Bile Duct Strictures, Bile Duct Strictures of Unknown Origin, Cholangiocarcinoma, Gallbladder Cancer and Extrahepatic Cholangiocarcinoma, Pancreatic Cancer
Conditions
Brief summary
The diagnosis of malignant biliary strictures remains a challenging aspect of biliary endoscopy. Molecular biological testing techniques based on bile have been reported to improve detection rates. However, whether the combination of bile-based omics studies and biliary brush cytology/biopsy can enhance diagnostic sensitivity has not yet been reported. This study aims to collect bile from patients with malignant biliary strictures, screen for molecular markers associated with biliary malignancies through multi-omics analysis, and subsequently validate these markers to establish a bile-based molecular diagnostic model.
Interventions
PROCEDUREEndoscopic retrograde cholangiopancreatography
Since patients with biliary strictures almost universally require endoscopic biliary interventions for both diagnostic and drainage purposes, bile aspiration can be readily obtained during these procedures, facilitating subsequent analyses. However, proteomic and metabolomic profiling of bile in malignant biliary strictures remains unreported to date. This study aims to evaluate the diagnostic value of combining bile proteomics/metabolomics with biliary brush cytology/biopsy for malignant biliary strictures, while also providing evidence for identifying potential biomarkers.
Sponsors
Eastern Hepatobiliary Surgery Hospital
Shanghai 6th People's Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Indeterminate biliary strictures * Aged 18-90 years * Underwent ERCP with biliary biopsy and/or brush cytology
Exclusion criteria
* Coagulation disorders * Pregnancy * Malignancies of other organs unrelated to biliary strictures * Declined participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic sensitivity | histologically or cytogically confirmed , or followed up for 6 months |
Secondary
| Measure | Time frame |
|---|---|
| accuracy | histologically or cytologically confirmed or followed up for 6 months |
| Specificity | histologically or cytologically confirmed or followed up for 6 months |
| Positive predictive value, | histologically or cytologically confirmed or followed up for 6 months |
| negative predictive value | histologically or cytologically confirmed or followed up for 6 months |
| AUC area (histologically or cytologically confirmed or followed up for 6 months) | up for 6 months |
Countries
China
Contacts
Primary ContactXiaobo Cai, MD
Outcome results
None listed