Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy
ConditionBile Duct Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
Selective bile duct cannulation is the most important step in endoscopic retrograde cholangiopancreatography (ERCP) for treatment of benign and malignant pancreatobiliary diseases, but it may fail in up to 15% of cases. Precut papillotomy is an advanced ERCP cannulation technique recommended by guidelines for rescue of difficult biliary access, but it is not without limitations. Endoscopic ultrasound (EUS)-guided biliary drainage is a novel interventional EUS technique that has been increasingly performed after failed biliary access by advanced ERCP cannulation techniques.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- EUS-guided rendezvous
- Early precut papillotomy group
Treatment groups
188 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chinese University of Hong Kong
Lead sponsor
Tokyo University
Collaborator
Gifu University Graduate School of Medicine
Collaborator
Source ClinicalTrials.gov