Bile Duct Diseases Clinical Trial
— ERVPPOfficial title:
Endoscopic Ultrasound-guided Rendezvous Technique Versus Early Precut Papillotomy for Difficult Bile Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography: a Multicenter Randomized Controlled 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.
Status | Recruiting |
Enrollment | 188 |
Est. completion date | June 30, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital, The Chinese University of Hong Kong | Sha Tin | New Territories |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong | Gifu University Graduate School of Medicine, Tokyo University |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Intra-procedure, during ERCP | |
Secondary | 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 | From day of procedure to Day 30 after procedure | |
Secondary | 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. | Intra-procedure, during ERCP | |
Secondary | 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 | Intra-procedure (during ERCP) and 3 days post procedure |
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