Feasibility of Ambulatory Talc. Pleurodesis

NCT06682936 | Recruiting

• 1 other identifier: IRAS:330188
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Effusion; Malignancy; Palliative Care

Keywords

malignant pleural effusion; malignancy; palliative care

Outcome Measures

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.

  5 days

Secondary Outcomes (2)

• Patient satisfaction / Patient related outcome measurement

  5 days

• Patient satisfaction / Patient related outcome measurement

  30 days

Study Arms (1)

outpatient drain and talc pleurodesis

EXPERIMENTAL

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

ambulatory chest drain and talc pleurodesis PROCEDURE

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

outpatient drain and talc pleurodesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• David Rollins: lead

Study Sites (1)

North Tees and Hartlepool NHS foundation trust

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

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant; Neoplasms

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Kevin Conroy, MBBS, FRCP

  University Hospital of North Tees

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Conroy, MBBS, FRCP

CONTACT

01642624615; kevin.conroy@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research governance manager - TVRA

Model Details: Feasibility of outpatient intervention

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: November 12, 2024
• Study Start: January 10, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)