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Bile lipidomics-based investigation of lipid alterations and their clinical significance in patients with cholangiocarcinoma

Bile lipidomics-based investigation of lipid alterations and their clinical significance in patients with cholangiocarcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127872
Enrollment
Unknown
Registered
2026-07-09
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

Interventions

Index test:The effectiveness of lipid biomarkers in bile for diagnosing cholangiocarcinoma and benign bile duct diseases based on bile lipidomics analysis.

Sponsors

The second hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Benign bile duct disease group: (1) Patients confirmed by imaging and/or postoperative pathology to have benign bile duct diseases (further divided into inflammatory bile duct diseases, including recurrent suppurative cholangitis, primary biliary cholangitis, primary sclerosing cholangitis, etc., and non-inflammatory diseases); (2) Patients whose age and sex match those in the malignant bile duct disease group; (3) Patients planning to undergo ERCP treatment; (4) Patients who voluntarily participate in the study and sign the informed consent form. 2. Malignant bile duct tumor group: (1) Patients confirmed by cytology or histopathology to have malignant bile duct tumors; (2) Patients with definite clinical or pathological staging according to the TNM staging system; (3) Patients planning to undergo ERCP treatment; (4) Patients who voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Benign Bile Duct Disease Group: (1) Pathologically confirmed as malignant or high-grade dysplasia before or after surgery; (2) Imaging suggests possible malignancy; (3) Presence of malignant tumors in other organs; (4) Pregnant or breastfeeding women; (5) Sepsis caused by bile duct infection; (6) People prone to bleeding or with coagulation disorders; (7) Other situations that the researchers judge as unsuitable for participating in this study. 2. Bile Duct Malignant Tumor Group: (1) Pathological type is not cholangiocarcinoma; (2) Has other malignant tumors (e.g., pancreatic cancer); (3) Metastatic cancer; (4) Have received any known anticancer treatment; (5) Sepsis caused by bile duct infection; (6) Diagnosis is unclear due to lack of clinical information or insufficient follow-up time; (7) Pregnant or breastfeeding women; (8) People prone to bleeding or with coagulation disorders.

Design outcomes

Primary

MeasureTime frame
Sensitivity ;accuracy;

Countries

China

Contacts

Public ContactZhang Rixin

The second hospital of Dalian Medical University

zrx20400218@163.com+86 10 1234 5678

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026