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Table 3 Schedule of interventions and assessments in the WONDER-01 trial

From: WONDER-01: immediate necrosectomy vs. drainage-oriented step-up approach after endoscopic ultrasound-guided drainage of walled-off necrosis—study protocol for a multicentre randomised controlled trial

 

Study period

 

Pre-intervention

Intervention (within 6 months of randomisation)

Post-intervention

 

 ≤ 10 days before randomisation

 

Within 3 days of randomisation

7 days after intervention

Clinical success

After five years of clinical success

 

Screening

Randomisation

Intervention

 

Assessment

Follow-up

Informed consent

X

     

Eligibility screening

X

     

Assessment of WON

X

     

Assessment of symptoms

X

   

X

 

Body temperature

X

  

X

X

 

Blood testa

X

  

X

X

 

Imaging studyb

X

  

Xc

X

 

Electrocardiogram

X

     

Randomisation

 

X

    

Interventions

  

X

   

Assessment of primary endpoint

    

X

 

Assessment of secondary endpoints

   

X

X

X

Monitoring of adverse events

   

X

X

X

  1. aA blood test includes the following items: white blood cell count, haemoglobin, platelet count, albumin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, total bilirubin, amylase, lipase, blood urea nitrogen, creatinine, C-reactive protein, and international normalised ratio of prothrombin time
  2. bContrast-enhanced computed tomography is performed unless there are contraindications for contrast use. Magnetic resonance imaging may be performed on the investigator’s discretion
  3. cImaging studies are performed at least every 2–3 weeks during the intervention period
  4. Abbreviation: WON Walled-off necrosis