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NCT Number: NCT06682936

Feasibility of Ambulatory Talc. Pleurodesis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Tees and Hartlepool NHS foundation trust

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

Location status: Recruiting

Location contact

Kevin Conroy, MBBS, FRCP

CONTACT

[email protected]

01642624615

About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ambulatory chest drain and talc pleurodesis

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Conroy, MBBS, FRCP

CONTACT

[email protected]

01642624615

Sponsors and collaborators

Lead sponsor

David Rollins

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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