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.