Biliary Strictures Biliary Strictures, cholangiocarcinoma
Conditions
Interventions
This study is a multicenter, prospective interventional study (randomized controlled trial) with a crossover design. In each enrolled patient, brush cytology will be performed using both the novel bru
biliary brush cytology, ERCP, biliary stricture, brush catheter
Sponsors
Inoue Tadahisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals with biliary stricture identified on imaging findings such as CT, MRI, or ultrasonography. 2. Individuals judged to require pathological diagnosis for the differential diagnosis of cholangiocarcinoma. 3. Individuals aged 18 years or older at the time of informed consent, regardless of sex. 4. Individuals from whom written informed consent has been voluntarily obtained from the participants themselves after they have received a sufficient explanation of the study and have adequately understood its contents.
Exclusion criteria
Exclusion criteria: 1. Patients with an already established pathological diagnosis of the target biliary stricture lesion. 2. Patients in whom pancreatic cancer is suspected based on imaging findings. 3. Patients in whom extrinsic biliary stricture due to compression by lymph nodes or other lesions is suspected based on imaging findings. 4. Patients in whom biliary access by ERCP is impossible or considered difficult. 5. Patients with surgically altered anatomy. 6. Patients judged unable to safely undergo endoscopic examination. 7. Patients who are pregnant or may be pregnant. 8. Patients considered inappropriate for participation in this study by the principal investigator or a subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity | — |
Secondary
| Measure | Time frame |
|---|---|
| Adequate specimen collection rate Specificity Accuracy Adverse event rate Cellularity | — |
Contacts
Public ContactTadahisa Inoue
Aichi Medical University
Outcome results
None listed