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Table 1 Inclusion and exclusion criteria

From: Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction—BAMPI TRIAL: an open-label, randomized controlled trial protocol

Inclusion criteria:
Patients eligible for the trial must fulfill all the following at randomization
- Age 18 years or more.
- Malignant biliary obstruction with clinical criteria that justifies EUS-guided biliary drainage.
- Capable of understanding and signing informed consent form.
- Understanding the type of study and complying with the follow-up of complementary tests during the study’s duration.
Exclusion criteria:
Patients with any of the following will be excluded
- Pregnancy or breast-feeding.
- Severe coagulation disorder: INR > 1.5 not correctible with administration of plasma and/or platelets < 50,000/mm3.
- Maximum cross diameter of the CBD < 10 mm.
- Another type of biliary drainage at the time of the procedure (cholecystostomy, percutaneous drainage, etc.).
- Failure to sign informed consent form.
- Intellectual handicap and unable to understand the nature and possible consequences of the study, unless there is a competent legal representative.
- Unable to adhere to subsequent follow-up requirements.
  1. CBD common bile duct, EUS endoscopic ultrasound, INR international normalized ratio