Biliary stricture
Conditions
Interventions
22G, 0.018-inch guidewire
Sponsors
Osaka Medical and Pharmaceutical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with biliary stricture in whom Endoscopic Retrograde Cholangiopancreatography is difficult or unsuccessful Age >18 years and <99 years at the time of enrollment Written informed consent obtained from the patient prior to participation in the study
Exclusion criteria
Exclusion criteria: Exclusion criteria: Patients with severe bleeding tendency or pregnancy Patients who have already undergone alternative biliary drainage procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Technical success rate Definition: Technical success is defined as successful placement of a stent in the target bile duct using a 22-gauge needle and the J-Wire NM (0.018-inch guidewire) during EUS-guided hepaticogastrostomy. No restriction is imposed on the type of stent used. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Adverse events: incidence and types Adverse events will be evaluated in accordance with the criteria of the American Society for Gastrointestinal Endoscopy. The definitions of anticipated adverse events are as follows: Bleeding: Presence of overt bleeding such as hematemesis or melena, or a decrease in hemoglobin level of >2g/dL on the day following the procedure. Perforation: Perforation associated with the endoscopic procedure. b) Procedure time Procedure time is defined as the interval from bile duct puncture to completion of stent placement. c) Use of dilation devices and their types Dilation is not routinely performed. However, dilation is permitted when insertion of the stent delivery system is not feasible. No restriction is imposed on the type of dilation device used. | — |
Countries
Japan
Contacts
Public ContactTakeshi Ogura
Osaka Medical and Pharmaceutical University Hospital Pancreatobiliary Advanced Medical Center
Outcome results
None listed