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Table 2 Eligibility criteria for 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

Inclusion criteria

Exclusion criteria

Patients with WON defined by the revised Atlanta classification [2]

WON inaccessible via the EUS-guided approach

The longest diameter of WON is 4 cm or larger

A LAMS in situ

Patients requiring drainage for WON

Coagulopathy (platelet count < 50,000/mm3 or PT-INR > 1.5)

Patients with symptoms due to WON (e.g. infection, GI symptoms, or jaundice)

Antithrombotic agents cannot be discontinued according to the JGES guideline [29]

Patients aged 18 years or older

Patients who do not tolerate endoscopic procedures

Patients or their representatives provide informed consent

Pregnant women

 

Patients considered inappropriate for inclusion by the investigators

  1. Abbreviations: EUS Endoscopic ultrasound, JGES Japan Gastroenterological Endoscopy Society, LAMS Lumen-apposing metal stent, PT-INR, Prothrombin time international normalised ratio, WON Walled-off necrosis