Condition category
Digestive System
Date applied
07/10/2015
Date assigned
07/10/2015
Last edited
19/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Cirrhosis is a serious complication of liver disease, which involves widespread scarring of the liver. The damage to the liver caused by cirrhosis means that eventually the liver is unable to fulfil its normal functions, ultimately leading to liver failure. Cirrhosis develops gradually, however the damage to the liver is irreversible, and gets worse over time. When cirrhosis is so advanced that the liver is unable to function, a liver transplant is the only treatment option. If a person with advanced cirrhosis does not meet the requirements for a liver transplant, then they are unlikely to survive for longer than six months. One of the most common complications of advanced cirrhosis is a build-up of fluid in the abdomen (ascites). Ascites can be very uncomfortable and make it difficult to breathe and eat properly. The only way to relieve these symptoms is by having the excess fluid drained through a small cut in the abdomen. Despite this, the fluid immediately starts to build-up again, and so patients have to attend hospital every one-two weeks to have the draining procedure repeated. Draining fluid in this way can be very expensive, as well as causing pain and infection. In some advanced cancers, ascites are managed by having a more permanent drain placed into the abdomen (long-term abdominal drain). This means that smaller amounts of fluid can be drained more often in the patients’ own home. Repeated hospital admission can cause distress and so being able to manage aspects of their treatment at home may be an attractive prospect for advanced cirrhosis patients. The aim of this study is to look into the possibility of using long-term abdominal drains for treating ascites in advanced cirrhosis patients.

Who can participate?
Adults with advanced cirrhosis who have untreatable ascites.

What does the study involve?
Patients are randomly allocated into two groups. Those in the first group receive standard care, which involves repeated drainage in hospital. Those in the second group have a long-term abdominal drain implanted, so that the fluid build-up can be drained several times a week. This takes place in the patients’ own homes and the process is supported by community nurses. Health and wellbeing of the patients in both groups are monitored for a period of three months. The impact of the different care methods on the patients’ families and carers is also assessed.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Brighton & Sussex Clinical Trials Unit

When is the study starting and how long is it expected to run for?
October 2015 to May 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Miss Justine Boles

Trial website

Contact information

Type

Scientific

Primary contact

Miss Justine Boles

ORCID ID

Contact details

Brighton & Sussex Clinical Trials Unit
16 Bloomsbury Street
Brighton
BN2 1HQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19235

Study information

Scientific title

Palliative long-term abdominal drains versus repeated drainage in individuals with untreatable ascites due to advanced cirrhosis: a feasibility randomised controlled trial.

Acronym

Study hypothesis

The aim of this study is to investigate the acceptability and feasibility in using long term abdominal drains to treat patients with cirrhosis.

Ethics approval

15/SC/0257

Study design

Randomised; Interventional and Observational; Design type: Treatment, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Gastroenterology; Subtopic: Gastroenterology; Disease: All Gastroenterology

Intervention

Patients will be randomly allocated to one of two groups:

Group 1: Patients receive current standard care only (hospital based abdominal drainage)
Group 2: Patients have a drain implanted into the abdominal area so that fluid can be drained at home.

Community (district) nurses (and, if identified as required, specialist community palliative care teams) will support the patients. Patients will be monitored over three months to assess symptoms and quality of life and the impact on family/carers. Likely costs to the NHS of the new technique will be calculated.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Acceptability of LTAD to patients/carers and staff to be measured at end of study (3 months) or at the time of patient death, which ever occurs first.

Secondary outcome measures

N/A

Overall trial start date

01/10/2015

Overall trial end date

30/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Presence of untreatable (refractory) ascites, defined as:
2.1. Ascites that are unresponsive to fluid and sodium restriction and high dose diuretic treatment (spironolactone 400 mg and or furosemide 160 mg) and/or intolerance of diuretics
2.2. Recurs rapidly after LVP (need for one or more LVP per month).
3. Child Pugh Score of greater than 9. unless specifically decided by the medical team that they are to receive only palliative treatment. If less than 9, the participant is considered palliative by medical team.
4. 4. Registered with a GP in Brighton and Hove or West Sussex with community Integrated Primary Care Team provision from Sussex Community NHS Trust
5. Ability to speak read and understand English
6. Capacity to give informed consent as defined using the Capacity to Consent Checklist
7. Signed, informed consent prior to any study specific procedures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 48; UK Sample Size: 48

Participant exclusion criteria

1. Either loculated or chylous ascites
2. Presence of > grade 1 hepatic encephalopathy (specified by West Haven Criteria – appendix 13)
3. Evidence of active infection that in the investigator’s opinion would preclude insertion of LTAD (for example, bacterial peritonitis) – such patients would need to receive appropriate treatment and could then be reconsidered
4. A candidate for liver transplantation
5. Psychosocial issues which in the opinion of the medical team will preclude study participation

Recruitment start date

01/10/2015

Recruitment end date

30/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Brighton & Sussex Clinical Trials Unit
16 Bloomsbury Street
Brighton
BN2 1HQ
United Kingdom

Sponsor information

Organisation

Brighton and Sussex University Hospitals NHS Trust

Sponsor details

Village Way
Falmer
Brighton
BN1 9PH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes