Rocket® Pleural Catheters: QOL, Feasibility and Satisfaction in Recurrent MPE Patients

Ottawa Hospital Research Institute

Status: Unknown

Conditions: Malignant Pleural Effusion

Treatments: Device: Rocket® IPC- Short External Length; Device: Rocket® IPC- Long External Length

Study type: Interventional

Funder types: Other

Identifiers

NCT03403855

20170753-01H

Details and patient eligibility

About

This study will take place in Ottawa, Ontario, and will include 100 patients who are receiving tunnelled pleural catheters to treat their symptoms of MPE. The aim of this study is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural catheter in managing malignant pleural effusions in terms of patients' self-rated quality of life, its ease of use, the incidence of complications, and levels of health care provider satisfaction.

Full description

Pleural effusion is a medical condition, which occurs when too much fluid collects in the space between the lungs and the chest wall. This extra fluid makes it hard for the lungs to fully expand and take in enough air when inhaling. Malignant pleural effusions (MPE) are effusions related to cancer. Common symptoms of MPE include: dyspnea (shortness of breath), cough, weight loss, and chest pain. Tunneled pleural catheters (which are inserted into the body) are now commonly used to treat the symptoms of malignant pleural effusions by draining this extra fluid on a daily basis. This drainage can be done and home and need not be performed at a hospital.

The aim of this study is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural catheter in managing malignant pleural effusions in terms of patients' self-rated quality of life, its ease of use, the incidence of complications, and levels of health care provider satisfaction. The Rocket® pleural catheter has been approved by the Food and Drug Administration (FDA) and Health Canada for the management of malignant pleural effusions.

This study will take place in Ottawa, Ontario, and will include 100 patients who are receiving tunnelled pleural catheters to treat their symptoms of MPE. All information required to evaluate the Rocket® catheter will be collected from routine medical follow-up visits. The period of time for the study is approximately 4 weeks (28 days).

The Rocket® catheter will be provided to patients who wish to participate in this study. If patients do not wish to participate, they will receive the current standard of care (the PleurX catheter) and will undergo the same standard medical assessments that will be performed in this study.

All patients eligible for the study will have a regular full length Rocket catheter inserted at baseline, with an external length of 16cm. All patients will have their catheter length modified at 2 weeks in clinic and shortened to an external length of 5cm.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Presence of symptomatic (BDI < 6), and moderate sized (> 1/3 of hemithorax) MPE
2. Persistent malignant pleural effusion that is free flowing
3. Life expectancy of at least 2 months (approximate duration of follow-up for the study)
4. Age greater than 18
5. Consent to undergoing TPC treatment for recurrent MPE

Exclusion criteria

1. Prior attempted chemical pleurodesis on ipsilateral side
2. Active pleural or pulmonary infection
3. Currently hospitalized for reasons other than MPE or in hospice care
4. Life expectancy estimated at less than 2 months
5. Inability to complete questionnaires (English or French)
6. Refusal to give informed consent
7. Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Rocket® IPC- Long External Length

Experimental group

Description:

Intervention Rocket® IPC- Long External Length: a regular full length (long catheter) Rocket catheter inserted at baseline, with an external length of 16cm. Catheter length will be modified at 2 weeks in clinic, shortened to an external length of 5cm (short catheter). Patient satisfaction will be collected at 2 weeks prior to the modification, and at 4 weeks when the patient has a shorter catheter. The modification is easily done without any use of anesthesia as it is external to the patient using the tool kit that comes along with the catheter. Patients will be referred to palliative home care services for assistance with drainage. The drainage catheters to be used in this study will be samples supplied by Rocket Medical Inc., for Dr. Amjadi to evaluate their product.

Treatment:

Device: Rocket® IPC- Long External Length

Rocket® IPC- Short External Length

Experimental group

Description:

Intervention Rocket® IPC- Short External Length : a regular full length (long catheter) Rocket catheter inserted at baseline, with an external length of 16cm. Catheter length will be modified at 2 weeks in clinic, shortened to an external length of 5cm (short catheter). Patient satisfaction will be collected at 2 weeks prior to the modification, and at 4 weeks when the patient has a shorter catheter. The modification is easily done without any use of anesthesia as it is external to the patient using the tool kit that comes along with the catheter. Patients will be referred to palliative home care services for assistance with drainage. The drainage catheters to be used in this study will be samples supplied by Rocket Medical Inc., for Dr. Amjadi to evaluate Rocket's product.

Treatment:

Device: Rocket® IPC- Short External Length