Malignant biliary obstruction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: atients who can be diagnosed as malignant biliary obstruction by imaging and pathology, and who are expected to have difficulty in trans-papillary drainage by ERCP for any of the following reasons, and who are eligible for EUS-BD and have obtained written consent 1) Gastrointestinal invasion is suspected on imaging, and it is difficult or expected to be difficult to reach the main papilla endoscopically. 2) Patients with postoperative reconstructed intestine, and difficulty in reaching the main papilla by lateral viewing duodenoscope is expected. 3) Unsuccessful drainage by ERCP
Exclusion criteria
Exclusion criteria: Less than 20 years old Intrahepatic bile duct diameter less than 3 mm EUS-BD puncture line cannot avoid metastatic liver tumor Large amount of ascites Poorly controlled infections Severe drug allergy. Pregnant or potentially pregnant and lactating women Severe mental disorder Patients who are judged by the principal investigator or sub-investigator to be unsuitable for the safe conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy between the target angle and the actual puncture angle during the initial bile duct puncture | — |
Secondary
| Measure | Time frame |
|---|---|
| technical sucsess, stenting success on first puncture, first puncture success within tolerance (2 degrees), number of punctures required, procedure time, clinical response rate, duration of stent function maintenance, incidents, overall survival (up to 1 year) | — |
Countries
Japan
Contacts
Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatology