Eus-giuded Biliary Drainage With Ec-lams vs ERCP as a Primary Intervention for Endoscopic Treatment of Patinets With Distal Malignant Biliary Obstruction
Keywords
Abstract
Dates
Last Verified: | 10/31/2019 |
First Submitted: | 09/18/2019 |
Estimated Enrollment Submitted: | 09/19/2019 |
First Posted: | 09/22/2019 |
Last Update Submitted: | 11/07/2019 |
Last Update Posted: | 11/11/2019 |
Actual Study Start Date: | 10/27/2019 |
Estimated Primary Completion Date: | 03/30/2020 |
Estimated Study Completion Date: | 03/30/2020 |
Condition or disease
Intervention/treatment
Procedure: ERCP
Procedure: EUS-BD
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
ERCP Endoscopic retrograde cholangiopancreatography (ERCP) | Procedure: ERCP Endoscopic retrograde cholangiopancreatography (ERCP) |
EUS-BD Endoscopic UltraSound Biliary Drainage | Procedure: EUS-BD Endoscopic UltraSound Biliary Drainage |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Sampling method | Non-Probability Sample |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - Age ≥18 years - Patients with distal malignant biliary obstruction - Abdominal ultrasound or computed tomography or magnetic resonance or EUS showing a dilated common bile duct > 15 mm diameter. - Agree to receive follow up phone calls - Able to provide written informed consent Exclusion Criteria: - Coagulation and/or platelets hereditary disorders and/or INR>1.5, PLT<50,000. - Use of anticoagulants that cannot be discontinued - Pregnant women - Inability to sign the informed consent |
Outcome
Primary Outcome Measures
1. Rate of post-procedural acute pancreatitis [6 months]