Pancreaticobiliary MaljunctionNCT06903520
Clinical Correlation Study Between Anomalous Pancreaticobiliary Ductal Junction and Malignant Tumors of the Biliary System and the Establishment of an AI-based Automated Recognition System
An observational study of Pancreaticobiliary Maljunction, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To explore the occurrence of pancreaticobiliary maljunction (PBM) in the Chinese population, the characteristics of various subtypes, and the relationship between PBM and malignant tumors of the biliary system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreaticobiliary Maljunction
- How many people
- 2,439 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: patients with pancreaticobiliary maljunction
Who may be able to join
- Cases that were hospitalized and underwent Magnetic resonance cholangiopancreatography (MRCP) examination at the First Medical Center of Chinese People's Liberation Army General Hospital.
Who cannot join
- Patients aged less than 18 years old;
- Those with unclear diagnosis;
- Cases with missing or poor-quality imaging data.
Trial locations and contacts
1 site in 1 country.
About this study
To explore the occurrence of pancreaticobiliary maljunction (PBM) in the Chinese population, the characteristics of various subtypes, and the relationship between PBM and malignant tumors of the biliary system. To explore the general clinical characteristics of patients with mild bile duct dilation but who have not been clinically diagnosed with choledochal cysts, as well as the relationship between these characteristics and malignant tumors of the biliary system. To develop and evaluate a deep learning method for machine learning of Magnetic resonance cholangiopancreatography (MRCP) images, enabling fully automated detection of pancreaticobiliary maljunction.
- Conditions
- Pancreaticobiliary Maljunction
- Medical subject headings
- Pancreaticobiliary Maljunction
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of malignant tumors of the biliary system
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Apr 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreaticobiliary MaljunctionStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 2,439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Wenping, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903520
- Sponsor's protocol ID
- 2023-037-01
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Correlation Study Between Anomalous Pancreaticobiliary Ductal Junction and Malignant Tumors of the Biliary System and the Establishment of an AI-based Automated Recognition System
- ClinicalTrials.gov ID
- NCT06903520
- Acronym / sponsor ID
- 2023-037-01
- Conditions
- Pancreaticobiliary Maljunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,439 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 30 Mar 2025 (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.
To explore the occurrence of pancreaticobiliary maljunction (PBM) in the Chinese population, the characteristics of various subtypes, and the relationship between PBM and malignant tumors of the biliary system. To explore the general clinical characteristics of patients with mild bile duct dilation but who have not been clinically diagnosed with choledochal cysts, as well as the relationship between these characteristics and malignant tumors of the biliary system. To develop and evaluate a deep learning method for machine learning of Magnetic resonance cholangiopancreatography (MRCP) images, enabling fully automated detection of pancreaticobiliary maljunction.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with pancreaticobiliary maljunction
Key inclusion criteria (1 listed)
- Cases that were hospitalized and underwent Magnetic resonance cholangiopancreatography (MRCP) examination at the First Medical Center of Chinese People's Liberation Army General Hospital.
Key exclusion criteria (3 listed)
- Patients aged less than 18 years old;
- Those with unclear diagnosis;
- Cases with missing or poor-quality imaging data.
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
The incidence rate of malignant tumors of the biliary system
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreaticobiliary Maljunction, run by Chinese PLA General Hospital at 1 site 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of malignant tumors of the biliary system (time frame: 1 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 30 Mar 2025.