Bile Duct StenosisNCT05905744
"eyeMax Insight" Cholangioscopy for Unexplained Bile Duct Stenosis
An observational study of Bile Duct Stenosis, run by Changhai Hospital.
Trial summary
When clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bile Duct Stenosis
- What is being tested?
- cholangioscopy
- How many people
- 157 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Jul 2024
- How long will I take part?
- 6 Months
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with common bile duct stricture whose cause cannot be found by routine imaging and other examination methods.
Who may be able to join
- Unexplained bile duct strictures (cannot be clearly diagnosed by CT, MRI or other imaging methods);
Who cannot join
- Patients with cardiac dysfunction, acute pancreatitis, active viral hepatitis;
- Patients with mental illness; ③ Previously underwent choledochoscopy examination; ④ Malignant biliary obstruction;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter Clinical Study on the Diagnostic Value of "eyeMax Insight" Cholangioscopy for Unexplained Bile Duct Stenosis
When clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. This study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ERCP.
Read the detailed description
When clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. This study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ERCP.
The etiology of biliary strictures is complex, including not only malignant tumors , but also factors such as stones, inflammatory strictures, congenital variations and so on. Currently, the main methods for diagnosing malignant biliary obstruction in clinical practice include clinical examinations, biochemical testing (such as serum CA19-9), imaging, and endoscopic retrograde cholangiopancreatography (ERCP). However, these methods have limitations, such as the limited specificity and sensitivity of CA19-9 and the indirect imaging of ERCP after contrast agent filling. Therefore, these methods are relatively difficult to distinguish the benign and malignant nature of biliary lesions. This study intends to analyze the diagnostic value of the biliary endoscopy system for these unexplained bile duct stenosis.
- Conditions
- Bile Duct Stenosis
- Being tested
- cholangioscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholangioscopyDiagnostic test
cholangioscopy examination and forceps biopsy, followed by brush biopsy from ERCP
| Study group | Role | What they receive |
|---|---|---|
| patients with unexplained bile duct stenosis | Patients with unexplained bile duct stenosis undergo cholangioscopy examination and ERCP Receives: Diagnostic Test: cholangioscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive rate of visual diagnosis of cholangioscopy for unexplained bile duct stenosis
The results are compared with pathological results of surgical specimens
Measured: 1 years
positive rate of cholangioscopy-guided forceps biopsy
The results are compared with pathological results of surgical specimens
Measured: 1 years
Secondary outcomes (2)
adverse event rate of each individual technique
record any adverse events related to the procedure
Measured: 1 years
the positive rate of biopsy
cholangioscopy-guided forceps biopsy, ERCP-guided brush biopsy
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct StenosisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 157 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University, Zhejiang University, The First Affiliated Hospital of Nanchang University, West China Hospital, LanZhou University, First Affiliated Hospital Xi'an Jiaotong University, Peking University Cancer Hospital & Institute, First Hospital of China Medical University, First Affiliated Hospital of Guangxi Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second Affiliated Hospital of Baotou Medical College, Shandong Province Third hospital
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Yunfeng Wang, Doctor, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905744
- Sponsor's protocol ID
- eyeMAX
- Status last verified
- Jun 2023
- First submitted
- 31 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Study on the Diagnostic Value of "eyeMax Insight" Cholangioscopy for Unexplained Bile Duct Stenosis
- ClinicalTrials.gov ID
- NCT05905744
- Acronym / sponsor ID
- eyeMAX
- Conditions
- Bile Duct Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University, Zhejiang University, The First Affiliated Hospital of Nanchang University, West China Hospital, LanZhou University, First Affiliated Hospital Xi'an Jiaotong University, Peking University Cancer Hospital & Institute, First Hospital of China Medical University, First Affiliated Hospital of Guangxi Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second Affiliated Hospital of Baotou Medical College, Shandong Province Third hospital
- Study start
- Jun 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 15 Jun 2023 (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.
When clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. This study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ERCP.
Detailed description
When clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. This study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ERCP.
The etiology of biliary strictures is complex, including not only malignant tumors , but also factors such as stones, inflammatory strictures, congenital variations and so on. Currently, the main methods for diagnosing malignant biliary obstruction in clinical practice include clinical examinations, biochemical testing (such as serum CA19-9), imaging, and endoscopic retrograde cholangiopancreatography (ERCP). However, these methods have limitations, such as the limited specificity and sensitivity of CA19-9 and the indirect imaging of ERCP after contrast agent filling. Therefore, these methods are relatively difficult to distinguish the benign and malignant nature of biliary lesions. This study intends to analyze the diagnostic value of the biliary endoscopy system for these unexplained bile duct stenosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with unexplained bile duct stenosis | – | Diagnostic Test: cholangioscopyPatients with unexplained bile duct stenosis undergo cholangioscopy examination and ERCP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with common bile duct stricture whose cause cannot be found by routine imaging and other examination methods.
Key inclusion criteria (1 listed)
- Unexplained bile duct strictures (cannot be clearly diagnosed by CT, MRI or other imaging methods);
Key exclusion criteria (2 listed)
- Patients with cardiac dysfunction, acute pancreatitis, active viral hepatitis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholangioscopycholangioscopy examination and forceps biopsy, followed by brush biopsy from ERCP | Diagnostic test | patients with unexplained bile duct stenosis |
Primary outcome
positive rate of visual diagnosis of cholangioscopy for unexplained bile duct stenosis
Time frame: 1 years
The results are compared with pathological results of surgical specimens
positive rate of cholangioscopy-guided forceps biopsy
Time frame: 1 years
The results are compared with pathological results of surgical specimens
2 secondary outcomes
adverse event rate of each individual technique
Time frame: 1 years
the positive rate of biopsy
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- 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. This study is not recruiting at the moment.
Yunfeng Wang, Doctor principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Stenosis, run by Changhai Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhendong Jin, Doctor (13901618837, Zhendjin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive rate of visual diagnosis of cholangioscopy for unexplained bile duct stenosis (time frame: 1 years). The study lists 2 primary outcomes in all. 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 15 Jun 2023.