A malignant distal biliary obstruction that is unresectable or presents a very high surgical risk
Conditions
Interventions
Transpapillary biliary drainage (ERCP)
Endoscopic ultrasound biliary drainage (EUS-BD)
Sponsors
Wakayama-Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years old or over 2) Radiological diagnosis (with or without pathological confirmation) of malignancy, and presence of a malignant distal biliary obstruction and dilation of the upstream bile duct that is unresectable or presents a very high surgical risk 3) Written consent obtained following adequate explanation of the study aims, design, and procedures.
Exclusion criteria
Exclusion criteria: 1) Radiological evidence of gastric outlet obstruction on CT, 2) Hilar biliary obstruction, 3) Surgically altered anatomy 4) ECOG performance status of 4, 5) Poorly controlled ascites, 6) History of endoscopic sphincterotomy (EST), 7) Biliary stenting, 8) Serious complication involving another organ, 9) Uncorrectable coagulopathy and/or thrombocytopenia, 10) Any other condition or situation determined by a study investigator to represent a reason for ineligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent patency rate at 180 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure success rate, clinical improvement rate, incident rate, procedure time, success rate of re-intervention, rate of successful stenting without dilatation (EUS-BD group only), survival time, and percentage of post-drainage chemotherapy | — |
Countries
Japan
Contacts
Public ContactMasahiro Itonaga
Wakayama-Medical University Second Department of Internal Medicine
Outcome results
None listed