CholedocholithiasisNCT07906782
Detection of Residual Bile Duct Stones by Cholangioscopy After Negative ERCP Cholangiography and Interobserver Agreement: A Self-Controlled Study
A study testing Peroral Cholangioscopy in people with Choledocholithiasis, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Common bile duct stones (CBDS) are a common biliary disorder, and endoscopic retrograde cholangiopancreatography (ERCP) is currently the primary minimally invasive approach for their diagnosis and treatment. Complete duct clearance is generally assessed by cholangiography after stone extraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- Peroral Cholangioscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2025to 15 Jan 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Patients with suspected common bile duct stones based on magnetic resonance cholangiopancreatography (MRCP), computed tomography (CT), or endoscopic ultrasonography (EUS)
Who cannot join
- Pregnancy
- Refusal of written informed consent
- Contraindications to ERCP exist
- Complicated with acute pancreatitis or acute cholangitis
- Coagulation dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Common bile duct stones (CBDS) are a common biliary disorder, and endoscopic retrograde cholangiopancreatography (ERCP) is currently the primary minimally invasive approach for their diagnosis and treatment. Complete duct clearance is generally assessed by cholangiography after stone extraction. However, conventional cholangiography may fail to detect residual stones because of air-bubble artifacts, small stone size, biliary sludge, mucosal folds, or impacted stones. Previous studies have demonstrated that occult residual stones may still be identified by direct cholangioscopy even after cholangiography indicates complete duct clearance, highlighting the limitations of conventional cholangiography. Residual stones may increase the risk of post-procedural cholangitis, recurrent biliary symptoms, recurrent CBDS, and the need for repeat ERCP.
Cholangioscopy enables direct visualization of the bile duct lumen and may facilitate the detection of small stones, stone fragments, and impacted stones that are difficult to identify by cholangiography. However, prospective evidence regarding the incremental diagnostic yield of cholangioscopy after negative ERCP cholangiography remains limited. Moreover, visual interpretation during cholangioscopy may be influenced by operator experience, and evidence regarding interobserver and intraobserver agreement remains insufficient. Therefore, this prospective study aims to evaluate the additional diagnostic value of cholangioscopy for detecting stones missed by ERCP cholangiography and to assess the reproducibility of cholangioscopic visual interpretation. The findings may provide clinical evidence for optimizing the assessment of complete bile duct clearance, standardizing the use of cholangioscopy, and reducing adverse outcomes associated with residual bile duct stones.
Read the detailed description
This prospective study will enroll patients with confirmed or suspected common bile duct stones who undergo endoscopic retrograde cholangiopancreatography (ERCP). Conventional cholangiography will be performed during ERCP to assess the presence of common bile duct stones. Patients with negative cholangiographic findings at the initial examination, as well as patients who undergo stone extraction and subsequently have negative cholangiographic findings indicating apparent duct clearance, will undergo additional cholangioscopic examination.
Cholangioscopy will be performed after negative ERCP cholangiography to directly inspect the bile duct lumen for occult or residual stones that may not be identified by conventional cholangiography. Particular attention will be paid to small stones, biliary sludge or stone fragments, and impacted stones. Findings from ERCP cholangiography and subsequent cholangioscopy will be systematically recorded, and the incremental diagnostic yield of cholangioscopy for detecting stones after negative cholangiographic findings will be evaluated.
In addition, recorded ERCP cholangiography videos and direct cholangioscopy videos will be independently reviewed by three experienced senior endoscopists. Each reviewer will assess whether common bile duct stones are present or absent based on the imaging modality being evaluated. To assess the reproducibility of visual interpretation, each reviewer will perform three separate rounds of evaluation, with a 2-week interval between consecutive rounds. The order of video presentation should be randomized for each round, and reviewers should be blinded to the original procedural findings, the assessments of the other reviewers, and their own previous assessments whenever feasible.
Interobserver agreement among the three reviewers and intraobserver agreement across the three assessment rounds will be analyzed separately for ERCP cholangiography and cholangioscopic visualization.
- Conditions
- Choledocholithiasis
- Being tested
- Peroral Cholangioscopy
- Keywords
- peroral cholangioscopy, ERCP, Choledocholithiasis
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroral CholangioscopyProcedure or surgery
Following negative ERCP cholangiography, either during the initial examination or after stone extraction, patients will undergo additional cholangioscopy to directly visualize the bile duct lumen and identify occult or residual common bile duct stones that may have been missed by conventional cholangiography. Cholangioscopic findings will be recorded for subsequent diagnostic evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Cholangioscopy Following Negative ERCP Cholangiography | Experimental | This study employs a self-controlled design. Patients with negative findings on initial ERCP cholangiography or negative cholangiographic findings following stone extraction will be enrolled and undergo subsequent cholangioscopy to detect occult or residual common bile duct stones. Receives: Procedure: Peroral Cholangioscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or Absence of Occult or Residual Common Bile Duct Stones
Presence or Absence of Occult or Residual Common Bile Duct Stones
Measured: Immediately after cholangioscopy
Secondary outcomes (2)
Complications
Collection of laboratory parameters (CRP, WBC), body temperature and imaging reports of patients.
Measured: Within 7 days after the procedure
Interobserver Agreement in the Detection of Common Bile Duct Stone
Blinded video assessments are conducted three times, every two weeks apart, by three experienced physicians, who review randomly numbered ERCP and cholangioscopy videos.
Measured: Within 2 months after the last patient completes data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start27 Feb 2025
- Primary completion22 Dec 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Xiaofeng,MD, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906782
- Sponsor's protocol ID
- V3.0
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Residual Bile Duct Stones by Cholangioscopy After Negative ERCP Cholangiography and Interobserver Agreement: A Self-Controlled Study
- ClinicalTrials.gov ID
- NCT07906782
- Acronym / sponsor ID
- V3.0
- Conditions
- Choledocholithiasis
- Keywords
- peroral cholangioscopy, ERCP, Choledocholithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 30 Oct 2026 (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.
Common bile duct stones (CBDS) are a common biliary disorder, and endoscopic retrograde cholangiopancreatography (ERCP) is currently the primary minimally invasive approach for their diagnosis and treatment. Complete duct clearance is generally assessed by cholangiography after stone extraction. However, conventional cholangiography may fail to detect residual stones because of air-bubble artifacts, small stone size, biliary sludge, mucosal folds, or impacted stones. Previous studies have demonstrated that occult residual stones may still be identified by direct cholangioscopy even after cholangiography indicates complete duct clearance, highlighting the limitations of conventional cholangiography. Residual stones may increase the risk of post-procedural cholangitis, recurrent biliary symptoms, recurrent CBDS, and the need for repeat ERCP.
Cholangioscopy enables direct visualization of the bile duct lumen and may facilitate the detection of small stones, stone fragments, and impacted stones that are difficult to identify by cholangiography. However, prospective evidence regarding the incremental diagnostic yield of cholangioscopy after negative ERCP cholangiography remains limited. Moreover, visual interpretation during cholangioscopy may be influenced by operator experience, and evidence regarding interobserver and intraobserver agreement remains insufficient. Therefore, this prospective study aims to evaluate the additional diagnostic value of cholangioscopy for detecting stones missed by ERCP cholangiography and to assess the reproducibility of cholangioscopic visual interpretation. The findings may provide clinical evidence for optimizing the assessment of complete bile duct clearance, standardizing the use of cholangioscopy, and reducing adverse outcomes associated with residual bile duct stones.
Detailed description
This prospective study will enroll patients with confirmed or suspected common bile duct stones who undergo endoscopic retrograde cholangiopancreatography (ERCP). Conventional cholangiography will be performed during ERCP to assess the presence of common bile duct stones. Patients with negative cholangiographic findings at the initial examination, as well as patients who undergo stone extraction and subsequently have negative cholangiographic findings indicating apparent duct clearance, will undergo additional cholangioscopic examination.
Cholangioscopy will be performed after negative ERCP cholangiography to directly inspect the bile duct lumen for occult or residual stones that may not be identified by conventional cholangiography. Particular attention will be paid to small stones, biliary sludge or stone fragments, and impacted stones. Findings from ERCP cholangiography and subsequent cholangioscopy will be systematically recorded, and the incremental diagnostic yield of cholangioscopy for detecting stones after negative cholangiographic findings will be evaluated.
In addition, recorded ERCP cholangiography videos and direct cholangioscopy videos will be independently reviewed by three experienced senior endoscopists. Each reviewer will assess whether common bile duct stones are present or absent based on the imaging modality being evaluated. To assess the reproducibility of visual interpretation, each reviewer will perform three separate rounds of evaluation, with a 2-week interval between consecutive rounds. The order of video presentation should be randomized for each round, and reviewers should be blinded to the original procedural findings, the assessments of the other reviewers, and their own previous assessments whenever feasible.
Interobserver agreement among the three reviewers and intraobserver agreement across the three assessment rounds will be analyzed separately for ERCP cholangiography and cholangioscopic visualization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cholangioscopy Following Negative ERCP Cholangiography | Experimental | Procedure: Peroral CholangioscopyThis study employs a self-controlled design. Patients with negative findings on initial ERCP cholangiography or negative cholangiographic findings following stone extraction will be enrolled and undergo subsequent cholangioscopy to detect occult or residual common bile duct stones. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years
- Patients with suspected common bile duct stones based on magnetic resonance cholangiopancreatography (MRCP), computed tomography (CT), or endoscopic ultrasonography (EUS)
Key exclusion criteria (5 listed)
- Pregnancy
- Refusal of written informed consent
- Contraindications to ERCP exist
- Complicated with acute pancreatitis or acute cholangitis
- Coagulation dysfunction
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 |
|---|---|---|
| Peroral CholangioscopyFollowing negative ERCP cholangiography, either during the initial examination or after stone extraction, patients will undergo additional cholangioscopy to directly visualize the bile duct lumen and identify occult or residual common bile duct stones that may have been missed by conventional cholangiography. Cholangioscopic findings will be recorded for subsequent diagnostic evaluation. | Procedure or surgery | Cholangioscopy Following Negative ERCP Cholangiography |
Primary outcome
Presence or Absence of Occult or Residual Common Bile Duct Stones
Time frame: Immediately after cholangioscopy
Presence or Absence of Occult or Residual Common Bile Duct Stones
2 secondary outcomes
Complications
Time frame: Within 7 days after the procedure
Interobserver Agreement in the Detection of Common Bile Duct Stone
Time frame: Within 2 months after the last patient completes data collection
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 Oct 2026.
- 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.
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?
A study testing Peroral Cholangioscopy in people with Choledocholithiasis, run by First People's Hospital of Hangzhou 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 2 inclusion and 5 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 Oct 2026. 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?
Presence or Absence of Occult or Residual Common Bile Duct Stones (time frame: Immediately after cholangioscopy). 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 Oct 2026.