Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)

Recruiting now

Conditions studied: Biliary Stricture, Bile Duct Cancer, Pancreas Cancer

In brief

Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures. Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%. In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy.

Key facts

Study ID

NCT06277531

Run by

Peking University Third Hospital

People needed

99

Starts

2024-03-01

Expected to finish

2026-07-01

Last updated by the study team

2025-05-28

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients is suspected indetermined biliary strictures
• Patients have the indication for ERCP

You may not qualify if…

• ERCP failed, or can not obtain bile
• Sever comorbidities
• Predicted overall survival less than 1 year because of other disease
• Patients who are unlikely to comply with the protocol, inability to return for subsequent visits

Where it is running

• Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)
• Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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