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Recruiting
NCT05600270
Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation
Conditions: Bile Duct Diseases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 250
Sponsor: Lahey Clinic
Location: United States
Summary
Our aim is to compare outcomes between an angled-tip guidewire and a straight-tip guidewire in cannulation of the common bile duct during ERCP.
This is a randomized, controlled, single-blinded study.
Our primary outcome is success of cannulation and secondary outcomes are incidence of post-ERCP pancreatitis, procedure duration, and rate of complication between the angled wire and straight wire.
Eligibility Criteria
Inclusion Criteria:patients undergoing ERCP for cholangiography, bile or tissue sampling from the gallbladder or bile duct, or for treatment of biliary diseases (removal of common bile duct stones, biliary stent placement)Exclusion Criteria:Patients who are less than 18 years oldPregnant patientsPatients who have undergone previous bile duct cannulation or sphincterotomyPatients who have undergone prior endoscopic balloon dilation or needle-knife fistulotomyPatients who have undergone gastric surgery (Billroth gastrectomy II, Roux-en-Y gastric bypass)Patients with acute pancreatitisPatients who refuse endoscopic interventionPatients with ampullary tumor, duodenal stenosis, or pre-operatively proven pancreaticobiliary malunion
Source: ClinicalTrials.gov (NCT05600270). StuddyBuddy aggregates publicly available trial information.