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Clinical Trials/ISRCTN73255764
ISRCTN73255764Completed未知

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

orth Bristol NHS Trust (UK)0 sites154 target enrollmentStarted: August 23, 2012Last updated:
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Conditions

Trial Snapshot

Phase
未知
Status
Completed
Sponsor
Enrollment
154
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25880969 protocol 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29617585 results

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Symptomatic malignant pleural effusion, agreed at appropriate local / regional MDT to require IPC, defined as pleural fluid in the context of:
  • •1.1. Histocytologically proven pleural malignancy, OR
  • •1.2. Otherwise unexplained pleural effusion in the context of clinically proven cancer elsewhere, OR
  • •1.3. 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.
  • •4. Male or female participants
  • •5. Lower Age Limit 18 years

Exclusion Criteria

  • •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

Investigators

Sponsor
orth Bristol NHS Trust (UK)

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