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

NCT03550690 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2018-06-11

No results posted yet for this study

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

Interventions

DEVICE

Large Volume Paracentesis

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

DEVICE

Rocket Indwelling Pleural Catheter

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

Sponsors & Collaborators

  • Gloucestershire Hospitals NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2019-07-31
Completion
2019-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03550690 on ClinicalTrials.gov