malignant distal biliary obstruction
Conditions
Interventions
Currently, endoscopic retrograde cholangiopancreatography (ERCP)-guided transpapillary placement of a metal stent (MS) is the first-line treatment for biliary drainage in patients with unresectable ma
Sponsors
Inoue Tadahisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with malignant distal biliary stricture based on histological/cytological findings or imaging studies. 2. Patients with unresectable disease (including those deemed unresectable due to either patient- or tumor-related factors, as well as those who refuse surgical resection). 3. Patients with abnormal levels of total serum bilirubin, AST, ALT, GTP, or ALP who require endoscopic biliary drainage. 4. Patients aged 18 years or older at the time of obtaining consent, regardless of sex. 5. Patients who have received a full explanation regarding this study and have provided written informed consent of their own free will after sufficient understanding.
Exclusion criteria
Exclusion criteria: 1. Patients in whom the upper margin of the stricture is located within 3 cm of the confluence of the right and left hepatic ducts. 2. Patients who have already undergone any form of biliary drainage. 3. Patients with a prior history of endoscopic papillary intervention or biliary stent placement. 4. Patients with surgically altered anatomy. 5. Patients with gastric or duodenal obstruction confirmed by imaging studies. 6. Patients with massive ascites. 7. Patients whose life expectancy is less than 3 months. 8. Patients who are judged to be unable to safely undergo endoscopic procedures. 9. Pregnant women or those who may be pregnant. 10. Patients deemed inappropriate for inclusion in this study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month recurrent biliary obstruction (RBO)-free Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to RBO 2. Overall survival 3. Adverse event-free survival 4. Incidence of RBO (RBO rate) 5. Causes of RBO 6. Technical success rate 7. Clinical success rate 8 Procedure time 9. Incidence and types of adverse events other than RBO 10. Technical success rate and procedural details of reintervention for RBO 11. Success rate of stent removal at reintervention for RBO 12. Clinical success rate of reintervention for RBO 13. Procedure time for reintervention for RBO 14. Incidence and types of adverse events associated with reintervention for RBO 15. Time to RBO after reintervention for RBO 16. Total number of reinterventions for RBO and total number of RBO episodes | — |
Contacts
Public ContactTadahisa Inoue
Aichi Medical University
Outcome results
None listed