Malignant hilar biliary obstruction case
Conditions
Interventions
Inside plastic stent placement for malignant hilar bile duct obstruction
Sponsors
Other
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with unresectable malignant hilar biliary obstruction Patients with a pathological diagnosis of malignancy Patients requiring biliary drainage due to abnormal values in any of the following: serum total bilirubin, AST, ALT, ALP, or g-GTP The criteria for abnormal values are as follows Total bilirubin more than 2 mg/dL AST more than 45 IU/L ALT more than 45 IU/L ALP more than 170 IU/L g-GTP more than 75 IU/L Patients undergoing initial bilateral inside plastic stent placement Patients expected to have a prognosis of at least 2 months Patients with Bismuth type II-IV (requiring bilateral biliary drainage) Age more than 18 years
Exclusion criteria
Exclusion criteria: Patients with concomitant distal biliary obstruction Patients with surgically altered anatomy (excluding Billroth I reconstruction) Patients with severe comorbidities affecting other organs Patients in whom biliary cannulation (transpapillary approach) is not feasible Patients with concomitant duodenal obstruction ECOG performance status 4 Patients deemed unsuitable by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent patency duration and stent occlusion rates at 30, 60, and 90 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical and clinical success rates of stent placement Adverse events associated with stent placement Overall survival Details of reintervention at the time of stent occlusion Stent removal success rate Types of stents used during reintervention, and technical and clinical success rates of reintervention Stent patency duration after reintervention | — |
Countries
Japan
Contacts
Public ContactMitsuru Okuno
Matsunaimi general hospital Department of Gastroenterology
Outcome results
None listed