An interventional study of Peroral Cholangioscopy in Choledocholithiasis, sponsored by First People's Hospital of Hangzhou. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by First People's Hospital of Hangzhou · Not applicable, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's enrollment of 31 is below the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →First People's Hospital of Hangzhou is the lead sponsor of 73 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Peroral Cholangioscopy
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.
Presence or Absence of Occult or Residual Common Bile Duct Stones
Presence or Absence of Occult or Residual Common Bile Duct Stones
Time frame: Immediately after cholangioscopy
Complications
Collection of laboratory parameters (CRP, WBC), body temperature and imaging reports of patients.
Time frame: 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.
Time frame: Within 2 months after the last patient completes data collection
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
First People's Hospital of Hangzhou