Biliary StrictureECCBILENCT06277531
Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)
An observational study of Biliary Stricture and Bile Duct Cancer, run by Peking University Third Hospital at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Biliary Stricture, Bile Duct Cancer, Pancreas Cancer
- How many people
- 99 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2024to 1 Jul 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are suspected indetermined biliary strictures
Who may be able to join
- Patients is suspected indetermined biliary strictures
- Patients have the indication for ERCP
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 1000191
Zhuo Cheng, M.D., +86-18701012781, chengzhuo321@pku.edu.cn
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Xiue Yan, M.D., +86-15811117418, pskyq@163.com
About this study
Official title: Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE): a Prospective Cohort Study
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.
- Conditions
- Biliary Stricture, Bile Duct Cancer, Pancreas Cancer
- Keywords
- Malignant Biliary Stricture, Cell-Free Extrachromosomal Circular DNA (eccDNA), Liquid-Biopsies Assay
- Medical subject headings
- Bile Duct Neoplasms, Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient is diagnosed with malignant disease from biliary system
Malignant tumor is confirmed by histopathology or cytopathology. If the pathology is unclear or inaccessible, 2 gastroenterologists will finally confirm the diagnosis of the bile duct stricture after 1 year follow-up.
Measured: in one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tsinghua Changgeng Hospital
- Responsible party
- Sponsor
- Investigators
- Yonghui Huang, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277531
- Sponsor's protocol ID
- IRB00006761-M2024086
- Acronym
- ECCBILE
- Status last verified
- May 2025
- First submitted
- 19 Feb 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE): a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06277531
- Acronym / sponsor ID
- ECCBILE / IRB00006761-M2024086
- Conditions
- Biliary Stricture, Bile Duct Cancer, Pancreas Cancer
- Keywords
- Malignant Biliary Stricture, Cell-Free Extrachromosomal Circular DNA (eccDNA), Liquid-Biopsies Assay
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Tsinghua Changgeng Hospital
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are suspected indetermined biliary strictures
Key inclusion criteria (2 listed)
- Patients is suspected indetermined biliary strictures
- Patients have the indication for ERCP
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient is diagnosed with malignant disease from biliary system
Time frame: in one year
Malignant tumor is confirmed by histopathology or cytopathology. If the pathology is unclear or inaccessible, 2 gastroenterologists will finally confirm the diagnosis of the bile duct stricture after 1 year follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yonghui Huang principal investigator
Peking University Third Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Stricture and Bile Duct Cancer, run by Peking University Third Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yonghui Huang, M.D (+86-13911765322, 13911765322@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient is diagnosed with malignant disease from biliary system (time frame: in one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.