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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06277531
Other study ID # IRB00006761-M2024086
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date March 1, 2027

Study information

Verified date January 2024
Source Peking University Third Hospital
Contact Yonghui Huang, M.D
Phone +86-13911765322
Email 13911765322@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 99
Est. completion date March 1, 2027
Est. primary completion date March 1, 2026
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Patients is suspected indetermined biliary strictures - Patients have the indication for brush cytology during ERCP Exclusion Criteria: - ERCP or brush cytology 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

Study Design


Locations

Country Name City State
China Beijing Tsinghua Changgung Hospital Beijing Beijing
China Peking University Third Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Peking University Third Hospital Beijing Tsinghua Changgeng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient is diagnosed with malignant disease from biliary system 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. in one year
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