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

Recruiting

• Conditions: Biliary Stricture; Bile Duct Cancer; Pancreas Cancer

• Registration Number: NCT06277531
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-26
• Study Start: 2024-03-01
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29
• Primary Completion: 2026-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

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

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient is diagnosed with malignant disease from biliary system	in one year	Malignant tumor is confirmed by histopathology or cytopathology. If the pathology remains unclear, 2 gastroenterologists will finally confirm the diagnosis of the bile duct stricture after 1 year follow-up.

Trial Locations

Locations (2)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, China