Bile duct battle: which backup technique works best?
NCT ID NCT06010576
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This study compares two advanced techniques used when doctors have trouble reaching the bile duct during a procedure called ERCP. About 188 adults with difficult bile duct access will be randomly assigned to either an endoscopic ultrasound-guided rendezvous technique or an early precut papillotomy. The goal is to see which method is more successful and has fewer complications within 30 days.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 188 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients age 18 years or older undergoing ERCP with indication for bile duct cannulation * Native major papilla * Difficult bile duct cannulation, defined by the presence of 1 of the following: 1) unsuccessful bile duct cannulation within 10 cannulation attempts, 2) unsuccessful bile duct cannulation within 10 minutes spent in cannulation, or 3) 2 unintended pancreatic duct cannulation or opacification with contrast * Written informed consent available Exclusion Criteria: * Unable to provide written informed consent * Contraindications for endoscopy due to comorbidities * Prior biliary sphincterotomy * Surgically altered upper gastrointestinal anatomy or duodenal obstruction precluding a standard ERCP * Uncorrectable coagulopathy (INR \> 1.5) and thrombocytopenia (platelet \< 50,000) by blood product transfusion * Pregnant patients
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Prince of Wales Hospital, The Chinese University of Hong Kong
RECRUITINGShatin, New Territories, Hong Kong
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