Table 1.

Inclusion and exclusion criteria

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.

CBD common bile duct, EUS endoscopic ultrasound, INR international normalized ratio