Study on New Diagnostic Method for Biliary Stricture
Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)
Recruiting
Observational Study
Biliary StrictureBile Duct CancerPancreas Cancer
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 85
Sex
Any
Study type
Observational
Participants needed
99 (estimated)
Sponsor
Peking University Third Hospital · Other
Who this trial is looking for
This trial is looking for patients who may have uncertain biliary strictures and are eligible for a procedure called ERCP. Participants will help researchers test a new way to diagnose bile duct issues more effectively.
Are You a Good Fit for This Trial?
You may be able to join if
I have suspected biliary strictures
I am eligible for an ERCP procedure
You may not be able to join if
My ERCP failed or I cannot provide bile
I have severe health issues from other conditions
My expected overall survival is less than 1 year due to another disease
I may not follow the trial instructions or return for visits
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 malig…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients is suspected indetermined biliary strictures
* Patients have the indication for ERCP
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…
Inclusion Criteria:
* Patients is suspected indetermined biliary strictures
* Patients have the indication for ERCP
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
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