Randomised controlled trial comparing outpatient management of malignant pleural effusion via an indwelling pleural catheter and talc pleurodesis versus standard inpatient management in improving health related quality of life

Guy's & St Thomas' NHS Foundation Trust0 个研究点目标入组 142 人开始时间: 2015年9月30日最近更新: 2023年12月4日

适应症

试验速览

•1. Age 18 years or over
•2. Diagnosis of malignant pleural effusion
•3. WHO performance status 2 or less unless performance status is impaired by presence of effusion and likely to significantly improve with drainage
•4. Expected survival greater than 3 months

•1. Aged less than 18 years old
•2. Pregnant or lactating
•3. Known allergy to Talc or Lignocaine
•4. Lack of symptomatic relief from effusion drainage
•5. At least twice weekly drainage cannot be undertaken
•6. Lymphoma or small cell carcinoma except*:
•6.1. Failure of chemotherapy
•6.2. Deemed for palliative management
•7. Non malignant effusions
•8. Loculated pleural effusion
•9. Unable to provide written informed consent to trial participation
•*Lymphoma and small cell carcinoma are particularly sensitive to treatment with chemotherapeutic agents. If patients have undergone chemotherapy with no treatment response or deemed not for chemotherapy and for palliative management then they will be suitable for inclusion in the study. Liason with the patient’s oncologist or MDT discussion will be required to ascertain this.

发起方

Guy's & St Thomas' NHS Foundation Trust