Malignant hilar biliary stricture cases Malignant hilar biliary stricture
Conditions
Interventions
Sponsors
Eligibility
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 > 2 mg/dL AST > 45 IU/L ALT > 45 IU/L ALP > 450 IU/L g-GTP > 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 > 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
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 | — |
Contacts
Matsunami General Hospital