Malignant biliary stricture
Conditions
Interventions
Perform endoscopic radiofrequency ablation therapy for malignant biliary stricture patients requiring biliary duct drainage before biliary stent placement
Sponsors
Graduate School of Medicine, Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with biliary stricture due to malignant disease and requiring biliary duct drainage 2) Patients with malignancy diagnosed pathologically or radiologically / endoscopically 3) Patients who are surgically inoperable or are not surgically applied 4) Patients who are over 20 years of age at the time of consent acquisition 5) Patients who do not take anticoagulants, antiplatelet drugs or patients who can be discontinued before the study treatment 6) After receiving sufficient explanation for the participation of this study, patients who gained written consent by the patient's free will with sufficient understanding
Exclusion criteria
Exclusion criteria: 1) Patients with malignant biliary stricture due to lymph node metastasis 2) Patient with pacemaker or defibrillator inserted 3) Patients who are unlikely to have a prognosis for 1 month 4) Patients with performance status 2 or higher 5) Patients who can not control bleeding tendency (PTINR 1.5 or more, platelet number 50,000 or less). 6) Patients with duodenal stenosis, obstruction that may affect biliary excretion 7) Patients who are pregnant, have a possibility of pregnancy, are within 28 days after birth, or who are breastfeeding 8) Patients with history of upper gastrointestinal surgical resection 9) Patients who have impaired renal function and can not perform contrast CT 10) Patients in which a bile duct metal stent has already been placed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious adverse event incidence | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure completion rate Evaluation of malignant biliary stricture diameter and stenosis length in retrograde cholangiography (before and after treatment) Evaluation of cauterization range using Dynamic CT Biliary stent patent term Overall survival Adverse event incidence (post-bleeding rate, cholangitis incidence rate, pancreatitis incidence rate, fever incidence rate, abdominal pain incidence rate) | — |
Countries
Japan
Contacts
Public ContactHarutoshi Sugiyama
Graduate School of Medicine, Chiba University Department of Gastroenterology
Outcome results
None listed