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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
EUS-guided rendezvous
Procedure/SurgeryA linear array echoendoscope would be used to evaluate the common bile duct and left intrahepatic duct in order to identify the optimal route for biliary access by fine needle. Using a 19 gauge EUS needle, the dilated biliary tree will be accessed by either a transduodenal puncture to the common bile duct or a transgastric puncture to the left intrahepatic duct under direct EUS guidance. The optimal access route will be based on patient's anatomy after EUS assessment and left to the discretion of the investigator. Next, a guidewire would be advanced through the needle into the bile duct and out of the papillary orifice. The echoendoscope would then be exchanged to a duodenoscope for ERCP. The EUS rendezvous ERCP procedure will be completed by retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the rendezvous guidewire to obtain biliary access.
Early precut papillotomy group
Procedure/SurgeryThe precut papillotomy would be performed with 1 of the following acceptable techniques per the usual practice of the study investigator and institution: 1) conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3) transpancreatic precut papillotomy by papillotome
Treatment groups
188 Participants
are divided into 2 treatment groupsGroup A: EUS-guided rendezvous group (EUS RV group)Active comparator 1 intervention
Group B: Early precut papillotomy group (EPP group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
The first session technical success for biliary access by EUS-guided rendezvous technique and early precut papillotomy in patients with difficult biliary access during ERCP
Technical success by EUS RV is defined as successful EUS-guided needle access of bile duct confirmed by bile aspiration and cholangiogram, advancement of guidewire into bile duct and out of papilla, and obtaining deep biliary cannulation by retrieving the rendezvous guidewire into duodenoscope or by cannulation alongside the rendezvous guidewire. Technical success by Early Precut Papillotomy is defined as successful bile duct access by 1 of the 3 acceptable precut techniques in achieving deep biliary cannulation, confirmed by bile aspiration and cholangiogram.
Time frame
Intra-procedure, during ERCPSecondary outcomes
1
Procedure-related serious adverse events in the EUS-guided rendezvous group and the early precut papillotomy group within 30 days of ERCP
Procedure-related serious adverse events include perforation, bleeding, biliary sepsis, pancreatitis, bile leak, or procedure-related mortality
Time frame
From day of procedure to Day 30 after procedure2
Procedure time to achieve biliary access by the assigned study biliary access technique
EUS RV group: time from EUS-guided needle access of bile duct to successful biliary cannulation by ERCP. Early Precut Papillotomy group: time from precut initiation to successful biliary cannulation.
Time frame
Intra-procedure, during ERCP3
Need for rescue biliary drainage procedures in patients with failed biliary access by the assigned study technique, including crossover to the other study biliary access technique, need for PTBD by interventional radiology
Intra-procedure: crossover to the other study biliary access technique. Within 3 days of procedure: need for percutaneous transhepatic biliary drainage by interventional radiology
Time frame
Intra-procedure (during ERCP) and 3 days post procedureSponsors and contacts
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Chinese University of Hong Kong
Lead sponsor
Tokyo University
Collaborator
University of Toyama
Collaborator
Shizuoka Cancer Center
Collaborator
Tokyo Women's Medical University
Collaborator
Shiga University of Medical Science, Japan
Collaborator
Asian Institute of Gastroenterology, India
Collaborator
National Taiwan University Hospital
Collaborator
Source ClinicalTrials.gov