Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management (OPTIMUM)

Guy's and St Thomas' NHS Foundation Trust

Status: Completed

Conditions: Pleural Effusion, Malignant

Treatments: Device: Indwelling Pleural Catheter Insertion and Talc Pleurodesis; Device: Chest Drain Insertion and Talc Pleurodesis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02517749

RJ115/N175

Details and patient eligibility

About

This is a multicentre randomised controlled trial evaluating global health related quality of life outcomes in patients with malignant pleural effusions. Patients will be randomised to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc pleurodesis. Patients will be followed up for 3 months post intervention

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of malignant pleural effusion
2. WHO performance status 2 or less unless performance status is impaired by presence of effusion and likely to significantly improve with drainage
3. Expected survival greater than 3 months

Exclusion criteria

1. Age less than 18 years old

2. Pregnant or lactating

3. Known allergy to Talc or Lignocaine

4. Lack of symptomatic relief from effusion drainage

5. At least twice weekly drainage cannot be undertaken

6. Lymphoma or small cell carcinoma except*:

   1. Failure of chemotherapy
   2. Deemed for palliative management

7. Non malignant effusions

8. Loculated pleural effusion

9. Unable to provide written informed consent to trial participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Usual Care Group

Active Comparator group

Description:

Patients in this group will be managed as per the British Thoracic Society guideline for management of malignant pleural effusions. They will undergo chest tube insertion and undergo Talc pleurodesis with 4g of SteriTalc

Treatment:

Device: Chest Drain Insertion and Talc Pleurodesis

Indwelling Pleural Catheter Group

Active Comparator group

Description:

Patients in this group will undergo Indwelling Pleural Catheter (IPC) insertion. This will be inserted as per standard practice. They will undergo Talc pleurodesis via the IPC with 4g SteriTalc

Treatment:

Device: Indwelling Pleural Catheter Insertion and Talc Pleurodesis