Malignant Biliary Strictures
Conditions
Interventions
Intervention group:The stenotic segments were dilated using paclitaxel-coated balloons. After dilation, biliary stents (metal stents or plastic stents) were implanted according to clinical needs and c
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, both genders. 2. Confirmed by imaging and pathology as unresectable malignant biliary stricture (including hilar cholangiocarcinoma, distal cholangiocarcinoma, pancreatic cancer invasion, etc.). 3. Stricture length =3 months. 6. Voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Coagulation dysfunction (INR >1.5, platelet count <50×10^9/L) that cannot be corrected. 2. Known allergy to paclitaxel, contrast media, or balloon materials. 3. Multiple diffuse intrahepatic strictures or complete bile duct occlusion that prevents guidewire passage. 4. Complicated with severe acute cholangitis (uncontrolled septic shock). 5. Pregnant or breastfeeding women. 6. Complicated with other active malignancies. 7. Participation in other drug or device clinical trials within 3 months before enrollment. 8. Other conditions deemed unsuitable for enrollment by the investigator (e.g., severe cardiopulmonary insufficiency, inability to tolerate ERCP procedure, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biliary patency rate at 6 months after procedure;Punching rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of cholangitis;Technical success rate;Incidence rate of postoperative pancreatitis;Stent patency time;Reintervention rate;Life quality score;Rebleeding rate; | — |
Countries
China
Contacts
Public ContactWang Lei
Nanjing Drum Tower Hospital
Outcome results
None listed