The efficacy of Indwelling Pleural Catheter placement versus IPC placement PLUS sclerosant (talc) in patients with malignant pleural effusions managed exclusively as out-patients - IPC-PLUS Trial

orth Bristol NHS Trust0 个研究点目标入组 154 人开始时间: 2012年5月28日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•1.Symptomatic malignant pleural effusion, agreed at appropriate local / regional MDT to require IPC, defined as pleural fluid in the context of: a.Histocytologically proven pleural malignancy, OR b.Otherwise unexplained pleural effusion in the context of clinically proven cancer elsewhere, OR c.Radiologically proven pleural malignancy as diagnosed in normal clinical practice on thoracic CT in the absence of histocytological proof 2.Expected survival greater than 2 months 3.Written informed consent to trial participation.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 66

•1. Age < 18 years. 2. Females who are pregnant or lactating. 3. Patient unable to provide informed consent. 4. Previous attempts at pleurodesis on same side as effusion requiring management. 5. Previously documented adverse reaction to talc or lidocaine. 6. Community services unable to drain indwelling pleural catheter at least twice per week. 7. Evidence of extensive lung entrapment on CXR or CT, or significant fluid loculation on ultrasound scan, to a level which would normally be a contraindication to attempted talc pleurodesis or IPC insertion. 8. Other contraindication to indwelling pleural catheter insertion 9. Patient has no access to a telephone

发起方

orth Bristol NHS Trust