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CompletedNCT06682936ClinicalTrials.gov record

Feasibility of Ambulatory Talc. Pleurodesis

Malignant Pleural Effusion · Malignancy · Palliative Care

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
15 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Patients with malignant pleural disease often experience a significant symptom burden and a short life expectancy. The cornerstone of their treatment is relieving breathlessness by draining fluid from around the lungs and attempting to prevent further fluid build up. Inpatient chest drainage and talc pleurodesis remains the most successful method of stopping the fluid build up but this often requires an average hospital stay of four days. This can be an inappropriate length of time for this patient group. Our study would investigate whether this treatment could be provided on an outpatient, ambulatory basis and facilitate a greater quality of life.

The investigators would assess deliverability of the trial protocol and collect patient feedback to see if our patients consider it an acceptable and worthwhile intervention.

Read the full description

Eligible patients will be offered enrolment in the trial along with standard of care options.

Participants who agree to take part in the trial would be consented for chest drain, talc pleurodesis on an ambulatory pathway.

On day 1 a standard chest drain would be inserted in the morning and large volume fluid removal would commence using an underwater seal bottle- as per standard care. A chest x-ray would be undertaken to confirm drain position, as per standard care. The investigators would remove 1000mls of fluid (stopping earlier if not tolerated) and the clamp the drain for one hour. The investigators would then open the drain again and drain up to 500mls before again clamping for one hour. The investigators would repeat this process as frequently as possible until the end of the working day. The drain would then be connected to an ambulatory bag instead of the underwater seal bottle and left in the open position. The patient would then be sent home to return on day 2.

On day 2 the drain would be flushed, aspirated and the output assessed. If there is still fluid output the investigators would drain up to 500mls and close the drain for an hour and repeat. If there is no further output the investigators would undertake a chest x ray to ensure the effusion has resolved and the lung has fully inflated. If it has the investigators would proceed to talc slurry instillation (with 20mls 1% lidocaine as per standard practice) and clamp the drain for 2 hours. After this the investigators would open the drain again and drain up to 500mls and close the drain for an hour. The investigators would repeat this as required and again the patient would return home with an ambulatory bag left open.

If the effusion has resolved but the lung has not fully expanded due to underlying disease then the investigators would simply remove the chest drain as pleurodesis will not be possible.

On day 3 the drain would be flushed, aspirated and the output assessed. If there is still fluid output the investigators would drain up to 500mls and close the drain for an hour and repeat. If there is no further output the investigators would undertake a chest x ray to ensure the effusion has resolved and the lung has fully inflated. the investigators would then remove the drain and repeat the x-ray to confirm there have been no complications. the investigators would then consider the intervention complete and revert to standard care (open access follow up )

If there was still significant fluid output the investigators would repeatedly drain 500ml volumes of fluid and clamp the drain for an hour after each 500ml until dry.

The investigators would ask patients to complete a very brief questionnaire (visual analogue scale) on breathlessness and chest pain on day 1 - before intervention, 1 hour post drain insertion, at the end of the day and on day 2 and 3 on first encounter and at the end of the day. The investigators would also repeat the questionnaire on day 30 along with their satisfaction with the procedure and if participants would have preferred to have stayed in hospital for the procedure (and why)

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • Malignant pleural effusion
  • Life expectancy \>30 days
  • WHO PS 1-2 (3 if due to dyspnoea)

Exclusion Criteria:

  • Previous failed pleurodesis (on affected side)
  • Known non-expansile lung
Understand screening

Treatment, groups and participation

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Assignment
Not applicable
Masking
No masking
outpatient drain and talc pleurodesis

Patients enrolled to the trial will have a chest drain inserted and we will aim to drain to dryness and instill medical grade talc as described in the protocol

Procedure: ambulatory chest drain and talc pleurodesis

ambulatory chest drain and talc pleurodesis PROCEDURE

a chest drain will be inserted, fluid drained and medical talc instilled on an ambulatory basis

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Success rate of delivery of the ambulatory pleruodesis protocol

Time frame: 5 days

Can the investigators successfully deliver the described ambulatory pleruodesis protocol within the 5 day time frame and what is the success rate of the protocol delivery.

Secondary measures

Patient satisfaction / Patient related outcome measurement

Time frame: 5 days

Questionnaire on breathlessness and chest pain at day 5 and semi-structured interview on the patient experience of the intervention

Patient satisfaction / Patient related outcome measurement

Time frame: 30 days

Questionnaire on breathlessness and chest pain at day 30 and semi-structured interview of the patient experience of the intervention

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

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1 locations

North Tees and Hartlepool NHS foundation trustStockton-on-Tees, County Durham, United KingdomStatus unknown

Study team and timeline

Lead sponsor
David Rollins
Study start
Jan 10, 2024 Actual
Primary completion
Jan 1, 2025 Actual
Study completion
Feb 1, 2025 Actual
First posted
Nov 12, 2024 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026