unresectable distal biliary malignancies
Conditions
Interventions
Covered biliary metallic stent with a 10-mm diameter
Covered biliary metallic stent with a 12-mm diameter
Sponsors
BORE Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 1) with unresectable malignant distal biliary obstruction (> 2 cm distal to the biliary hilum) 2) expected prognosis more than 2 months 3) 20 years old 4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) < grade 2 5) obtained written informed consent.
Exclusion criteria
Exclusion criteria: 1) patients with massive ascites 2) patients with severe comorbidities in other organs 3) prior biliary SEMS placement 4) patients with surgically altered anatomy 5) difficulty to achieve biliary cannulation during endoscopic retrograde cholangiography 6) intestinal obstruction distal to the ampulla 7) patients with pregnancy 8) patients considered ineligible by attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent occlusion rate and dysfunction rate at 180 days after stent deployment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Stent patency duration 2) Time to recurrent biliary obstruction (TRBO) 3) Overall stent patency rate and function rate 4) Median survival time 5) Stent-related complication rate | — |
Countries
Japan
Contacts
Public ContactMukai Tsuyoshi
Gifu Municipal Hospital Department of Gastroenterology
Outcome results
None listed