Obstruction of biliary tract
Conditions
Interventions
Experimental group:Single use can carry particle drainage catheter drainage + radioactive particle brachytherapy
Control group:Simple biliary drainage catheter drainage
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)The age ranges from 18 to 80 years old and the gender of the patients is not limited, and; 2)Patients with biliary obstruction due to malignant tumors that is pathologically or cytologically diagnosed and is unresectable or unsuitable for surgery, or refuse external radiotherapy or surgery and require percutaneous hepatic aspiration; 3)Patients with hilar or extrahepatic bile duct obstruction 4)patients with measurable tumor size and cross-sectional CT imaging, the maximum transverse diameter of the tumor causing biliary obstruction was =3cm 5)ECOG 0-3; 6)Patients agree to participate in the study and voluntarily sign the informed consent;
Exclusion criteria
Exclusion criteria: 1)Portal vein main tumor cancer thrombus 2)Patients with severe bleeding tendency, platelet =30×109/L or severe coagulation disorder (prothrombin time > 21s) 3)Patients who had received anticoagulant or antiplatelet drug therapy within 7 days before surgery 4)Patients who had received biliary tract local radiotherapy within 3 months 5)Patients who are allergy to iodine-containing contrast media or polyurethane materials; 6)Patients who are systemic multiple organ failure; 7)Patients with a large amount of ascites and affected by puncture catheterization; 8)Patients with severe renal function or cardiopulmonary insufficiency; 9)Patients with diseases that may cause difficulties in treatment and evaluation (such as systemic infectious diseases, immune dysfunction, systemic conditions that cannot tolerate surgery, etc.); 10)Patients with life expectancy < 3 months; 11)Pregnant or lactating women; 12)Patients who are participating in clinical trials of other drugs or medical devices; 13)Other patients deemed unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success rate;Clinical success rate;Tumor control; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total bilirubin changes;Time of operation;Stent re-obstruction time;Overall Survival;Instrument performance evaluation; | — |
Countries
China
Contacts
Public ContactXinwei Han
First Affiliated Hospital of Zhengzhou University
Outcome results
None listed