUSIONS: The REDUCe study demonstrates feasibility with preliminary evidence of long-term abdominal drain acceptability/effectiveness/safety and reduction in health resource utilisation.

TRIAL REGISTRATION: ISRCTN30697116, date assigned: 07/10/2015.

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More information

Published date: 1 July 2020
Additional Information: © 2020 John Wiley & Sons Ltd.
Keywords: Aged, Ascites/blood, Creatinine/blood, Drainage, End Stage Liver Disease/blood, Female, Humans, Liver Cirrhosis/blood, Male, Middle Aged, Palliative Care, Serum Albumin

Identifiers

Local EPrints ID: 478101
URI: http://eprints.soton.ac.uk/id/eprint/478101
ISSN: 0269-2813
PURE UUID: 520d218c-cb7a-4792-a1d8-c54d69fcb8ee

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Date deposited: 21 Jun 2023 16:56
Last modified: 21 Jun 2023 16:56

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Contributors

Author: Lucia Macken
Author: Stephen Bremner
Author: Heather Gage
Author: Morro Touray
Author: Peter Williams
Author: David Crook
Author: Louise Mason
Author: Debbie Lambert
Author: Catherine J Evans
Author: Max Cooper
Author: Jean Timeyin
Author: Shani Steer
Author: Mark Austin
Author: Nick Parnell
Author: Sam J Thomson
Author: David Sheridan
Author: Mark Wright
Author: Peter Isaacs
Author: Ahmed Hashim
Author: Sumita Verma

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