Feasibility of Ambulatory Talc. Pleurodesis

NCT ID: NCT06682936

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2025-02-28

Brief 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.

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)

Conditions

Malignant Pleural Effusion; Malignancy; Palliative Care

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ambulatory chest drain and talc pleurodesis

Intervention Type: PROCEDURE

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

Interventions

ambulatory chest drain and talc pleurodesis

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

David Rollins

OTHER

Sponsor Role: lead

Responsible Party

David Rollins

Research governance manager - TVRA

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kevin Conroy, MBBS, FRCP

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Tees

Locations

North Tees and Hartlepool NHS foundation trust

Stockton-on-Tees, County Durham, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Kevin Conroy, MBBS, FRCP

Role: CONTACT

kevin.conroy@nhs.net

01642624615

Facility Contacts

Kevin Conroy, MBBS, FRCP

Role: primary

kevin.conroy@nhs.net

01642624615

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IRAS:330188

Identifier Type: -

Identifier Source: org_study_id