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CompletadoNCT06682936Registro de ClinicalTrials.gov

Feasibility of Ambulatory Talc. Pleurodesis

Malignant Pleural Effusion · Malignancy · Palliative Care

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
15 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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)

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No aplica
Enmascaramiento
Sin enmascaramiento
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

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Success rate of delivery of the ambulatory pleruodesis protocol

Plazo: 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.

Medidas secundarias

Patient satisfaction / Patient related outcome measurement

Plazo: 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

Plazo: 30 days

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

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

North Tees and Hartlepool NHS foundation trustStockton-on-Tees, County Durham, United KingdomEstado desconocido

Equipo y fechas

Patrocinador principal
David Rollins
Inicio del estudio
10 ene 2024 Real
Finalización primaria
1 ene 2025 Real
Finalización del estudio
1 feb 2025 Real
Primera publicación
12 nov 2024 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

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

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.

No incluyas expedientes médicos, diagnósticos, medicamentos, números de seguro ni otros datos sensibles. Este formulario es para preguntas generales, no para atención urgente.

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026