ClinicalTrials.gg
CompletedNCT06682936Updated Nov 10, 2026

Feasibility of Ambulatory Talc. Pleurodesis

An interventional study of ambulatory chest drain and talc pleurodesis in Malignant Pleural Effusion, Malignancy and Palliative Care, sponsored by David Rollins. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by David Rollins · Not applicable, Interventional, and Other

Updated Nov 10, 2026Now CompletedEnrollment updated+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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 detailed 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)

02

Conditions studied

  • Malignant Pleural Effusion
  • Malignancy
  • Palliative Care

Keywords

  • malignant pleural effusion
  • malignancy
  • palliative care
03

In context

Pleural Effusion, Malignant

169 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.

This study's enrollment of 15 is below the median of 55 across 125 interventional studies indexed under Pleural Effusion, Malignant.

Browse Pleural Effusion, Malignant studies →

Lead sponsor

This is the only study on the registry with David Rollins as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous failed pleurodesis (on affected side)
  • Known non-expansile lung
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    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

Interventions

  • Procedureambulatory chest drain and talc pleurodesis

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

06

What researchers measure

Primary outcomes

  1. Success rate of delivery of the ambulatory pleruodesis protocol

    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.

    Time frame: 5 days

Secondary outcomes

  1. Patient satisfaction / Patient related outcome measurement

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

    Time frame: 5 days

  2. Patient satisfaction / Patient related outcome measurement

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

    Time frame: 30 days

07

Study locations

1 site
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — The primary end point of this trial is feasibility of intervention delivery. We will share our results and our protocol. All other outcomes are qualitative and will be reported at the end of the trial. Making individual participant data available to other researches does not seem necessary

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2024 to primary completion in Jan 2025, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2024
First posted
Nov 12, 2024
StartActual
Jan 10, 2024
Primary completionActual
Jan 1, 2025
CompletionActual
Feb 1, 2025
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 10, 2026
Sites
1 site added, 1 site removed
Show site
  • North Tees and Hartlepool NHS foundation trust · Stockton-on-Tees, United Kingdom
Show 1 removed
  • North Tees and Hartlepool NHS foundation trust · Stockton-on Tees, United Kingdom
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Recruiting→Completed
    1 site added, 1 site removed
    Show site
    • North Tees and Hartlepool NHS foundation trust · Stockton-on-Tees, United Kingdom
    Show 1 removed
    • North Tees and Hartlepool NHS foundation trust · Stockton-on Tees, United Kingdom
    + 3 other changes: verification date, date precision and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06682936
Lead sponsor
David Rollins
Responsible party
David Rollins (Research governance manager - TVRA, North Tees and Hartlepool NHS Foundation Trust) — Sponsor-investigator
First posted
Nov 12, 2024
Start date
Jan 10, 2024
Primary completion
Jan 1, 2025
Completion
Feb 1, 2025
Last update
Nov 10, 2026

Study contacts

Kevin Conroy, MBBS, FRCP
principal investigator · University Hospital of North Tees

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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