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Table 4 Data management, calendar

From: Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis – PROMETHEUS: a randomized controlled trial protocol

Timepoint/stages

Study Period

Baseline

Intervention

24 h

7 days ±

4 weeks ± 3 days

8 weeks ± 5 days (Telephone)

16 weeks (4 months) ± 10 days

6 months ± 10 days (Telephone)

8 months ± 10 days

12 months ± 10 days (Telephone)

Enrollment

 Informed consent

X

         

 Clinical history and exploration

X

         

 Eligibility screen

X

         

 Allocation

X

         

Intervention

 Implantation

 

X

        

 Removal

    

X

     

 INR

 

X

        

Assessments:

 Blood test

X

 

X

 

X

 

X

 

X

 

 Imaging test

X

X

  

X

Xa

X

 

X

 

 Symptomatology

X

 

X

X

X

X

X

X

X

X

 Visit

  

X

 

X

 

X

 

X

 

 Telephone contact

   

X

 

X

 

X

 

X

 Adverse effects

X

X

X

X

X

X

X

X

X

X

 Primary outcome

    

X

     

 Secondary outcomes

    

X

     

 Medication

X

X

X

X

X

X

X

X

X

X

  1. aOnly in case of radiological clinical success but with persistence of the collection > 5 cm