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Table 2 Selection criteria for WON walled-off necrosis. aDiagnosis of WON based on imaging procedures

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

Inclusion criteria:

Patients eligible for the trial must comply with all of the following at randomization

 • Age 18 years or older

 • Patient with indication (ASGE, Jacobson BC, GIE2005) of drainage of only one typea related to the symptomatology, as a local complication of previous acute pancreatitis

 • Patient capable of understanding and signing informed consent form

 • Patient understanding the type of study and complying with the follow-up of complementary tests during the study’s duration

Exclusion criteria

 • Pregnancy or breast-feeding

 • Severe coagulation disorder: INR > 1.5 not correctible with administration of plasma and/or platelets < 50,000/mm3

 • Asymptomatic patients, without clinical indication of drainage, except for those with vascular compression involvement

 • Non-identification of solid content during EUS procedure

 • Failure to sign informed consent form

 • Patients with intellectual handicap who are unable to understand the nature and possible consequences of the study, unless there is a competent legal representative

 • Patients unable to adhere to subsequent follow-up requirements

 • Conditions that preclude upper digestive endoscopy, such as stenosis

  1. Note: If there are several pancreatic collections, this does not exclude the patient from the trial. The patient is only excluded if there is more than one symptomatic collection to be drained
  2. EUS endoscopic ultrasound, INR international normalized ratio