Quality of Life of Patients Who Have Rocket Indwelling Pleural Catheter Drainage or Repeated Large Volume Paracentesis

NCT03550690 | Unknown

• 2 other identifiers: Rocket Project 1242415
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ascites (accumulation of fluid in the abdominal cavity) is a common problem which can lead to distressing symptoms. When caused by cancer, management options are chemotherapy, diuretics and ascitic drainage. Ascitic drainage is performed by inserting a plastic tube into the abdomen and draining off the fluid under local anaesthetic, removing the drain afterwards. For some, the fluid will return and the procedure needs repeating. A relatively new treatment involves inserting a semi-permanent drain - a small plastic tube under the skin which is left in place so that the fluid can be drained if it builds up again. The potential benefit to patients is that afterwards they can have fluid removed at home. This might reduce the number of hospital admissions, outpatient visits and the number of procedures they need to have in the last few months of life. In Gloucestershire, the Rocket Indwelling Pleural Catheter (IPC) is the semi-permanent drain of choice. Our research group has a particular interest in the management of ascites and we recently completed the first qualitative interview study with patients with this condition - patients with ascites secondary to cancer. Patients were pleased to have semi-permanent drains in place as it meant that repeated admissions to hospital were avoided. They did not have to wait for a build-up of fluid before more could be drained off; and symptoms never had to build up as badly as when they were having repeated ascitic drainage. We plan a feasibility study to ascertain whether a definitive non-randomised study to detect differences in quality of life between Rocket IPC and repeat ascitic drainage is possible and how many patients would be needed for such a study.

Conditions

Ascites, Malignant

Outcome Measures

Primary Outcomes (1)

• Percentage presence and percentage completeness of the three QOL measures

  3 months

Secondary Outcomes (8)

• Number of LVPs / Rocket IPC drainage episodes performed

  3 months

• Volumes of fluid removed at LVPs OR number of Rocket IPC bottles used at Rocket IPC drainage

  3 months

• Complications

  3 months

• The Edmonton Symptom Assessment System:Ascites Modification (ESAS:AM) DAILY

  3 months

• The EuroQol questionnaire (EQ-5D) as a generic QOL measure DAILY

  3 months

Study Arms (2)

Large Volume Paracentesis

Patient has repeated large volume paracentesis for recurrent ascites secondary to cancer

Device: Large Volume Paracentesis

Semi-permanent drain

Patient has a semi-permanent drain (Rocket Indwelling Pleural Catheter) placed for recurrent ascites secondary to cancer

Device: Rocket Indwelling Pleural Catheter

Interventions

Large Volume Paracentesis DEVICE

Insertion of a plastic tube into the abdomen and draining off ascitic fluid under local anaesthetic, removing the drain afterwards

Large Volume Paracentesis

Rocket Indwelling Pleural Catheter DEVICE

A small plastic tube under the skin which is left in place so that the fluid can be drained if it builds up again

Semi-permanent drain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

See above

You may qualify if:

• Male or female adult patients
• Have ascites due to cancer undergoing treatment at Gloucestershire Hospitals NHS Foundation Trust
• Planned to have an ascitic tap within a week
• Thought to have an estimated prognosis of 12 weeks or more
• Willing and able to provide signed written informed consent

You may not qualify if:

• Patients who, in the opinion of the clinical team, would be too distressed by the idea of participation.
• Patients who might not adequately understand verbal explanations or written information given in English.
• Adult supporting patient participant in Rocket Project 1
• Happy to support patient with completion of patient diaries
• Relatives who, in the opinion of the clinical team, would be too distressed by the idea of participation.
• Relatives who might not adequately understand verbal explanations or written information given in English.

Sponsors & Collaborators

• Gloucestershire Hospitals NHS Foundation Trust: lead

Related Publications (2)

• Day R, Mitchell T, Keen A, Perkins P. The experiences of patients with ascites secondary to cancer: a qualitative study. Palliat Med. 2013 Sep;27(8):739-46. doi: 10.1177/0269216313480400. Epub 2013 Apr 4.

  PMID: 23558342 BACKGROUND

• Easson AM, Bezjak A, Ross S, Wright JG. The ability of existing questionnaires to measure symptom change after paracentesis for symptomatic ascites. Ann Surg Oncol. 2007 Aug;14(8):2348-57. doi: 10.1245/s10434-007-9370-3. Epub 2007 May 16.

  PMID: 17505860 BACKGROUND

MeSH Terms

Conditions

Ascites

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Paul Perkins, MB BCh

CONTACT

+441242230199; paul.perkins@suerydercare.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Palliative Medicine

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 8, 2018
• Study Start: September 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share