An observational study in Cholangiocarcinoma, Gallbladder Cancer and Extrahepatic Cholangiocarcinoma and Pancreatic Cancer, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Observational
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.
824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.
This study's planned enrollment of 260 is above the median of 196 across 161 observational studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 182 studies on the registry; 108 are open to participants now.
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Patients hospitalized in top-tier academic medical center in Shanghai, China (Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; The Third Affiliated Hospital of Naval Medical University; Shanghai Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pathologically or clinical confirmed
Procedure: Endoscopic 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.
Also known as: biliary brush cytology, biopsy
Diagnostic sensitivity
Time frame: histologically or cytogically confirmed , or followed up for 6 months
accuracy
Time frame: histologically or cytologically confirmed or followed up for 6 months
Specificity
Time frame: histologically or cytologically confirmed or followed up for 6 months
Positive predictive value,
Time frame: histologically or cytologically confirmed or followed up for 6 months
negative predictive value
Time frame: histologically or cytologically confirmed or followed up for 6 months
AUC area (histologically or cytologically confirmed or followed up for 6 months)
Time frame: up for 6 months
Plan to share: Undecided — We plan to share de-identified IPD upon reasonable request after publication, contingent on approval from our institutional ethics committee. Data availability will be subject to a formal data use agreement to ensure patient confidentiality and compliance with local regulations. Restrictions may apply to protect participant privacy given the sensitive nature of clinical biliary data.
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine →