Clinical trial NCT03191851: Evaluation of 'Melody' Paracentesis Device for Ascites Therapy
Official title: Evaluation of 'Melody' Paracentesis Device for Ascites Therapy in Patients With Cirrhosis (EMPATHY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ascites Hepatic
Cirrhosis and Chronic Liver Disease
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Mediplus Ltd UK
name: Enteric healthcare technology Co-operative
First posted: 2017-06-19
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ascites is the accumulation of fluid inside the abdomen. This can happen when the liver fails due to a substantial amount of scarring (cirrhosis). Patients (pts) must have this fluid drained and as cirrhosis progresses, patients will require drainage of ascites repeatedly on a regular basis, leading to frequent hospitals visits and increased complications.

The current drainage device is slow and doesn't always drain completely so pts have to return repeatedly to keep symptoms under control.

A new device (called Melody) has been developed and specifically designed for the purpose of draining ascites fluid, which the Investigators expect to drain faster and completely.

This study will compare the volume of ascites drained using the new 'Melody' catheter device with that used in standard NHS practice. If the melody catheter device is confirmed as superior to the current device this would improve patient experience (less frequent visits to hospital and increased length of time between visits).

With fewer procedures performed per patient, the pressure on the NHS would be greatly reduced in terms of time and costs.

Detailed description: Large volume paracentesis has been established as a treatment for symptomatic ascites and is performed regularly in secondary care hospitals widely across the UK.

Lack of a device specifically designed to perform paracentesis means that flow of ascites fluid through the catheter is not optimal leading to incomplete drainage and hence, frequent repeated paracentesis as well as a number of complications.

A new 'Melody' catheter device has been designed and developed in collaboration with Mediplus Ltd and NIHR Enteric Bowel function Healthcare Technology Co-operative; specifically designed to improve the performance characteristics of paracentesis procedure.

(The 'Melody ascites drainage catheter' including 'sterile ascetic drainage sets' is CE marked for clinical use). In addition, investigators would also like to confirm whether the addition of a pump will improve drainage with this device further.

The Investigators propose to carry out a feasibility study, 'EMPATHY', with an aim to compare the performance characteristics of 'Melody' catheter device (with and without addition of 'Andromeda' pump) with the current device. 112 patients with ascites requiring therapeutic paracentesis will be randomised to undergo the procedure using one of the two devices. The volume of ascites drained per session will be compared along with ease of insertion and removal as well as patient experience including all adverse events up to 7 days following the procedure. The outcomes of this feasibility study will inform further refinement of the 'Melody' catheter device as well as a future large multi-centre randomised controlled trial evaluating the cost-effectiveness of the new 'Melody' catheter device in therapeutic paracentesis

Eligibility criteria: Inclusion Criteria:

* Ascites due to cirrhosis of the liver.
* Aged 18-80 years.
* Ability to give written consent.

Exclusion Criteria:

* Known untreated spontaneous bacterial peritonitis.
* Disseminated intravascular coagulation at the time of consenting.
* Pregnancy.
* Patients who have had more than six ascitic drainage procedures.

Primary outcomes:
measure: Amount of ascites fluid drained (litres)
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Queen Day Case Unit Nottingham University Hospitals NHS Trust
Study officials:
affiliation: NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust & University of Nottingham
name: Guruprasad Aithal
role: PRINCIPAL_INVESTIGATOR
References: