Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06682936

Can Talc Pleurodesis for Malignant Pleural Effusion be Performed on an Ambulatory Basis

Led by David Rollins · Updated on 2024-11-12

15

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating a new way to treat patients with malignant pleural effusion, a condition where fluid builds up around the lungs causing breathlessness. The study aims to see if talc pleurodesis, a procedure to stop fluid buildup that usually requires hospital stay, can be safely done on an outpatient basis to improve quality of life. The study also collects patient feedback on the acceptability of this approach. Participants will have a chest drain inserted on the first day to remove fluid using a standard underwater seal bottle. The drain is clamped and opened repeatedly to remove fluid throughout the day before being connected to an ambulatory bag for the patient to go home. On the second day, fluid output is assessed, and if appropriate, talc slurry with lidocaine is instilled to prevent fluid return. The drain remains connected to the ambulatory bag as patients return home. On the third day, further fluid drainage and chest x-rays determine if the drain can be removed and the treatment completed. During the study, patients complete brief questionnaires about breathlessness, chest pain, and satisfaction with the procedure at multiple times on days 1 to 3 and again at day 30. Researchers will monitor the success of delivering the ambulatory talc pleurodesis protocol, patient satisfaction, and safety through chest x-rays and follow-up. The entire treatment and observation span about five days with ongoing follow-up after completion.

CONDITIONS

Brief Title

Feasibility of Ambulatory Talc. Pleurodesis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Malignant pleural effusion
  • Life expectancy greater than 30 days
  • World Health Organization performance status 1-2 (or 3 if due to dyspnea)
Not Eligible

You will not qualify if you...

  • Previous failed pleurodesis on the affected side
  • Known non-expansile lung

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 days

Participants have a chest drain inserted and fluid is drained over several days on an ambulatory basis. Talc pleurodesis is instilled if the lung has fully expanded. Participants return home with an ambulatory bag and come back for daily drainage and assessments.

Daily visits on Days 1, 2, and 3 (in-person)

Follow-up

Duration - 30 days

Participants complete a brief questionnaire on breathlessness, chest pain, satisfaction with the procedure, and preferences about hospital stay.

1 visit (in-person) on Day 30

Trial Site Locations

Total: 1 location

1

North Tees and Hartlepool NHS foundation trust

Stockton-on-Tees, County Durham, United Kingdom, TS19 8PE

Actively Recruiting

Loading map...

Research Team

K

Kevin Conroy, MBBS, FRCP

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

Similar Trials

A Phase 1 Single Arm, Dose Escalation Study to Evaluate the ...

Advanced Malignant Solid Tumor

Actively Recruiting

1 location

Effects of a Structured, Family-supported, Patient-centred A...

Palliative Care

Actively Recruiting

3 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here