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Table 1 Schedule of treatment for each visit and follow-up procedures

From: Australasian Malignant PLeural Effusion (AMPLE)-3 trial: study protocol for a multi-centre randomised study comparing indwelling pleural catheter (±talc pleurodesis) versus video-assisted thoracoscopic surgery for management of malignant pleural effusion

 

Study period

Pre-procedure

Post-procedure

Enrolment

Within 2/52

Days post-procedure

Months

Timepoint

T-1

T0

D1

Discharge

D7-10

D28

2–6

9

12

Enrolment:

 Clinical assessment

X

X

X

 

X

X

X

X

X

 Bedside ultrasounda

X

   

X

X

X

X

X

 Informed consent

X

        

  Baseline data collection

X

        

  Blood testsb

X

        

  CXRc

X

   

X

X

X

X

X

 Randomisation (IVRS)

X

        

Interventions:

 Drainage procedure (VATS or IPC)

 

X

       

Assessments:

 Questionnaires (VAS QoL, dyspnoea, pain; EQ5D5L)

X

   

X

   

X

 Logbook commencement

  

X

      

 Logbook collection

     

X

   

 Procedure-related data collection

   

X

     

 ActiGraph to participant—lead site only

  

X

  

X

X

  

 Assessment for pleurodesisd

    

X

X

X

X

X

 Assessment for re-intervention

  

X

 

X

X

X

X

X

 Adverse event review

  

X

 

X

X

X

X

X

  1. aBedside ultrasound mandatory at baseline only
  2. bBlood tests to include FBC, albumin, LDH, and CRP
  3. cCXR mandatory at baseline, days 7–10, and months 1, 3, 6, 9, and 12
  4. dIPC arm only. Spontaneous pleurodesis is defined as < 50 ml drain output on 3 consecutive drainages at least 24 h apart
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Trials

ISSN: 1745-6215