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NCT Number: NCT07007832

Bile Omics for Diagnosing Indeterminate Biliary Strictures

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.

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Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Bile Duct Strictures Bile Duct Strictures of Unknown Origin Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gallbladder Cancer and Extrahepatic Cholangiocarcinoma Gallbladder Diseases Gallbladder Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200080

Location status: Recruiting

Location contact

Xingdong Zheng, PhD

CONTACT

[email protected]

86-021-63240090

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic retrograde cholangiopancreatography

Procedure

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.

Other names: biliary brush cytology, biopsy

Primary outcomes

  1. Diagnostic sensitivity

    Time frame: histologically or cytogically confirmed , or followed up for 6 months

Secondary outcomes

  1. accuracy

    Time frame: histologically or cytologically confirmed or followed up for 6 months

  2. Specificity

    Time frame: histologically or cytologically confirmed or followed up for 6 months

  3. Positive predictive value,

    Time frame: histologically or cytologically confirmed or followed up for 6 months

  4. negative predictive value

    Time frame: histologically or cytologically confirmed or followed up for 6 months

  5. AUC area (histologically or cytologically confirmed or followed up for 6 months)

    Time frame: up for 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaobo Cai, MD

CONTACT

[email protected]

86+13918177123

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Eastern Hepatobiliary Surgery Hospital
  • Shanghai 6th People's Hospital

Registry information

Official study title

The Diagnostic Value of Bile-based Omics Analysis for Indeterminate Biliary Strictures

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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